A Randomized, Double-blind, Placebo-Controlled Phase 2 Study With Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects With Chronic Pulmonary Sarcoidosis

This is a randomized, double-blind, placebo-controlled study with an open-label extension (OLE).

Start Date31 Aug 2022

Sponsor / Collaborator

Kinevant Sciences GmbH

NCT05351554

/ TerminatedPhase 2

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis

A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.

Start Date23 Aug 2022

Sponsor / Collaborator

Kinevant Sciences GmbH

NCT03622658

/ CompletedPhase 2

A Phase 2a Study to Evaluate the Safety and Efficacy of Namilumab in Subjects With Moderate-to-severely Active Axial Spondyloarthritis

The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or placebo.

Start Date06 Sep 2018

Sponsor / Collaborator

Izana Bioscience Ltd.

[+2]

100 Clinical Results associated with Namilumab

100 Translational Medicine associated with Namilumab

100 Patents (Medical) associated with Namilumab

Literatures (Medical) associated with Namilumab

01 Nov 2025·Contemporary Clinical Trials

Design of RESOLVE Lung, a multinational Phase 2, randomized, placebo-controlled trial of the anti-GM-CSF monoclonal antibody namilumab in patients with chronic pulmonary sarcoidosis

Article

Author: Lin, Min ; van den Blink, Bernt ; Birring, Surinder S ; Reiss, Theodore F ; Petit, Chantal M ; Baughman, Robert P ; Dansky, Hayes M ; Wijsenbeek-Lourens, Marlies S

BACKGROUND:

Pulmonary sarcoidosis is a rare inflammatory disease associated with morbidity and mortality. In light of limited treatment options, oral corticosteroids (OCS), off-label immunosuppressive therapies (IST) and tumor necrosis factor alpha inhibitors are standard of care. However, due to tolerability concerns with long-term use of OCS and IST, novel treatment options are needed. Namilumab is a potent, investigational granulocyte macrophage colony-stimulating factor humanized monoclonal antibody, that can potentially downregulate the granulomatous response, with favorable tolerability observed across clinical studies.

STUDY DESIGN:

In this double-blind, 26-week, placebo-controlled trial, with an optional 28-week, open-label extension, approximately 100 patients will be randomized in a 1:1 ratio to receive 150 mg namilumab or placebo via subcutaneous injection. Eligible patients have active, chronic pulmonary sarcoidosis (CPS; assessed by clinical and radiologic parameters) poorly regulated by OCS and/or ISTs or failed or intolerant to treatment. At randomization, ISTs will be stopped and OCS tapered.

OBJECTIVE:

The objective of this trial is to evaluate the efficacy and safety of namilumab in patients with active CPS. The primary endpoint is the proportion of patients requiring rescue treatment during the double-blind period due to worsening sarcoidosis. Secondary endpoints include assessment of lung function, respiratory symptoms, and corticosteroid burden. Additionally, quality-of-life assessments, serum biomarkers, and a composite clinical benefit endpoint will be explored.

DISCUSSION:

This study will be one of the largest Phase 2 trials in the last decade for active CPS. Data from this trial will potentially provide valuable insights into disease endpoints, patient selection, and optimizing trial design.

01 Aug 2024·Lancet Rheumatology

Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial

Article

Author: Gaffney, Karl ; Macdonald, Joanne ; Cook, Jonathan A ; Worth, Claudia ; Packham, Jonathan ; Corn, Tim H ; Gullick, Nicola ; Sengupta, Raj ; Machado, Pedro M ; Taylor, Peter C ; Chan, Antoni ; Bowness, Paul ; Al-Mossawi, M Hussein ; Teh, James ; Fisher, Benjamin A

BACKGROUND:

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a proinflammatory cytokine overproduced in several inflammatory and autoimmune diseases, including axial spondyloarthritis. Namilumab is a human IgG1 monoclonal anti-GM-CSF antibody that potently neutralises human GM-CSF. We aimed to assess the efficacy of namilumab in participants with moderate-to-severe active axial spondyloarthritis.

