A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis (Phase 3 Trial)

To investigate the superiority of 1% OPA-15406 foam to the vehicle in adult patients with atopic dermatitis (AD).

Start Date01 Oct 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

NCT07184645

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% OPA-15406 Foam to the Vehicle in Children With Atopic Dermatitis in Combination With an Open-label, Uncontrolled Trial to Evaluate the Safety and Efficacy of 0.3% and 1% OPA-15406 Foam in Infants Under 2 Years of Age and Children With Atopic Dermatitis (Phase 3 Trial)

To investigate the superiority of 0.3% OPA-15406 foam to the vehicle in children with atopic dermatitis (AD)

Start Date01 Sep 2025

Sponsor / Collaborator

Otsuka Pharmaceutical Co., Ltd.

NCT05650320

/ CompletedPhase 3

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Clinical Trial to Demonstrate the Superiority of 0.3% and 1% OPA-15406 Ointment Versus Vehicle in Pediatric Subjects with Atopic Dermatitis

A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.

Start Date17 Feb 2023

Sponsor / Collaborator

Otsuka Beijing Research Institute

100 Clinical Results associated with Difamilast

100 Translational Medicine associated with Difamilast

100 Patents (Medical) associated with Difamilast

Literatures (Medical) associated with Difamilast

01 Feb 2026·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Efficacy and safety of treatments for atopic dermatitis: a model based meta-analysis of randomized controlled trials

Review

Author: Liu, Yifan ; Zheng, Qingshan ; Chen, Ming ; Gong, Yiwen ; Jia, Jianmin ; Yi, Qianhui ; Zhang, Lingxiao ; Gu, Xiang ; Li, Lujin ; Xu, Ling

PURPOSE:

We aimed to quantitatively compare the efficacy and safety of currently marketed Atopic Dermatitis (AD) therapies and placebo in AD patients, providing evidence-based guidance for clinical treatment selection.

METHODS:

Randomized controlled trials (RCTs), drug labels, and regulatory review documents related to AD treatments and placebo were retrieved from PubMed, FDA, EMA, NMPA, and PMDA databases from inception to July 11, 2023. The response rates of Eczema Area and Severity Index (EASI) 75, clear (0) or almost clear (1) with a ≥ 2-point improvement in Investigator's Global Assessment (IGA) including validated IGA (vIGA) (hereinafter referred to as IGA), EASI 90 and ≥ 4-point improvement in Pruritus Numerical Rating Scale (PP-NRS4) were used as the efficacy index. Time-effect models were subsequently established using a model-based meta-analysis (MBMA). For treatments not suitable for MBMA or subgroup analyses stratified by disease severity and age groups, meta-analyses were conducted. Safety outcomes were compared via pooled analysis.

RESULTS:

A total of 274 articles and 4 FDA review documents were identified, with 77 studies and 2 FDA reviews ultimately included (total sample size: 20,262). Results showed that all topical and systemic medications demonstrated superior efficacy (EASI 75 response rate) to placebo. Among topical treatments, methylprednisolone showed the highest efficacy. For non-steroidal topicals, ruxolitinib cream exhibited the best efficacy, followed by tacrolimus ointment and difamilast ointment. Among systemic treatments, upadacitinib demonstrated the highest efficacy, followed by abrocitinib, with dupilumab ranking third as the most effective biologic. Baricitinib showed relatively lower efficacy. Biologics exhibited slower onset compared to other treatments. Safety analysis revealed higher overall adverse event incidence with systemic treatments versus topical treatments.

CONCLUSION:

MBMA was conducted for the time courses of several efficacy index. In conclusion, results showed that there is still a lack of treatment methods that balance efficacy, safety and speed of onset. The results of this MBMA can be used as a reference for optimizing clinical medication and provide a basis for decision-making in the future development of new AD drugs.

01 Jan 2026·Dermatology and Therapy

A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis

Article

Author: Tsubouchi, Hidetsugu ; Ohya, Yukihiro ; Imamura, Tomomi ; Baba, Naoko ; Yokota, Daisuke ; Saeki, Hidehisa

INTRODUCTION:

Difamilast is the first selective phosphodiesterase 4 inhibitor approved for atopic dermatitis (AD) in Japan. A phase 3, 52-week, open-label study was conducted to evaluate efficacy and safety of difamilast ointments in Japanese infants with AD aged 3 to < 24 months, because the clinical study in this population has not been conducted.

