A Randomized, Double-blind, Placebo-controled, Phase 2a Trial Evaluating the Safety and Initial Efficacy of Resomelagon in Patients With Dengue Infection

The goal of this clinical trial is to understand if Resomelagon can treat adult patients with Dengue virus infection. The main questions the investigators aim to answer are:
Is Resomelagon safe to use in patients with Dengue? Is Resomelagon able to reduce the duration of illness? (defined by clinical and laboratory criteria) Participants will be allocated to Resomelagon or placebo groups in this study and asked to take the medication and submitted to blood tests.

Start Date01 Feb 2026

Sponsor / Collaborator

Universidade Federal de Minas Gerais

CTIS2024-514981-37-00

/ RecruitingPhase 2

A randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.

Start Date05 Dec 2024

Sponsor / Collaborator

SynAct Pharma ApS

NCT06671054

/ RecruitingPhase 2

A Randomized, Double Blind, Placebo-controlled, Dose Response, Phase II, Multicentre Trial to Evaluate the Efficacy and Safety of Oral AP1189 Administered at the Doses of 40, 70, or 100 mg for 12 Weeks in Combination With Methotrexate, in DMARD-naïve Participants With Early Rheumatoid Arthritis and Active Inflammation.

The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.

Start Date01 Oct 2024

Sponsor / Collaborator

SynAct Pharma ApS

[+1]

100 Clinical Results associated with Resomelagon

100 Translational Medicine associated with Resomelagon

100 Patents (Medical) associated with Resomelagon

Literatures (Medical) associated with Resomelagon

01 Nov 2025·PHYTOMEDICINE

Baicalin ameliorates high-fat diet induced MAFLD by inhibiting ERK/PPARγ/CD36 pathway

Article

Author: Liu, Hanqiang ; Xu, Xiaona ; Gao, Peipei ; Su, Zheng ; Wang, Xiaohui ; Li, Yuting ; Li, Mengying ; Zhang, Xianjiao ; Zhang, Lei ; Lei, Jiamin

OBJECTIVE:

Metabolic dysfunction-associated fatty liver disease (MAFLD) is a global health concern with limited therapeutic options. Baicalin (BA), a natural flavonoid, has shown promise in ameliorating lipid metabolism and liver function. This study employed an integrated strategy combining network pharmacology, molecular docking, and in vivo/in vitro validation to elucidate the novel protective mechanism of BA against MAFLD through modulation of the ERK/PPARγ/CD36 signaling axis in high-fat diet (HFD)-induced mice.

METHODS:

Potential targets of BA and MAFLD were identified from multiple databases, with common targets screened via Venn analysis. A protein-protein interaction (PPI) network was constructed and visualized based on degree values. Gene Ontology (GO) and KEGG pathway enrichment analyses were conducted using R software. Molecular docking and surface plasmon resonance (SPR) experiments were performed to evaluate the binding affinity of BA to key targets, and a positive control was also added. For the in vivo study, MAFLD was induced in mice via 16-week HFD. Body weight, average food intake, glucose metabolism (GTT, ITT), serum lipid metabolism indexes (TG, TC, HDL-C, LDL-C), and serum liver function markers (ALT, AST, ALP, GGT) were assessed. Hepatic lipid deposition was analyzed using H&E, oil red O staining and NAS score. The protein and mRNA expression of p-ERK, PPARγ, CD36, SREBP-1c, FAS, ACC, and SCD1 were examined by Western blot or RT-PCR, with CD36 expression was further confirmed by immunofluorescence. In vitro, cell viability was measured using CCK8 at 12, 24, and 48 h after BA treatment. LO2 cells were treated with BA, free fatty acids (FFA), SCH772984 (a p-ERK inhibitor), or resomelagon (a p-ERK agonist), and lipid accumulation and protein expression were evaluated using Western blot and oil red O staining.