METHODS:

This proof-of-concept, randomised, double-blind, placebo-controlled, phase 2, Bayesian (NAMASTE) trial was done at nine hospitals in the UK. Participants aged 18-75 years with axial spondyloarthritis, meeting the Assessment in SpondyloArthritis international Society (ASAS) criteria and the ASAS-defined MRI criteria, with active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), were eligible. Those who had inadequately responded or had intolerance to previous treatment with an anti-TNF agent were included. Participants were randomly assigned (6:1) to receive subcutaneous namilumab 150 mg or placebo at weeks 0, 2, 6, and 10. Participants, site staff (except pharmacy staff), and central study staff were masked to treatment assignment. The primary endpoint was the proportion of participants who had an ASAS ≥20% improvement (ASAS20) clinical response at week 12 in the full analysis set (all randomly assigned participants). This trial is registered with ClinicalTrials.gov (NCT03622658).

FINDINGS:

From Sept 6, 2018, to July 25, 2019, 60 patients with moderate-to-severe active axial spondyloarthritis were assessed for eligibility and 42 were randomly assigned to receive namilumab (n=36) or placebo (n=six). The mean age of participants was 39·5 years (SD 13·3), 17 were women, 25 were men, 39 were White, and seven had previously received anti-TNF therapy. The primary endpoint was not met. At week 12, the proportion of patients who had an ASAS20 clinical response was lower in the namilumab group (14 of 36) than in the placebo group (three of six; estimated between-group difference 6·8%). The Bayesian posterior probability η was 0·72 (>0·927 suggests high clinical significance). The rates of any treatment-emergent adverse events in the namilumab group were similar to those in the placebo group (31 vs five).

INTERPRETATION:

Namilumab did not show efficacy compared with placebo in patients with active axial spondyloarthritis, but the treatment was generally well tolerated.

FUNDING:

Izana Bioscience, NIHR Oxford Biomedical Research Centre (BRC), NIHR Birmingham BRC, and Clinical Research Facility.

01 Mar 2022·The Lancet. Respiratory medicine

Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial

Article

Author: Porter, Joanna ; Whitehouse, Tony ; Parekh, Dhruv ; Gabriel, Zoe ; Newsome, Philip N ; Richards, Duncan ; Thickett, David R ; Scriven, James ; Veenith, Tonny ; Sharpe, Rowena ; Kearns, Pamela ; Ho, Ling-Pei ; Fisher, Benjamin A ; Slade, Daniel ; Gates, Simon ; McShane, Helen ; Cooke, Graham ; Rowland, Matthew ; Bion, Julian ; Rowe, Anna ; Balasubramaniam, Madhu S ; Gaskell, Charlotte ; Morley, Nick ; Wise, Matthew P

BACKGROUND:

Dysregulated inflammation is associated with poor outcomes in COVID-19. We aimed to assess the efficacy of namilumab (a granulocyte-macrophage colony stimulating factor inhibitor) and infliximab (a tumour necrosis factor inhibitor) in hospitalised patients with COVID-19, to prioritise agents for phase 3 trials.

METHODS:

In this randomised, multicentre, multi-arm, multistage, parallel-group, open-label, adaptive, phase 2, proof-of-concept trial (CATALYST), we recruited patients (aged ≥16 years) admitted to hospital with COVID-19 pneumonia and C-reactive protein (CRP) concentrations of 40 mg/L or greater, at nine hospitals in the UK. Participants were randomly assigned with equal probability to usual care or usual care plus a single intravenous dose of namilumab (150 mg) or infliximab (5 mg/kg). Randomisation was stratified by care location within the hospital (ward vs intensive care unit [ICU]). Patients and investigators were not masked to treatment allocation. The primary endpoint was improvement in inflammation, measured by CRP concentration over time, analysed using Bayesian multilevel models. This trial is now complete and is registered with ISRCTN, 40580903.