METHODS:

Infants (n = 41) received difamilast 0.3% ointment twice daily in a 4-week primary evaluation period, and subsequently received difamilast 0.3% or 1% ointment on the basis of the existing clinical symptoms in a 48-week, long-term extension period.

RESULTS:

The response rate in Investigator's Global Assessment score was 56.1% at week 4, and it increased to 75.6% at week 52. The response rate in Eczema Area and Severity Index 75 was 82.9% at week 4, and the approximately same response rate was maintained at 80.5% at week 52. Adverse events (AEs) were reported in 41 (100.0%) infants, most of which were mild or moderate in severity. The most frequently observed AE was nasopharyngitis (82.9%), followed by gastroenteritis (46.3%). The investigational medicinal product-related AE, folliculitis, was reported in one infant (2.4%). No clinically relevant abnormalities were reported in clinical laboratory tests, physical examinations, and vital signs.

CONCLUSION:

Difamilast ointments applied twice daily to Japanese infants with AD aged 3 to < 24 months for up to 52 weeks are effective and well tolerated, indicating a new useful treatment option for this population.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT05372653.

01 Sep 2025·JOURNAL OF DERMATOLOGICAL SCIENCE

Difamilast induces human beta defensin 3 production via CREB and NRF2 in human keratinocytes

Letter

Author: Yumine, Ayako ; Tsuji, Gaku ; Nakahara, Takeshi ; Takemura, Masaki

News (Medical) associated with Difamilast

06 Oct 2022

·www.biospace.com

Devonian Health Group Announces Peer-Reviewed Publication of Thykamine™ Positive Phase 2 Clinical Trial Results in Journal of Drugs in Dermatology

