Roivant Sciences, a clinical-stage biopharmaceutical company, recently reported the topline results from its Phase 2 Resolve-Lung study of namilumab in chronic active pulmonary sarcoidosis. Unfortunately, the study did not show a treatment benefit for namilumab in patients with pulmonary sarcoidosis, leading to the decision to discontinue further development of the drug for this indication.
The study, which evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody, in participants with chronic active pulmonary sarcoidosis, revealed that namilumab failed to meet the primary endpoint of the proportion of subjects with a rescue event during the double-blind period. Additionally, the study's secondary efficacy endpoints, including change in percent predicted forced vital capacity, corticosteroid tapering success, and change in the patient-reported King’s Sarcoidosis Questionnaire, also failed to show a treatment benefit consistent with the primary endpoint.
It is worth noting that the safety profile of namilumab in the Resolve-Lung study remained similar to previous studies.
The Resolve-Lung study enrolled 107 patients with pulmonary sarcoidosis considered to have chronic, active disease not well-controlled despite available therapeutic options. The primary endpoint of the study was the proportion of subjects with a rescue event during the double-blind period, which was defined as clinically significant worsening of a subject’s sarcoidosis requiring treatment, failure to adhere to the protocol-defined oral corticosteroid taper, or premature discontinuation from the study associated with lack of benefit during the double-blind treatment period.
Pulmonary sarcoidosis is a lung disease characterized by the presence of granulomas of unknown etiology that can cause breathlessness, fatigue, and pain. The inflammation associated with the disease, if not effectively treated, can result in lung tissue scarring, lung dysfunction, and eventually lung failure. Approximately 200,000 people in the U.S. (and more than 1 million worldwide) are estimated to have sarcoidosis, with about 90% of cases involving the lung.
Namilumab, the drug under investigation, is an anti-GM-CSF monoclonal antibody being developed for the treatment of pulmonary sarcoidosis.
In light of the results, Kinevant Sciences, the company behind the development of namilumab, has decided to discontinue further development of the drug for the treatment of sarcoidosis. The company expressed its commitment to publishing the results of the Resolve-Lung study to inform future sarcoidosis research.
While the results of the study are disappointing, the company's CEO emphasized the significant amount of information produced by the study, which will be tremendously helpful to those in the field who are committed to improving the lives of sarcoidosis patients.
It's evident from the data that the Resolve-Lung study was thoughtfully designed and gave a clear read on the potential benefits of namilumab in this patient population. Although the study did not yield the desired outcome, the company remains committed to taking calculated risks on similar programs in the future. Following these announcements, the company's shares moved -2.6%, and are now trading at a price of $12.16. Check out the company's full 8-K submission here.