RESULTS:

Network pharmacology analysis identified 37 common targets between BA and MAFLD, with PPARγ confirmed as a high-affinity BA target by molecular docking (pKi = -11.6096 µM) and SPR (K_D = 6.84 × 10^-7 M). In vivo, BA significantly reduced body weight (p < 0.05) and improved glucose metabolism (p < 0.05), lowered serum TG, TC, LDL-C levels (p < 0.05) and pro-inflammatory cytokines IL-1β, IL-6, TNF-α levels (p < 0.05). Additionally, BA attenuated hepatic steatosis and downregulated the expression levels of p-ERK, PPARγ and CD36 in liver tissues (p < 0.05). In vitro, BA or SCH772984 inhibited p-ERK, PPARγ, and CD36 expression (p < 0.05), as well as lipid accumulation in FFA-treated LO2 cells (p < 0.05). The resomelagon-treated cells were consistent with the effect of FFA, while BA could reverse the effects (p < 0.05).

CONCLUSION:

This study by using integrates computational prediction demonstrated that PPARγ was the main target of BA, then with multi-level experimental validation, elucidated that BA could ameliorate MAFLD by modulating core ERK/PPARγ/CD36 signaling pathway, highlighting a novel therapeutic target for MAFLD.

01 Dec 2024·British Journal of Pharmacology

Effects of a pro‐resolving drug in COVID‐19: preclinical studies to a randomized, placebo‐controlled, phase Ib/IIa trial in hospitalized patients

Article

Author: Silva, Barbara L. V. ; Costa, Vivian V. ; Almeida, Pedro R. J. ; Milhorato, Larissa B. ; Queiroz‐Junior, Celso M. ; Jonassen, Thomas E. N. ; Teixeira, Danielle C. ; Teixeira, Mauro M. ; Periard, Alexandre M. ; Fonseca, Talita C. M. ; Tana, Fernanda L. ; Avila, Renata E. ; Perretti, Mauro ; Serufo, Angela V. ; Alcantara, Katlen M. M. ; Resende, Carolina B. ; Santos, Felipe R. ; Souza, Renan P.

Introduction:

Pro‐resolving molecules may curb disease caused by viruses without altering the capacity of the host to deal with infection. AP1189 is a melanocortin receptor‐biased agonist endowed with pro‐resolving and anti‐inflammatory activity. We evaluated the preclinical and early clinical effects of treatment with AP1189 in the context of COVID‐19.

Methods:

C57BL/6j mice were infected intranasally with MHV‐A59 or hK18‐ACE2 mice with SARS‐CoV‐2. AP1189 (10 mg·kg−1, BID, s.c.) was given to the animals from day 2 and parameters evaluated at day 5. Human PBMCs from health donors were infected with SARS‐CoV‐2 in presence or absence of AP1189 and production of cytokines quantified. In the clinical study, 6 patients were initially given AP1189 (100 mg daily for 14 days) and this was followed by a randomized (2:1), placebo‐controlled, double‐blind trial that enrolled 54 hospitalized COVID‐19 patients needing oxygen support. The primary outcome was the time in days until respiratory recovery, defined as a SpO2 ≥ 93% in ambient air.

Results:

Treatment with AP1189 attenuated pulmonary inflammation in mice infected with MHV‐A59 or SARS‐CoV‐2 and decreased the release of CXCL10, TNF‐α and IL‐1β by human PBMCs. Hospitalized COVID‐19 patients already taking glucocorticoids took a median time of 6 days until respiratory recovery when given placebo versus 4 days when taking AP1189 (P = 0.017).

Conclusion:

Treatment with AP1189 was associated with less disease caused by beta‐coronavirus infection both in mice and in humans. This is the first demonstration of the effects of a pro‐resolving molecule in the context of severe infection in humans.