FINDINGS:

Between June 15, 2020, and Feb 18, 2021, we screened 299 patients and 146 were enrolled and randomly assigned to usual care (n=54), namilumab (n=57), or infliximab (n=35). For the primary outcome, 45 patients in the usual care group were compared with 52 in the namilumab group, and 29 in the usual care group were compared with 28 in the infliximab group. The probabilities that the interventions were superior to usual care alone in reducing CRP concentration over time were 97% for namilumab and 15% for infliximab; the point estimates for treatment-time interactions were -0·09 (95% CI -0·19 to 0·00) for namilumab and 0·06 (-0·05 to 0·17) for infliximab. 134 adverse events occurred in 30 (55%) of 55 patients in the namilumab group compared with 145 in 29 (54%) of 54 in the usual care group. 102 adverse events occurred in 20 (69%) of 29 patients in the infliximab group compared with 112 in 17 (50%) of 34 in the usual care group. Death occurred in six (11%) patients in the namilumab group compared with ten (19%) in the usual care group, and in four (14%) in the infliximab group compared with five (15%) in the usual care group.

INTERPRETATION:

Namilumab, but not infliximab, showed proof-of-concept evidence for reduction in inflammation-as measured by CRP concentration-in hospitalised patients with COVID-19 pneumonia. Namilumab should be prioritised for further investigation in COVID-19.

FUNDING:

Medical Research Council.

News (Medical) associated with Namilumab

10 Feb 2025

·investor.roivant.com

Roivant Reports Financial Results for the Third Quarter Ended December 31, 2024, and Provides Business Update

