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Worldwide Clinical Trials - Oncology

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

Friday, April 26, 2024

Roivant (Nasdaq: ROIV) and Kinevant Sciences have recently announced the successful completion of enrollment in their Phase 2 study assessing namilumab's efficacy in treating chronic pulmonary sarcoidosis (RESOLVE-Lung). Sarcoidosis affects approximately 200,000 individuals in the U.S. and over 1 million globally, with the lungs being involved in about 90% of cases. Namilumab, a potent anti-GM-CSF monoclonal antibody, is administered once-monthly as a subcutaneous injection and holds promise as a potential first disease-modifying therapy for sarcoidosis.

The RESOLVE-Lung trial is a randomized, double-blind, placebo-controlled study aiming to enroll at least 100 pulmonary sarcoidosis patients with poorly controlled disease despite existing treatment options. Bill Gerhart, CEO of Kinevant, emphasized the critical need for novel therapies for pulmonary sarcoidosis, acknowledging the significance of completing enrollment in this study. The company aims to release topline results by year-end.

Pulmonary sarcoidosis, characterized by immune cell clumps known as granulomas, can lead to breathlessness, fatigue, and pain, with potential complications such as lung tissue scarring and dysfunction. Current therapies, including oral steroids and immunosuppressive drugs, often come with significant side effects and may not effectively manage symptoms.

Namilumab targets GM-CSF, a cytokine implicated in granuloma formation and inflammation in sarcoidosis. By inhibiting GM-CSF, namilumab has demonstrated safety and tolerability in prior clinical trials, offering hope for an effective and well-tolerated treatment option. Mary McGowan, CEO of the Foundation for Sarcoidosis Research, highlighted the importance of developing new therapies and expressed gratitude to the patient community for their participation in the trial.

The RESOLVE-Lung trial, conducted at multiple sites in the U.S. and Europe, has enrolled 107 patients, and the primary endpoint is the difference in the proportion of patients experiencing worsening of their condition requiring rescue treatment. Secondary endpoints include changes in lung function, patient-reported outcomes, and safety. Following the initial 26-week blinded treatment period, patients have the option to participate in a 28-week open-label extension period on namilumab.



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