Roivant and Kinevant Sciences Complete Enrollment in RESOLVE-Lung, a Phase 2 Study Evaluating Namilumab for Chronic Pulmonary Sarcoidosis

Rhea-AI Summary

Roivant and Kinevant Sciences have completed enrollment in the RESOLVE-Lung Phase 2 study evaluating namilumab for chronic pulmonary sarcoidosis. Namilumab inhibits GM-CSF to target the underlying cause of the disease. The topline results are expected by the end of 2024. Sarcoidosis affects millions globally, and this study aims to provide a new treatment option for patients.

Insights

Medical Research Analyst

Namilumab is a therapeutic with significant potential for pulmonary sarcoidosis, a condition with limited effective treatments. By targeting GM-CSF, a cytokine implicated in inflammation and disease progression, the medication could fill a treatment void. For investors, the successful enrollment completion signals the company's ability to execute its clinical roadmap, which is key for maintaining investor confidence, especially in the biotech sector where clinical outcomes are critical.

As we look ahead to the topline results anticipated by the end of 2024, we should consider the market size and unmet need in this therapeutic area. Given the prevalence of sarcoidosis—200,000 in the U.S. and a larger global population—the addressable market could be substantial for Roivant and Kinevant Sciences, pending successful trial outcomes and eventual approval.

However, investors should be mindful of the inherent risks in biotech investing, particularly in clinical-stage companies. Delays, unexpected negative results, or regulatory hurdles could impact the company's valuation. It's important for investors to monitor the progression of the study and to be aware of the competitive landscape, as other treatments in development could affect the potential market share.

Financial Analyst

The announcement of completed enrollment in the RESOLVE-Lung study represents a milestone that's likely been factored into the valuation models for Roivant. Historically, biotech firms often see a rise in investor interest and share value as they make progress in their clinical trials. Keeping an eye on the company's burn rate and cash on hand is essential, as clinical studies are expensive undertakings that can quickly consume resources. We should also consider potential future financing needs or partnership deals, which could dilute existing shareholders but also bring additional expertise and resources.

In the run-up to releasing topline results, volatility is expected as investors speculate on the outcomes. A positive result could significantly uplift the company's stock, whereas failure could lead to a sharp decline. Diversification within an investment portfolio is one way to manage these risks. As with any clinical-stage biotech company, the potential reward must be weighed against the risk and investors should be prepared for all outcomes.

• Namilumab is a fully human monoclonal antibody that inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a pro-inflammatory cytokine believed to play a key role in the pathogenesis of sarcoidosis
• RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to be supportive of registration that enrolled 107 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatments
• Topline results are expected by the end of calendar year 2024

BASEL, Switzerland & LONDON & NEW YORK--(BUSINESS WIRE)-- Roivant (Nasdaq: ROIV) and Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced the successful completion of enrollment in its Phase 2 study evaluating namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung). 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. Namilumab is a potent anti-GM-CSF monoclonal antibody formulated to be conveniently administered once-monthly as a subcutaneous injection that has the potential to be the first disease-modifying therapy for sarcoidosis. Potentially supportive of registration, RESOLVE-Lung is a randomized, double-blind, placebo-controlled Phase 2 study designed to enroll a minimum of 100 pulmonary sarcoidosis patients whose disease is not well-controlled despite currently available treatment options.

“People living with pulmonary sarcoidosis clearly need new therapeutic options that can more safely and effectively control or resolve their disease,” said Bill Gerhart, CEO of Kinevant. “Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis. I am grateful for the patients who volunteered to participate in the study, as well as for the extraordinary efforts of the Kinevant team, our industry partners, clinical trial site staff, and patient advocacy groups, all of whom came together to overcome the unique challenges of this disease to successfully enroll this study. We are very hopeful about the outcome, and we look forward to reporting topline results by the end of the year.”

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.

Evidence from non-clinical studies indicate that GM-CSF is a key cytokine driving granuloma formation and inflammation in sarcoidosis, and that inhibiting GM-CSF can reduce granuloma activity and the resulting inflammation, leading potentially to a reduction in symptoms and resolution of the underlying disease. Namilumab is a potent inhibitor of GM-CSF that has been observed to be generally safe and well-tolerated in more than 350 participants across multiple clinical trials. Thus, namilumab has the potential to be the only well-tolerated and effective therapy for sarcoidosis, as well as the first therapy approved specifically for pulmonary sarcoidosis.