Clinical Study demonstrated dual benefit mode of action of Thykamine™ in mild-to-moderate Atopic Dermatitis: Statistically significant effect on Atopic Dermatitis evaluated by measure of IGA, BSA and POEM Statistically beneficial effect on Pruritis (‘‘itch’’) QUEBEC CITY--(BUSINESS WIRE)-- Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD ; OTCQB: DVHGF), a clinical stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, today announced the publication of Thykamine™ positive phase 2 trial in adult patients with mild-to-moderate Atopic Dermatitis (AD) in the peer-reviewed Journal of Drugs in Dermatology (JDD). This article, titled ‘‘Phase 2 Trial of Topical Thykamine in Adults with Mild to Moderate Atopic Dermatitis’’ has been published in a JDD special issue focus on Atopic Dermatitis (J Drugs Dermatol 21(10): 1091-1097, October 2022). The paper by Lynde et al. discloses the results of the Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial conducted in 162 adult patients with mild-to-moderate AD. In this 4-week multicentre study, a significantly greater proportion of adult patients treated with Thykamine™ cream 0.10% achieved an IGA of clear/almost clear and at least a 2-grade improvement from baseline in IGA (30.8%) compared to placebo (6.7%; P =.014). The benefit of Thykamine™ cream 0.10% was supported by a statistically significant effect on secondary endpoints of Body Surface Area (BSA), pruritis, and Patient-Oriented Eczema Measure score (POEM). A significant reduction in %BSA affected from baseline was demonstrated at all study visits. These changes differentiated significantly from placebo from Day 14 until Day 29 (p ≤ 0.001). Pruritus (‘‘itch’’) was rapidly improved from baseline by Day 7 with a statistically difference vs placebo at Day 21 and Day 29 (p ≤ 0.01). POEM outcome was statistically significant from placebo at day 21 and 29 (p ≤ 0.01). Thykamine™, at all doses, was well tolerated with an adverse event pro placebo. ‘‘We are proud to have our innovative Thykamine™ study results published in a reputable, peer-reviewed scientific journal,” said Dr André P. Boulet, PhD, Chief Scientific Officer of Devonian. ‘‘The efficacy of Thykamine™ obtained in this clinical trial compared favourably to published results of other therapeutic products such as the phosphodiesterase inhibitors (PDE4)1,2 and calcineurin inhibitors.3 To our knowledge, it is the first time that clinical data revealed that a Botanical Drug candidate can be as potent as a product derived from chemical synthesis. Furthermore, the use of Thykamine™ was associated with a rapid improvement in itch in patients with mild to moderate AD. The fast onset of action and magnitude of itch relief associated with Thykamine™ cream treatment suggests that it may provide meaningful improvement in quality of life and addresses an unmet need for patients with AD,’’ added Dr Boulet. About Atopic Dermatitis (AD) AD, also known as eczema, is a type of inflammation of the skin. It results in itchy, red, swollen, and cracked skin that may lead to secondary infection. The condition typically starts in childhood with changing severity over the years. Although the cause of AD is unknown, it is believed to involve genetics, a compromised immune system and can be triggered by environmental factors. AD is the most common skin disease4 and its prevalence continues to increase worldwide. In the United States, the incidence has been reported to be 15-30% of children5. The