BASEL, Switzerland and LONDON and NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the third quarter ended December 31, 2024, and provided a business update. Brepocitinib to be developed in third indication, cutaneous sarcoidosis (CS), an orphan indication with high unmet need; Phase 2 study initiation expected in second quarter of calendar year with topline data in second half of calendar year 2026 IMVT-1402 development is rapidly progressing with six Investigational New Drug (IND) applications cleared and pivotal studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) initiated Batoclimab topline results from pivotal trial in myasthenia gravis (MG) and initial results from period 1 of trial in chronic inflammatory demyelinating polyneuropathy (CIDP) expected by March 31, 2025 Progress in ongoing LNP litigation, with the summary judgment phase in the Moderna case taking place across the second and third quarters of calendar year 2025 and a jury trial scheduled for September 2025 Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement “Roivant has broadened our clinical pipeline with the newly announced trial of brepocitinib in cutaneous sarcoidosis. As with dermatomyositis and non-infectious uveitis, brepocitinib has the potential to be a first-in-class agent for CS and expands the treatment options for patients suffering from an indication with high unmet need,” said Matt Gline, CEO of Roivant. “We also look forward to announcing multiple significant study outcomes this year including for batoclimab in MG, CIDP and TED, and for brepocitinib in dermatomyositis. 2025 is a year of harvest for Roivant.” Recent Developments Immunovant:In January 2025, Immunovant announced a $450 million private placement with participation from a U.S.-based healthcare focused investor, a large mutual fund complex, and Roivant, bringing Roivant’s basic ownership up to approximately 57%.Endocrinology ProgramImmunovant recently initiated the first potentially registrational trial of IMVT-1402 in adult participants with GD who are hyperthyroid despite antithyroid drug (ATD) treatment. This study builds on the batoclimab proof-of-concept data presented in 2024, which suggest the potential for deep IgG reduction in the treatment of GD for patients who are not well controlled on ATDs.Rheumatology ProgramImmunovant recently initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody (ACPA) positive difficult-to-treat rheumatoid arthritis. The trial includes IMVT-1402’s higher dose (600 mg) as recent in-class data suggest that deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor. Priovant: In February 2025, Priovant announced a Phase 2 study of the safety and efficacy of brepocitinib in adults with cutaneous sarcoidosis. Cutaneous sarcoidosis marks the third indication for brepocitinib and continues the strategy to develop the drug in orphan indications with high unmet need. There are 30,000 to 50,000 patients in the US affected by cutaneous sarcoidosis with no approved therapies. The trial is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026. Genevant: The Pfizer / BioNTech Markman hearing was held in December 2024. Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement.In December 2024, Roivant announced Kinevant’s Phase 2 study of namilumab failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. Kinevant is discontinuing further development of namilumab for the treatment of sarcoidosis. Major Upcoming Milestones Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026. Neurology ProgramImmunovant intends to report topline results from the pivotal trial of batoclimab in MG by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and inform the design of a potentially registrational program for IMVT-1402 in MG, which Immunovant expects to initiate following the disclosure of the batoclimab data in MG.Results from period one of the trial evaluating batoclimab in CIDP continue to be expected by March 31, 2025. Those results, as well as observations drawn from public disclosures of other studies in CIDP, are expected to inform a potentially registrational program for IMVT-1402 in CIDP, which Immunovant expects to initiate following the disclosure of the batoclimab CIDP data.Endocrinology ProgramImmunovant plans to announce additional data from the batoclimab proof-of-concept study in GD including 6-month, treatment-free remission data designed to further articulate potential for IMVT-1402 in GD. These data are expected in the summer of 2025.Topline results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves' ophthalmopathy, continue to be expected in the second half of calendar year 2025, along with a decision whether to pursue marketing authorization for batoclimab in TED. Data from this trial may also inform the IMVT-1402 program in GD. Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of calendar year 2027.Priovant’s Phase 2 trial of brepocitinib in cutaneous sarcoidosis is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026. Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of calendar year 2026. Genevant litigation against Moderna continues to progress with summary judgment phase scheduled for second and third quarter of calendar year 2025; Moderna jury trial scheduled for September 2025. Third Quarter Ended December 31, 2024 Financial Summary Cash Position and Marketable Securities As of December 31, 2024, the Company had consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $5.2 billion. Research and Development Expenses Research and development (R&D) expenses increased by $33.4 million to $141.6 million for the three months ended December 31, 2024, compared to $108.1 million for the three months ended December 31, 2023. This increase was primarily driven by increases in program-specific costs of $26.2 million, personnel-related expenses of $3.9 million, and share-based compensation of $2.8 million. Within program-specific costs, the increase of $26.2 million was primarily driven by an increase in expense of $29.1 million related to the anti-FcRn franchise, partially offset by a decrease in expense of $5.7 million related to RVT-3101, which was sold to Roche in December 2023. Non-GAAP R&D expenses were $131.2 million for the three months ended December 31, 2024, compared to $100.2 million for the three months ended December 31, 2023. General and Administrative Expenses General and administrative (G&A) expenses increased by $13.4 million to $141.5 million for the three months ended December 31, 2024, compared to $128.2 million for the three months ended December 31, 2023. This increase largely resulted from an increase in share-based compensation expense of $25.0 million, primarily due to the long-term equity incentive awards granted in July 2024 pursuant to the 2024 Senior Executive Compensation Program. This increase was partially offset by a decrease in personnel-related expenses of $15.9 million, primarily due to higher expense in the three months ended December 31, 2023 related to a special one-time cash retention bonus award granted to employees, following approval in December 2023. Non-GAAP G&A expenses were $71.1 million for the three months ended December 31, 2024, compared to $82.6 million for the three months ended December 31, 2023. Income (loss) from discontinued operations, net of tax Income from discontinued operations, net of tax was $327.0 million for the three months ended December 31, 2024 and reflects the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Loss from discontinued operations, net of tax was $58.5 million for the three months ended December 31, 2023, representing the financial results of Dermavant during this period. (Loss) income from continuing operations, net of tax Loss from continuing operations, net of tax was $208.9 million for the three months ended December 31, 2024, compared to income from continuing operations, net of tax of approximately $5.1 billion for the three months ended December 31, 2023. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.22 for the three months ended December 31, 2024. On a basic and diluted per common share basis, income from continuing operations, net of tax was $6.44 and $6.10, respectively, for the three months ended December 31, 2023. Non-GAAP loss from continuing operations, net of tax was $143.7 million for the three months ended December 31, 2024, compared to $138.0 million for the three months ended December 31, 2023. Notes to non-GAAP financial measures: (1) Represents non-cash share-based compensation expense. (2) Represents non-cash depreciation and amortization expense. (3) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023 and a gain on the achievement of a one-time milestone in June 2024. (4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. (5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (6) Represents the one-time gain on deconsolidation of subsidiaries. (7) Represents the estimated tax effect of the adjustments. Investor Conference Call InformationRoivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, February 10, 2025, to report its financial results for the third quarter ended December 31, 2024, and provide a corporate update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About RoivantRoivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur Parekhkeyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com Print Page Email Alerts RSS Feeds IR Contacts