“Pulmonary sarcoidosis is a complex and challenging condition, with limited treatment options, and many unacceptable side effects. There is a need for new and better therapies to be developed,” said Mary McGowan, CEO of the Foundation for Sarcoidosis Research. “We are proud to have worked with Kinevant on the successful enrollment of this clinical trial. We are grateful to the sarcoidosis patient community who embraced this opportunity to lead us toward a potential new therapy as well as a deeper understanding of sarcoidosis.”

About RESOLVE-Lung

The RESOLVE-Lung study is a Phase 2 randomized, double-blind, placebo-controlled study of namilumab for the treatment of pulmonary sarcoidosis being conducted at multiple sites in the U.S. and Europe. The study has enrolled 107 pulmonary sarcoidosis patients considered not well-controlled despite available therapeutic options. Patients in the study receive a once-monthly subcutaneous injection of namilumab or placebo (following the initial dosing period) for approximately six months. The goal of the study is to assess the efficacy and safety of namilumab in patients with pulmonary sarcoidosis during the 6-month blinded treatment period. The primary endpoint is the difference in the proportion of patients with a rescue event due to worsening of their pulmonary sarcoidosis. Secondary endpoints include changes in pulmonary function, patient reported outcomes, steroid use, safety, and tolerability. All patients who complete the 26-week double-blind treatment period are eligible to participate in a 28-week open-label extension treatment period on namilumab. More information can be found at www.sarcoidosistrial.com.

About Namilumab

Namilumab is an investigational, fully human monoclonal antibody formulated to be conveniently administered once a month as a subcutaneous injection. Namilumab is a potent GM-CSF inhibitor that has been well-tolerated so far in more than 350 participants across multiple clinical trials. Evidence from non-clinical studies indicate that GM-CSF promotes macrophage and dendritic cell activity which contributes to granuloma formation. Inhibiting GM-CSF can reduce the presence of granulomas and the resulting inflammation, potentially leading to a reduction in symptoms and resolution of the underlying disease.

About Kinevant Sciences

Kinevant Sciences, a subsidiary of Roivant, is a clinical-stage biopharmaceutical company developing new medicines for rare autoimmune and inflammatory diseases. The company takes a patient-first approach to drug development, advancing candidates with the potential to resolve the underlying disease and create life-changing benefit for patients. Kinevant is initially focused on the development of namilumab for the treatment of sarcoidosis, a multi-organ systemic disease with a high unmet medical need. For more information, visit www.kinevant.com or follow us on LinkedIn.

About Roivant

Roivant is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Today, Roivant’s pipeline includes VTAMA®, a novel topical approved for the treatment of psoriasis and in development for the treatment of atopic dermatitis; batoclimab and IMVT-1402, fully human monoclonal antibodies targeting the neonatal Fc receptor (“FcRn”) in development across several IgG-mediated autoimmune indications; brepocitinib, a novel TYK2/JAK1 inhibitor in late stage development for dermatomyositis, non-infectious uveitis, and other autoimmune conditions, in addition to other clinical stage molecules. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240425073956/en/

Jennifer Arcure

Senior Vice President

Inizio Evoke Comms

Jennifer.Arcure@inizioevoke.com

Source: Kinevant Sciences

FAQ

What is the Phase 2 study by Roivant and Kinevant Sciences about?

The Phase 2 study by Roivant and Kinevant Sciences is evaluating namilumab for chronic pulmonary sarcoidosis.

What is namilumab and what does it target?

Namilumab is a fully human monoclonal antibody that inhibits GM-CSF, targeting the underlying cause of sarcoidosis.

How many patients were enrolled in the RESOLVE-Lung study?

The RESOLVE-Lung study enrolled 107 pulmonary sarcoidosis patients.

When are the topline results expected?

The topline results are expected by the end of calendar year 2024.

How many people are estimated to have sarcoidosis in the U.S.?

Approximately 200,000 people in the U.S. are estimated to have sarcoidosis.