severity of AD can be categorized into three stages, mild, moderate, and severe. The mild and moderate forms constitute approximately 67% and 26% respectively of the AD childhood patient population. A similar distribution has been reported in the adult patient population (71% and 26% respectively) 6,7. There is currently an enormous unmet need for new, effective, and well-tolerated treatment options in AD8. The global atopic dermatitis market is expected to exceed US $21,8 billion in sales by 20279. About Thykamine Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a phase II clinical study in patients with mild-to-moderate atopic dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. (Devonian)is a late-stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory-autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a US-FDA set of regulatory guidelines favouring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian’s flagship product, Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with Mild-to-Moderate distal Ulcerative Colitis and in a large phase 2 clinical trial in adult patients with Mild-to-Moderate Atopic Dermatitis. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Acquired in 2018, Altius Healthcare Inc., its commercialization subsidiary, brings opportunities for further diversification and growth potential. Devonian is listed on the TSX Venture Exchange (TSXV:GSD) as well as the OTCQB Venture Exchange (OTCQB:DVHGF) For more information, visit References Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesteras 4 (PDE4) inhibitors for the topical treatment of atopic dermatitis (AD) in children and adults. J. Am. Acad. Dermatol., Vol 75 (3), 494-503, 2016. Hanifin JM., Ellis CN, Frieden IJ, et al. OPA-15406, a novel topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (A): A phase-II randomized, double-blind, placebo-controlled study. J Am Acad Dermatol, Vol 75 (2), 297-305, 2016. Product Monograph, Elidel Cream 1%, Valeant Canada, 2014 Peng W., Novak N. Pathogenesis of atopic dermatitis. Clinical et Experimental Allergy 2015, 45 : 566-574. Amy Huang, MD, Christine Cho, MD, Donald Y.M. Leung, MD, PhD, and Kanwaljit Brar, MD. Atopic Dermatitis: Early Treatment in Children. Curr Treat Options Allergy. 2017 Sep; 4(3): 355–369. Silverberg JI, Simpson EL. Associations of childhood eczema severity: A US population-based study. Dermatitis 2014; 25(3):107-114. Chaplin S. Guide to treatments used for atopic dermatitis in adults. Prescriber 2016: 27(10): 30-39. Leung DYM. Guttman-Yassky E. Assessing the current treatment of atopic dermatitis: Unmet needs. J. of Allergy and Clinical Immunology. 2017; 139(4) Suppl.: S47-48. Market Data Forecast, Global Atopic Dermatitis Treatment Market Size, Share, Trends, COVID-19 Impact & Growth Analysis Report - Segmented By Treatment Type, Route Of Administration, Distribution Channel & Region - Industry Growth, Trends & Forecast (2021 to 2026), April 2021. Forward-Looking Statements This press release contains forward-looking statements about Devonian’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, the intended use of proceeds of the Offering, the final approval of the TSX Venture Exchange in connection with the Offering, the above “About Devonian” paragraph, Devonian’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian’s prospectus dated April 21st, 2017 under the heading “Risk Factors” related to Devonian’s business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

