Phase 2 RESOLVE-Lung Enrollment Complete for Namilumab in Pulmonary Sarcoidosis

Namilumab, a fully human monoclonal antibody, is currently under investigation for its potential to treat chronic pulmonary sarcoidosis by targeting granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine linked to inflammation in the disease. The RESOLVE-Lung trial, a Phase 2 study, has successfully completed enrollment with 107 participants suffering from sarcoidosis whose conditions are not adequately managed by existing treatments. The trial, which is double-blind and placebo-controlled, aims to assess the efficacy and safety of namilumab, which is administered once monthly via subcutaneous injection.
Sarcoidosis is an inflammatory disease that predominantly affects the lungs and can lead to severe complications if left untreated. Current therapies, including oral steroids and immunosuppressants, may not be effective for all patients and can have serious side effects. The RESOLVE-Lung study is expected to deliver preliminary findings by the end of 2024, which could be instrumental for the drug's registration process.
Kinevant Sciences, a clinical-stage biopharmaceutical company and a subsidiary of Roivant, is developing namilumab. The company is committed to creating therapies for rare inflammatory and autoimmune diseases, focusing on treatments that can fundamentally alter the disease course. The Foundation for Sarcoidosis Research has expressed its support for the trial and the potential new treatment, highlighting the need for better options for patients with sarcoidosis.
Namilumab has shown promise in non-clinical studies, where it has been observed to reduce granuloma activity and inflammation, which are hallmarks of sarcoidosis. The drug has also demonstrated a good safety profile in over 350 participants in various clinical trials. If successful, namilumab could become a groundbreaking therapy for pulmonary sarcoidosis, offering a well-tolerated and effective treatment option for patients.

The RESOLVE-Lung study is being conducted across multiple sites in the U.S. and Europe, with participants receiving either namilumab or a placebo for approximately six months. The primary outcome measure is the rate of rescue events due to disease worsening, while secondary endpoints include changes in lung function, patient-reported outcomes, steroid usage, and the drug's safety and tolerability. Participants who complete the double-blind phase are eligible for a 28-week open-label extension period.

Roivant, the parent company of Kinevant Sciences, is a biopharmaceutical firm focused on accelerating the development and commercialization of innovative medicines. Their pipeline includes a range of treatments for various conditions, from dermatological to autoimmune diseases. Roivant employs a subsidiary model to advance its drug candidates, fostering a patient-centric approach to drug development.