Phase 2Phase 3Financial StatementPhase 1Clinical Result

04 Dec 2024

·www.globenewswire.com

Roivant Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis

Namilumab failed to show treatment benefit in patients with pulmonary sarcoidosis Further development of namilumab for the treatment of sarcoidosis will be discontinued Dec. 03, 2024 -- Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered once-monthly as a subcutaneous injection, in participants with chronic active pulmonary sarcoidosis. Primary Endpoint Details: Namilumab failed to meet the primary endpoint of proportion of subjects with a Rescue Event during the double-blind period. Secondary Endpoints Details: Secondary efficacy endpoints, including change in percent predicted forced vital capacity, corticosteroid tapering success, and change in the patient reported King’s Sarcoidosis Questionnaire failed to show a treatment benefit consistent with the primary endpoint. Safety Details: The safety profile of namilumab in RESOLVE-Lung remains similar to previous studies. With these results, Kinevant will be discontinuing further development of namilumab for the treatment of sarcoidosis. Kinevant is committed to publishing the results of RESOLVE-Lung to inform future sarcoidosis research. “Although RESOLVE-Lung failed to show a treatment benefit for namilumab, the significant amount of information produced by the study will be tremendously helpful to those in the field who are committed to improving the lives of sarcoidosis patients,” said Bill Gerhart, CEO of Kinevant. “I would like to thank all the patients who courageously volunteered to participate in the study, as well as the Kinevant team, industry partners, principal investigators, site staff, and patient advocacy groups who all worked together to successfully conduct this important study for sarcoidosis.” “Risk-taking in clinical development is at the heart of our industry, and core to Roivant’s mission of developing new medicines for patients in need. It’s evident from our data that the RESOLVE-Lung study was thoughtfully designed and gave us a clear read on the potential benefits of namilumab in this patient population,” said Matt Gline, CEO of Roivant. “Unfortunately science is sometimes humbling, and we are proud to have made the attempt, as well as of our successes in other programs this year. We look forward to taking calculated risks on similar programs in the future.” The RESOLVE-Lung study is a Phase 2 randomized, double-blind, placebo-controlled study of namilumab for the treatment of pulmonary sarcoidosis at sites in the U.S. and Europe. The study enrolled 107 patients with pulmonary sarcoidosis considered to have chronic, active disease not well-controlled despite available therapeutic options. Patients in the study received a once-monthly subcutaneous injection of namilumab or placebo (following the initial dosing period) for approximately six months. All patients who complete the 26-week double-blind treatment period were eligible to participate in a 28-week open-label extension treatment period on namilumab. The primary endpoint of this study was proportion of subjects with a Rescue Event during the double-blind period. Rescue Event was defined as clinically significant worsening of a subject’s sarcoidosis requiring treatment, failure to adhere to the protocol defined OCS taper, or premature discontinuation from the study associated with lack of benefit during the double-blind treatment period. Study eligibility did not require subjects to be on high dose corticosteroids. If subjects were on >5mg/day of oral corticosteroid (OCS) at baseline, they were required to taper down to 5mg/day 8-10 weeks after randomization. If patients were on an immunosuppressive therapy (IST), they were required to stop the IST at randomization. Notably, all subjects enrolled had evidence of active pulmonary sarcoidosis disease, defined as a positive HRCT scan, significant lung inflammation on PET, and moderate to severe self-reported breathlessness. Pulmonary sarcoidosis is a lung disease characterized by the presence of granulomas (clumps of immune cells) of unknown etiology that can cause breathlessness, fatigue, and pain. The resulting inflammation, if not effectively treated, can result in lung tissue scarring (fibrosis), lung dysfunction, and eventually lung failure. Approximately 50% of diagnosed patients require chronic therapy to treat symptoms and prevent progression. Oral steroids (e.g., prednisone) and off-label immunosuppressive therapies (e.g., methotrexate) are first- and second-line therapies respectively for sarcoidosis; however, these therapeutic options are often not effective or can be accompanied by serious side effects. Approximately 200,000 people in the U.S. (and more than 1 million worldwide) are estimated to have sarcoidosis, an immune-mediated inflammatory disease that can affect any organ in the body, with about 90% of cases involving the lung. Granulocyte macrophage colony stimulating factor (GM-CSF) is a pro-inflammatory cytokine over-expressed in several inflammatory diseases, including sarcoidosis. GM-CSF mediated pro-inflammatory signaling is thought to play a central role in recruitment of macrophages and monocytes to the lung and to trigger a granulomatous response, including the fusion of macrophages into multinucleated giant cells. Namilumab is an anti-GM-CSF monoclonal antibody formulated to be administered once-monthly as a subcutaneous injection being investigated for the treatment of pulmonary sarcoidosis. Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis and non-infectious uveitis; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