26 May 2022

·www.biospace.com

Devonian Health Group Announces the Journal of Drugs in Dermatology Acceptance for Publication of Thykamine™ Positive Phase 2 Clinical Trial Results in Atopic Dermatitis

May 26, 2022 12:45 UTC QUEBEC CITY--(BUSINESS WIRE)-- Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD ; OTCQB: DVHGF), a clinical stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, today announced the acceptance for publication of results from its positive phase 2 trial of Thykamine™ in patients with mild-to-moderate Atopic Dermatitis (AD) in the peer-reviewed Journal of Drugs in Dermatology (JDD). This JDD article, titled ‘‘Phase 2 Trial of Topical Thykamine™️ in Adults with Mild to Moderate Atopic Dermatitis’’ will be published in a special issue on Atopic Dermatitis planned for October 2022. The Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted in 162 patients with mild-to-moderate AD. In this 4-week, multicentre study, adult patients were randomized to receive Thykamine™ cream 0.05%, 0.10%, 0.25% or vehicle cream (placebo) twice daily. The primary efficacy endpoint was the Investigator Global Assessment (IGA) success rate defined as percentage of patients with an IGA score of 0 or 1 with greater than or equal to 2-grade reduction at week 4. Secondary endpoints included body surface area (BSA), pruritus and the Patient-Oriented Eczema Measure (POEM), among others. The benefit of Thykamine™ cream 0.10% was supported by a statistically significant effect on the primary and secondary endpoints of Body Surface Area (BSA), pruritis, and Patient-Oriented Eczema Measure score (POEM). “We are excited that Journal of Drugs in Dermatology has elected to publish, in a special issue on Atopic Dermatitis, the results of our Phase 2 study on Thykamine™️ which shows significant positive results posted by our product for the treatment of mild-to-moderate atopic dermatitis. These positive results should validate the potential of Thykamine™️ in the armamentarium to treat this condition affecting millions of children and adults around the world,” said Dr André P. Boulet, PhD, President and Chief Executive Officer of Devonian. “The efficacy of Thykamine™ obtained in this Phase 2 clinical trial compared favourably to published results posted by other therapeutic products such as phosphodiesterase inhibitors ((PDE4)1,2 and calcineurin inhibitors.3 To our knowledge, it is the first time that clinical trial data has demonstrated that a botanical drug candidate can be as potent as a product derived from chemical synthesis,” added Dr. Boulet. About Atopic Dermatitis (AD) Atopic Dermatitis or eczema,is a chronic inflammatory disease of the skin that is recurrent. It is characterized by itchy, red, swollen and cracked skin that may lead to secondary infections. The condition typically starts in childhood with changing severity over the years. Although the cause of AD is unknown, it is believed to involve genetics, a compromised immune system and can be triggered by environmental factors. AD is the most common skin disease4 and its prevalence continues to increase worldwide. In the United States, the incidence has been reported to be 10-20% of children with new diagnoses at almost 11% per year5. The severity of AD can be categorized into three stages, mild, moderate, and severe. The mild and moderate forms constitute approximately 67% and 26% respectively of the AD childhood patient population. A similar distribution has been reported in the adult patient population (71% and 26% respectively) 6,7. There is currently an enormous unmet need for new, effective, and well-tolerated treatment options in AD8. The global atopic dermatitis market is expected to exceed US $21,8 billion in sales by 20279. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a phase II clinical study in patients with mild-to-moderate atopic dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. (Devonian) is a late-stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory-autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a US-FDA set of regulatory guidelines favouring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian is listed on the TSX Venture Exchange (TSXV:GSD) as well as the OTCQB Venture Exchange (OTCQB:DVHGF) For more information, visit References Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesteras 4 (PDE4) inhibitors for the topical treatment of atopic dermatitis (AD) in children and adults. J. Am. Acad. Dermatol., Vol 75 (3), 494-503, 2016. Hanifin JM., Ellis CN, Frieden IJ, et al. OPA-15406, a novel topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (A): A phase-II randomized, double-blind, placebo-controlled study. J Am Acad Dermatol, Vol 75 (2), 297-305, 2016. Product Monograph, Elidel Cream 1%, Valeant Canada, 2014 Peng W., Novak N. Pathogenesis of atopic dermatitis. Clinical et Experimental Allergy 2015, 45 : 566-574. Eichenfield F, Ellis CN, Mancini AJ, Paller AS, Simpsom EL. Atopic Dermatitis: Epidemiology and Pathogeneses Update. Semin Cutan Med Surg 2012, Sep; 31 (3 Suppl): S3-5. Silverberg JI, Simpson EL. Associations of childhood eczema severity: A US population-based study. Dermatitis 2014; 25(3):107-114. Chaplin S. Guide to treatments used for atopic dermatitis in adults. Prescriber 2016: 27(10): 30-39. Leung DYM. Guttman-Yassky E. Assessing the current treatment of atopic dermatitis: Unmet needs. J. of Allergy and Clinical Immunology. 2017; 139(4) Suppl.: S47-48. Market Data Forecast, Global Atopic Dermatitis Treatment Market Size, Share, Trends, COVID-19 Impact & Growth Analysis Report - Segmented By Treatment Type, Route Of Administration, Distribution Channel & Region - Industry Growth, Trends & Forecast (2021 to 2026), April 2021. Forward-Looking Statements This press release contains forward-looking statements about Devonian’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, the intended use of proceeds of the Offering, the final approval of the TSX Venture Exchange in connection with the Offering, the above “About Devonian” paragraph, Devonian’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian’s prospectus dated April 21st, 2017 under the heading “Risk Factors” related to Devonian’s business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

