Roivant Phase II miss for namilumab

Roivant Sciences (Nasdaq: ROIV) portfolio company Kinevant Sciences today revealed its Phase II study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis.

The Phase II 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.

Namilumab failed to meet the primary endpoint of proportion of subjects with a Rescue Event during the double-blind period. Additionally, the company noted that 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.