Roivant’s Kinevant Discontinues Namilumab Development for Pulmonary Sarcoidosis After Phase 2 Failure

Kinevant Sciences, a Roivant subsidiary, reported that its Phase 2 RESOLVE-Lung study of namilumab failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis13.

Namilumab is an investigational anti-GM-CSF monoclonal antibody that was being developed for the treatment of sarcoidosis13.

The primary endpoint of the RESOLVE-Lung study, which measured the proportion of subjects with a "rescue event," was not met1.

Secondary endpoints, including changes in forced vital capacity and corticosteroid tapering success, also failed to demonstrate benefit1.

As a result of the study's failure, Kinevant is discontinuing further development of namilumab for the treatment of sarcoidosis37.

The RESOLVE-Lung study enrolled 107 patients with chronic active pulmonary sarcoidosis17.

Roivant CEO Matt Gline acknowledged the failure but emphasized the importance of risk-taking in clinical development and the company's commitment to developing new medicines for patients in need13.

This setback follows other recent pipeline failures for Roivant, including the closure of Hemavant earlier in the year due to a failed midstage trial1.

Namilumab has a history of being tested for various indications, including rheumatoid arthritis and axial spondyloarthritis, with previous failures in efficacy1.

Despite this setback, Roivant continues to advance other pipeline programs, including IMVT-1402, batoclimab, brepocitinib, and mosliciguat for various indications3.

Sources:

1. https://www.fiercebiotech.com/biotech/roivant-spinout-ends-development-lung-disease-asset-after-phase-2-fail

3. https://investor.roivant.com/news-releases/news-release-details/roivant-announces-topline-results-phase-2-resolve-lung-study

7. https://www.globenewswire.com/news-release/2024/12/03/2990444/34323/en/Roivant-Announces-Topline-Results-from-Phase-2-RESOLVE-Lung-Study-of-Namilumab-in-Chronic-Active-Pulmonary-Sarcoidosis.html