25 Mar 2021

·www.biospace.com

Devonian Health Group Provides More Details on Previously Announced Positive Topline Results From Phase 2 Clinical Trial of Thykamine™ in Adult Population with Mild-to-Moderate Atopic Dermatitis and the Grant of Stock Options.

QUEBEC CITY--(BUSINESS WIRE)-- Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD), a clinical stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, provides further details on previously announced results of Thykamine™ Phase 2 clinical trial for the treatment of mild-to-moderate atopic dermatitis (AD). In this 4-week, phase 2, randomized, double-blind, multicentre, placebo-controlled study, adult patients with mild-to-moderate AD were randomized to receive Thykamine™ cream 0.05%, 0.10%, 0.25% or vehicle cream (placebo) twice daily. The primary efficacy endpoint was the Investigator Global Assessment (IGA) success rate defined as percentage of patients with an IGA score of 0 or 1 with greater than or equal to 2-grade reduction at week 4. Secondary endpoints included Body Surface Area (BSA) and Eczema Area and Severity Index (EASI). A total of 162 patients, spread over several sites in Canada, were recruited for this study. IGA success rates at week 4 were 6.7% for placebo (vehicle cream), 19.0% for Thykamine™ cream 0.05% (p=0.053 vs placebo), 30.8% Thykamine™ cream 0.10% (p=0.014 vs placebo) and 12.1% for Thykamine™ cream 0.25% (p=0.461 vs placebo). Success rate over placebo of Thykamine™ cream 0.1% was not only reached at week 4 but also at week 3 (p = 0.04), resulting in a fast onset of the therapeutic effect. As such, Thykamine™ cream 0.10% has been retained for Phase 3 trials. In addition, Thykamine™ achieved statistically significant differences, compared to placebo, in its key secondary efficacy endpoint, i.e. BSA. Lastly, Thykamine™ was well-tolerated, as very few adverse events were reported. "The efficacy of Thykamine™ obtained in this clinical trial was as expected and compared favourably to published results of other therapeutic products such as the phosphodiesterase inhibitors (PDE4)1,2 and calcineurin inhibitors,3 demonstrating that a Botanical Drug candidate can be as potent as a product derived from chemical synthesis." said Dr André P. Boulet, President and CEO of Devonian. "With the successful completion of this dose ranging study, we can now move into phase 3 clinical development in the adult patients. We are also planning a clinical trial within the pediatric patient population" added Dr Boulet. Grant of Stock Options In addition, the Company announces that the Board of Directors has approved the grant of 60,000 stock options (the "Options") to a member of the Board of Directors. These options are exercisable on the grant date, at a price of $ 0.20, for a period of 10 years. About Atopic Dermatitis (AD) AD, also known as eczema, is a type of inflammation of the skin. It results in itchy, red, swollen, and cracked skin that may lead to secondary infection. The condition typically starts in childhood with changing severity over the years. Although the cause of AD is unknown, it is believed to involve genetics, a compromised immune system and can be triggered by environmental factors. AD is the most common skin disease4 and its prevalence continues to increase worldwide. In the United States, the incidence has been reported to be 10-20% of children with new diagnoses at almost 11% per year5. The severity of AD can be categorized into three stages, mild, moderate, and severe. The mild and moderate forms constitute approximately 67% and 26% respectively of the AD childhood patient population. A similar distribution has been reported in the adult patient population (71% and 26% respectively) 6,7. There is currently an enormous unmet need for new, effective, and well-tolerated treatment options in AD8. About Thykamine™ Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis. Thykamine™ is currently under development as treatment for ulcerative colitis and atopic dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in North America, Europe and Asia. About Devonian Devonian Health Group Inc. is a late-stage botanical pharmaceutical corporation with novel therapeutic approaches to targeting unmet medical needs. Devonian's core strategy is to develop prescription botanical drugs from plant materials and algae for the treatment of inflammatory-autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a US-FDA set of regulatory guidelines favouring a more efficient drug development pathway for prescription botanical drug products over those of traditional prescription medicines. Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian Health Group Inc. was incorporated in 2015 and is headquartered in Québec, Canada where it owns a state-of-the art extraction facility with full traceability ‘from the seed to the pill’. Acquired in 2018, Altius Healthcare Inc., its commercialization partner, brings opportunities for further diversification and growth potential. Devonian is traded publicly on the TSXV Exchange (TSXv:GSD). For more information, visit References Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesteras 4 (PDE4) inhibitors for the topical treatment of atopic dermatitis (AD) in children and adults. J. Am. Acad. Dermatol., Vol 75 (3), 494-503, 2016. Hanifin JM., Ellis CN, Frieden IJ, et al. OPA-15406, a novel topical, nonsteroidal, selective phosphodiesterase-4 (PDE4) inhibitor, in the treatment of adult and adolescent patients with mild to moderate atopic dermatitis (A): A phase-II randomized, double-blind, placebo-controlled study. J Am Acad Dermatol, Vol 75 (2), 297-305, 2016. Product Monograph, Elidel Cream 1%, Valeant Canada, 2014 Peng W., Novak N. Pathogenesis of atopic dermatitis. Clinical et Experimental Allergy 2015, 45 : 566-574. Eichenfield F, Ellis CN, Mancini AJ, Paller AS, Simpsom EL. Atopic Dermatitis: Epidemiology and Pathogeneses Update. Semin Cutan Med Surg 2012, Sep; 31 (3 Suppl): S3-5. Silverberg JI, Simpson EL. Associations of childhood eczema severity: A US population-based study. Dermatitis 2014; 25(3):107-114. Chaplin S. Guide to treatments used for atopic dermatitis in adults. Prescriber 2016: 27(10): 30-39. Leung DYM. Guttman-Yassky E. Assessing the current treatment of atopic dermatitis: Unmet needs. J. of Allergy and Clinical Immunology. 2017; 139(4) Suppl.: S47-48. Forward Looking Statements This press release contains forward-looking statements about Devonian’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Devonian’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical and cosmeceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Devonian to take advantage of business opportunities in the pharmaceutical and cosmeceutical industries, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Devonian’s prospectus dated April 21st, 2017 under the heading “Risk Factors” related to Devonian’s business. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