01 Apr 2015·Journal of immunology (Baltimore, Md. : 1950)Q2 · MEDICINE

Biased Agonism as a Novel Strategy To Harness the Proresolving Properties of Melanocortin Receptors without Eliciting Melanogenic Effects

Q2 · MEDICINE

Article

Author: Gobbetti, Thomas ; Perretti, Mauro ; Jonassen, Thomas E N ; Montero-Melendez, Trinidad ; Cooray, Sadani N

Abstract:

There is a need for novel approaches to control pathologies with overexuberant inflammatory reactions. Targeting melanocortin (MC) receptors represents a promising therapy for obesity and chronic inflammation, but lack of selectivity and safety concerns limit development. A new way to increase selectivity of biological effects entails the identification of biased agonists. In this study, we characterize the small molecule AP1189 as a biased agonist at receptors MC1 and MC3. Although not provoking canonical cAMP generation, AP1189 addition to MC1 or MC3, but not empty vector, transfected HEK293 cells caused ERK1/2 phosphorylation, a signaling responsible for the proefferocytic effect evoked in mouse primary macrophages. Added to macrophage cultures, AP1189 reduced cytokine release, an effect reliant on both MC1 and MC3 as evident from the use of Mc1r−/− and Mc3r−/− macrophages. No melanogenesis was induced by AP1189 in B16-F10 melanocytes. In vivo, oral AP1189 elicited anti-inflammatory actions in peritonitis and, upon administration at the peak of inflammation, accelerated the resolution phase by ∼3-fold. Finally, given the clinical efficacy of adrenocorticotropin in joint diseases, AP1189 was tested in experimental inflammatory arthritis, where this biased agonist afforded significant reduction of macroscopic and histological parameters of joint disruption. These proof-of-concept analyses with AP1189, an active oral anti-inflammatory and resolution-promoting compound, indicate that biased agonism at MC receptors is an innovative, viable approach to yield novel anti-inflammatory molecules endowed with a more favorable safety profile.

News (Medical) associated with Resomelagon

03 Nov 2025

·www.synactpharma.com

Resomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion

SynAct Pharma AB (publ) (”SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnological company focused on treating inflammation through resolution therapy, has randomized 190 out of 240 patients and is on-track on lead program Phase 2b study. “Since summer we have established good momentum in recruitment,” said Thomas Jonassen, Chief Science Officer of SynAct Pharma. The Phase 2b ADVANCE is a 12-week randomized placebo-controlled study including newly diagnosed patients with Rheumatoid Arthritis, with elevated inflammation levels (CRP levels above 3mg/l), severe disease symptoms, and ready to initiate 1st line methotrexate therapy. Thomas Jonassen continues, “Rheumatoid Arthritis affects 18 million people and is expected to affect up to 32 million people by 2050 (ref. 1). About 50% of patients present with moderate to severe disease scores at time of diagnosis (ref. 2) and major medical societies recommend progressive treatment to prevent disease from progressing. Resomelagon in addition to 1st line methotrexate therapy may be a safe and effective way to reduce disease symptoms and may prolong or prevent the need for additional therapy typically adding glucocoid steriods and biologic DMARDS.” References: 1) Lancet Rheumatol 2023;5: e594–610; 2) Z Rheumatol. 2017 Jun;76(5):434-442 For further information, please contact:Jeppe ØvlesenCEO, SynAct Pharma ABPhone: + 45 2844 7567E-mail: investor.relations@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For further information: https://www.synactpharma.com/. AttachmentsResomelagon Phase-2B ADVANCE Study Update: 190 Patients Randomized Tracking for Year-End Recruitment Completion

Phase 2Clinical Result

31 Oct 2025

·www.synactpharma.com

SynAct Pharma Participating in Partnering and Investor Conference Bio-Europe® 2025

SynAct Pharma AB (publ) (”SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnological company focused on treating inflammation through resolution therapy, announced that the company will participate at the BioEurope meeting on November 3-4, 2025, in Vienna, Austria. This is a premier event with more than 5.700 delegates representing pharma, biotech, and investors. “BioEurope is one of the biggest platforms of the year for engaging with potential partners, and we are excited to engage in discussion on SynAct’s progress and path forward. Our lead program, Resomelagon, is a potential first-in-class non-suppressive immune modulation therapy that we are developing for rheumatoid arthritis and for host directed inflammation due to viral infections. Both applications have the potential of supporting millions of patients on an annual basis. We look forward to discussions with companies at BioEurope on potential collaborations,” said Mads Bjerregaard, Chief Business Officer of SynAct Pharma. Thomas Jonassen, Chief Science Officer and founder, and Mads Bjerregaard, Chief Business Officer, will be attending the meeting. BioEurope® 2025 is the premier event for life science with delegates from biotech, medtech, finance and research sectors. Over 5.700 delegates from more than 60 countries join a valuable program and over 30.000 partnering meetings is held over three days. For further information, please contact:Jeppe ØvlesenCEO, SynAct Pharma ABPhone: + 45 2844 7567E-mail: investor.relations@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For further information: https://www.synactpharma.com/. AttachmentsSynAct Pharma Participating in Partnering and Investor Conference Bio-Europe® 2025