04 Dec 2024

·pharma.economictimes.indiatimes.com

Roivant to stop lung disease drug development after trial failure

By Christy Santhosh Bengaluru: Roivant will discontinue the development of its drug for a rare lung disease after it failed to show treatment benefits in patients in a mid-stage trial. Shares of the company fell 4% in early trading after Roivant's unit, Kinevant Sciences , said on Tuesday its once-monthly injectable drug, namilumab, failed to meet the main and secondary goals of a 6-month trial evaluating it in 107 patients with chronic active pulmonary sarcoidosis . Leerink analyst David Risinger said the trial failure was "immaterial", adding that the company had previously described the development program to have a high risk-reward ratio. "We believe the Street's expectations for success were low," said Risinger. Chronic active pulmonary sarcoidosis causes lumps of inflammatory cells to form in the lungs and other organs, leading to tissue damage and organ dysfunction. Current treatments for the disease are corticosteroids and other immunosuppressants that only suppress the symptoms, which include shortness of breath, chest pain and persistent dry cough. "Unfortunately science is sometimes humbling, and we are proud to have made the attempt," Roivant CEO Matt Gline said in a statement. Sarcoidosis affects 150,000 to 200,000 people in the United States per year, according to the American Lung Association. Drug developer aTyr Pharma's efzofitimod is also being tested for the treatment of pulmonary sarcoidosis and is in late-stage development. (Reporting by Christy Santhosh in Bengaluru; Editing by Shinjini Ganguli)