100 Deals associated with Difamilast

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	Japan	Otsuka Pharmaceutical Co., Ltd.	27 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 3	United States	Acrotech Biopharma LLC	01 Oct 2022
Moderate Atopic Dermatitis	Phase 3	United States	Acrotech Biopharma LLC	01 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03911401 \| NCT03908970 \| NCT02068352 (FDA_CDER) Manual	Not Applicable	Dermatitis, Atopic	612	ADQUEY (Trial 1(Multinational))	ahattayeku(ijwcfcvepj) = trqmzbzifh bmawdlyzmq (lgsvvzqkud )	Positive	12 Feb 2026
				Vehicle ointment (Trial 1(Multinational))	ahattayeku(ijwcfcvepj) = tgwswhtirc bmawdlyzmq (lgsvvzqkud )
NCT05372653 (Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Dermatitis, Atopic	41	Difamilast ointment	oiwfncfdmu(yfowetpevj) = The investigational medicinal product-related AE, folliculitis, was reported in one infant (2.4%) pngvwcqtrk (qcpzljxnsv ) View more	Positive	31 Oct 2025
NCT05372653 (CTgov)	Phase 3	Dermatitis, Atopic	41	OPA-15406 (0.3% OPA-15406)	byoqmtizeo = tuwlfjgmio rltlsbpkvh (bofqrrprta, jdavwutvpo - njzatednih) View more	-	30 Mar 2025
				OPA (1% OPA-15406)	aixjyufyav(exmjzzbefs) = kaohuksohm fxmijszmbw (armmuiedon, cswmoplead - caprftpgtt) View more
NCT05372653 (Pubmed)	-	Dermatitis, Atopic	41	Difamilast	mujmdevsrw(zacufpthaq) = atfhhajsku kadbsmbbav (cnrryuafrx ) View more	Positive	01 Jul 2024
NCT03961529 (Pubmed) Manual	Phase 3	Dermatitis, Atopic	366	difamilast (Adult patients)	mvojvyazqa(blcxaimgzx) = sfnlqbdzce scwvvkvtcl (psffbdzkno ) View more	Positive	18 Jun 2022
				difamilast (pediatric patients)	mvojvyazqa(blcxaimgzx) = jjindzahni scwvvkvtcl (psffbdzkno ) View more
NCT02068352 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Mild Atopic Dermatitis	121	OPA-15406 (0.3% OPA-15406)	olstpyhqgx = fwtmdzawmv lgsgnwdukd (owukhdekut, hryefgtocx - rlsaystxnj) View more	-	23 Nov 2021
				OPA-15406 (1% OPA-15406)	olstpyhqgx = foioizpuos lgsgnwdukd (owukhdekut, qsjjghboyi - hfihirlwwx) View more
NCT03961529 (CTgov)	Phase 3	Dermatitis, Atopic	366	OPA-15406 (Adult: 1% OPA-15406 Ointment)	dxuecxvsur = ejcpvitozl agzqvanihr (fnhnncddkx, sawufuhjzq - gvdcwacxry) View more	-	19 Nov 2021
				OPA-15406 (Pediatric: 0.3% OPA-15406 Ointment)	dxuecxvsur = xvpciwxefh agzqvanihr (fnhnncddkx, slmesqkayf - ulxpndoogj) View more
NCT03911401 (CTgov)	Phase 3	Dermatitis, Atopic	251	0.3% OPA-15406 (0.3% OPA-15406)	woswlbavfi = rmtgsswlzh dswoapzvsx (njwbkdaoxp, gfjvrkdjvw - oehshvjoyc) View more	-	25 Jan 2021
				1% OPA-15406 (1% OPA-15406)	woswlbavfi = jpxxavjfsu dswoapzvsx (njwbkdaoxp, mgunpagtvg - egtwndaufo) View more
NCT03908970 (CTgov)	Phase 3	Dermatitis, Atopic	364	1% OPA-15406 (1% OPA-15406)	kgrcvblkfo = mvuhqhhghf mjggcqmrgj (frfdcpdvjw, dmtspthwbq - wyyictbtry) View more	-	25 Jan 2021
				Placebos (Placebo)	kgrcvblkfo = ttgwcqoeqo mjggcqmrgj (frfdcpdvjw, jppoarzbqa - mnzzqhmwju) View more
NCT03018691 (CTgov)	Phase 2	Dermatitis, Atopic	73	OPA-15406 (0.3% OPA-15406 Ointments)	smwzmsiyzx = vcsqxdgrnb yoalwnavnv (gsvcmuzqjo, rrgzyethix - whmtuezmrd) View more	-	23 Jul 2020
				OPA-15406 (1% OPA-15406 Ointments)	smwzmsiyzx = mcsmhhdmtj yoalwnavnv (gsvcmuzqjo, jvailrdbuv - obauotasra) View more

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