Immunotherapy

04 Jun 2025

·www.synactpharma.com

SynAct Pharma Refines Development Strategy for Lead Compound Resomelagon (AP1189)

SynAct Pharma AB (“SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnology company focused on treating inflammation through resolution, today updates on the development strategy for the lead compound resomelagon (AP1189). The compound offers an opportunity to promote inflammatory resolution and a novel treatment approach in inflammatory diseases. Following internal prioritization and the prospect of external collaborations SynAct will focus on two parallel development tracks: 1) early intervention in autoimmune and inflammatory diseases with primary focus on rheumatoid Arthritis (RA) and 2) host-directed treatment in viral infections. The aim in both development tracks will be to bring the immune system to a new homeostatic setpoint or balance in conditions with activated immune system. A successful development will show the vast potential of the compound and expand the proof of concept beyond single diseases, allowing SynAct and potential partners to create value for both patients and investors in the program. In brief SynAct will execute the strategy as follows: Continue recruitment in the ADVANCE Ph2b study with the aim to have all patients dosed in 2025 Initiate a Phase 2a Proof concept study in Polymyalgia Rheumatica Conduct the RESOVIR-2 study in Dengue Continue preclinical evaluation of the pharmacological potential of resomelagon in viral infection to support the setup and a phase 2 clinical proof of concept study in patients developing respiratory insufficiency due to respiratory viral infections. Continue recruitment to the ongoing study in idiopathic membranous nephropathy “The refined development strategy for resomelagon optimizes the opportunity for commercial partnerships. Since the autumn we have succeeded on executing the ADVANCE phase 2b study with recruitment according to plan and setup and initiate the RESOVIR-2 study in dengue,” said CEO Jeppe Øvlesen. “We have also been able to secure additional funding to support execution of additional development tasks that reflects our belief and trust in resomelagon.” In the ongoing Ph2b ADVANCE study the compound is tested in newly diagnosed Rheumatoid Arthritis (RA) patients with high disease activity including sign of systemic inflammation. This study aimes to include 240 randomized RA patients at sites in US and Europe is running according to plan, meaning that it is expected that the last patients will complete dosing in Q4 2025. The potential of the compound in newly diagnosed RA patients is to be a safe and effective once daily oral dosing opportunity as alternative to glucocorticoid (GC) with the potential to postpone, or even reduce, the need for second line treatment as the biologics. As part of the continued development and to optimize the business opportunities for partnering, it is the intention to seek scientific and development advise from EMA and FDA for the Phase 3 development in H1 2026 in parallel with partnering discussions. Early intervention with resomelagon could potentially be applied in other autoimmune and inflammatory diseases. SynAct has therefore decided to enter into as clinical collaboration with leading Nordic rheumatologist with the aim to test the compound’s potential to reduce the use of GC in polymyalgia rheumatica (PMR), an inflammatory condition characterized by severe bilateral pain and morning stiffness of the shoulder, neck and pelvic girdle. PMR typically affects people that are middle aged to older and ranks at the second-most common rheumatic disease after RA in Northern Europe and North America. Consequently, a clinical trial application for a Phase 2a study, set up in a cost-effective way, will be filed in the near future. The current first line treatment in PMR is GCs given orally. To reduce the risk for GC induced side effects the recommendation in the current treatment guideline is to tamper GCs over a few weeks. GC discontinuation is associated with high risk for relapses. Consequently, early intervention with resomelagon could be a treatment option to reduce the use of GC, reduce the risk for relapses, and provide better disease control. The second track, host-directed treatment in viral infections, focuses on the compound’s ability to treat viral-induced hyperinflammatory responses through resomelagon’s unique ability to promote resolution. The development track is supported by: Outcome of the RESOVIR-1 study showing significantly faster recovery and shorter hospital stay relative to placebo following resomelagon treatment to patients with severe COVID-19 Recent preclinical studies showing significant disease modulating effects of resomelagon in virus infections including Dengue, Chikungunya and Influenza The clinical activity includes the RESOVIR-2 study where the compound is given to patients with Dengue to evaluate the potential of the drug to reduce disease activity measured by a composite clinical end point. The recent preclinical data support continued development of the compound in patients developing respiratory insufficiency due to respiratory viral infections. Respiratory insufficiency is a common reason to hospitalization following a number of virus infections including influenza, RS and COVID. Giving resomelagon as host-directed treatment to these patients to resolve inflammation has the potential to promote recovery and reduce the risk for further exacerbations. For further information, please contact:Jeppe ØvlesenCEO, SynAct Pharma ABPhone: + 45 2844 7567E-mail: investor.relations@synactpharma.com About SynAct Pharma ABSynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical stage biotechnology company focused on the resolution of inflammation through the selective activation of the melanocortin system. The company has a broad portfolio of oral and injectable selective melanocortin agonists aimed at inducing anti-inflammatory and inflammation resolution activity to help patients achieve immune balance and overcome their inflammation. For more information: https://www.synactpharma.com/. AttachmentsSynAct Pharma Refines Development Strategy for Lead Compound Resomelagon (AP1189)