Clinical StudyAHA

100 Deals associated with Namilumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Namilumab	-	DB13037

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sarcoidosis, Pulmonary	Phase 2	United States	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	Belgium	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	France	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	Germany	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	Netherlands	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	Turkey	Kinevant Sciences GmbH	31 Aug 2022
Sarcoidosis, Pulmonary	Phase 2	United Kingdom	Kinevant Sciences GmbH	31 Aug 2022
Cardiac sarcoidosis	Phase 2	United States	Kinevant Sciences GmbH	23 Aug 2022
Axial Spondyloarthritis	Phase 2	United Kingdom	Izana Bioscience Ltd.	06 Sep 2018
Ankylosing Spondylitis	Phase 2	United Kingdom	Izana Bioscience Ltd.	08 Aug 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05314517 (RESOLVE-Lung, CTgov)	Phase 2	Sarcoidosis, Pulmonary	107	Namilumab (Namilumab)	zmysawdegj = vustkfubvf bhvwhwadys (sioqbonjla, hhshmprnch - radygtghbr) View more	-	12 Sep 2025
				placebo+namilumab (Placebo)	zmysawdegj = ymyhwfujza bhvwhwadys (sioqbonjla, utknaedyba - xvduuslyem) View more
NCT05351554 (RESOLVE-Heart, CTgov)	Phase 2	Cardiac sarcoidosis	1	Namilumab	hbkmrlivpz = ijuebynfra tuuqsoymbr (mbpekfnaii, avtejdmdcg - dsggdugkxk) View more	-	17 Apr 2025
NCT05314517 (RESOLVE-Lung, GlobeNewswire) Manual	Phase 2	Sarcoidosis, Pulmonary	107	Namilumab	dcigesdjxb(pvkkzxddry) = Namilumab failed to meet the primary endpoint of proportion of subjects with a Rescue Event during the double-blind period. irnabxcswx (vulxkqqvoz ) Not Met	Negative	03 Dec 2024
				Placebo
NCT03622658 (NAMASTE, Pubmed) Manual	Phase 2	Axial Spondyloarthritis	42	Namilumab 150 mg	nqabbgzkck(ahmjjumdko) = ouulvjsikc gkgemqmspk (adbhutffcy ) Not Met View more	Negative	25 Jun 2024
				Placebo	nqabbgzkck(ahmjjumdko) = tgemtsjjuk gkgemqmspk (adbhutffcy ) Not Met View more
NCT03622658 (NAMASTE, CTgov)	Phase 2	Axial Spondyloarthritis	42	Placebo (Placebo)	hhyrrzpfkc = uevqiizqxt kuhomgqcay (untkpeletc, xtksxrgoqg - iodcqkujii) View more	-	08 Mar 2022
				Namilumab (Namilumab)	hhyrrzpfkc = vwfpgwtedr kuhomgqcay (untkpeletc, uuhztniqhd - vqkcgvmbjo) View more
NCT02129777 (NEPTUNE, Pubmed \| Br J Dermatol) Manual	Phase 2	Psoriasis	122	namilumab	hmzkmdqsgq(fedmpqgmsn) = The number of patients showing PASI 75 treatment response at week 12 was low in all groups. mxkewktlaa (klatgkeoll )	Negative	01 Jun 2019
				Placebo
NCT02354599 (Pubmed \| Int J Clin Pharmacol Ther) Manual	Phase 1	-	32	namilumab (Japanese subjects)	akdzqwvvuc(qialewdepe) = no discontinuation Serious Adverse Event cdlqppbyxk (szygvnzftf ) View more	Positive	01 Nov 2018
				namilumab (Caucasian subjects)
NCT02379091 (NEXUS, CTgov)	Phase 2	Rheumatoid Arthritis	108	Placebo+Folic+folinic acid+Methotrexate (Placebo)	yilzvrcrrr(owcmltrnmr) = ambdrngrjc spxugsqipn (ygevoaupdv, 0.294) View more	-	14 Sep 2018
				Folic+folinic acid+Methotrexate+Namilumab (Namilumab 20 mg/mL)	yilzvrcrrr(owcmltrnmr) = hktipwjbff spxugsqipn (ygevoaupdv, 0.288) View more
NCT01317797 (PRIORA, Pubmed \| Arthritis Res Ther)	Phase 1	Rheumatoid Arthritis	21	Namilumab 150 mg	dcdcukiegg(qnsnixnkde) = cxommmrobr pvtmqodsug (jgqxyoorws )	-	01 Dec 2017
				Namilumab 300 mg	dcdcukiegg(qnsnixnkde) = bqzurnkwbk pvtmqodsug (jgqxyoorws )
NCT02354599 (CTgov)	Phase 1	-	32	MT203 80 mg or matching Placebo (Cohort 1: MT203 80 mg)	pyveykkxqh = crsbzmyobu jswwrcaiom (mgafpqdjhj, dfqpnxwjeg - gzgoayhrmb) View more	-	20 Jun 2016
				MT203 150mg or matching Placebo (Cohort 2: MT203 150 mg)	pyveykkxqh = rnzljplvas jswwrcaiom (mgafpqdjhj, wllxzkbyct - twgpklqemh) View more

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