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100 Deals associated with Resomelagon

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Indication	Highest Phase	Country/Location	Organization	Date
Inflammation	Phase 2	United States	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Bulgaria	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Denmark	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Moldova	SynAct Pharma ApS	01 Oct 2024
Inflammation	Phase 2	Poland	SynAct Pharma ApS	01 Oct 2024
Nephrotic Syndrome	Phase 2	Sweden	SynAct Pharma ApS	30 Jan 2022
Respiratory Distress Syndrome, Adult	Phase 2	Sweden	SynAct Pharma ApS	30 Jan 2022
Idiopathic Membranous Glomerulonephritis	Phase 2	Denmark	SynAct Pharma ApS	31 Aug 2020
Infantile multisystem neurologic-endocrine-pancreatic disease	Phase 2	Denmark	SynAct Pharma ApS	31 Aug 2020
Proteinuria	Phase 2	Denmark	SynAct Pharma ApS	31 Aug 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04004429 (BEGIN, CTgov)	Phase 2	Rheumatoid Arthritis	105	50 mg AP1189 (50 mg AP1189)	sedpddsonq = giiigdihvf vjejanzufu (egzmvyhjha, sobakurozv - xqxmsvxgwd) View more	-	10 Jul 2024
				AP1189 (100 mg AP1189)	sedpddsonq = bosahksdmq vjejanzufu (egzmvyhjha, pwtgzpygjz - ruklmfstre) View more
NCT05516979 (EXPAND，SynAct-CS007, NEWS 1 \| NEWS 2)	Phase 2	Rheumatoid Arthritis	55	Resomelagon	iwbhpaxrpl(arpijkxmgh) = vtxiguxuvq mqqgctffxh (rqthlxkszd ) View more	Positive	22 Feb 2024
				安慰剂	iwbhpaxrpl(arpijkxmgh) = rjfsksurzb mqqgctffxh (rqthlxkszd ) View more
NCT05516979 (EXPAND，SynAct-CS007, ACR2023 \| NEWS)	Phase 2	Rheumatoid Arthritis	127	Resomelagon	djvlviztia(hqbspprevb) = lpgmkbywdz kblreppbzj (eneweldidl )	Negative	04 Sep 2023
				安慰剂	djvlviztia(hqbspprevb) = ttynfscvuv kblreppbzj (eneweldidl )

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