“Roivant Sciences Ltd. Reports Negative Results from Phase 2 RESOLVE-Lung Study on Namilumab for Pulmonary Sarcoidosis Treatment”

Roivant Sciences Ltd. recently disclosed the outcomes of the Phase 2 RESOLVE-Lung study conducted by Kinevant Sciences, regarding the effectiveness of namilumab in treating chronic active pulmonary sarcoidosis. The study results did not show significant treatment benefits for patients with this condition.

As per the press release issued on December 3, 2024, namilumab, an investigational anti-GM-CSF monoclonal antibody, did not meet the primary endpoint of the study, which was the proportion of subjects exhibiting a Rescue Event during the double-blind period. Secondary efficacy endpoints, including other measured parameters, also did not demonstrate treatment benefits matching the primary endpoint.

Despite maintaining a safety profile similar to previous studies, the lack of favorable outcomes has led to the decision to discontinue further development of namilumab for the treatment of sarcoidosis. Kinevant expressed its commitment to publishing the study results to contribute to future research in sarcoidosis.

In response to the results, Bill Gerhart, CEO of Kinevant, expressed gratitude to all participants involved in the study and emphasized the importance of the data generated for the advancement of sarcoidosis treatment. Matt Gline, CEO of Roivant, acknowledged the study’s design and the insights gained, illustrating the company’s dedication to advancing medical solutions for patients in need.

The Phase 2 RESOLVE-Lung study was a randomized, double-blind, placebo-controlled trial that enrolled patients with chronic, active pulmonary sarcoidosis. Despite the disappointing outcome, the data produced from the study is expected to provide valuable information for the medical community working towards enhancing treatment options for sarcoidosis patients.

Pulmonary sarcoidosis affects lung functionality and can lead to lung failure if untreated. Common therapies include steroids and immunosuppressive treatments; however, these options are not always effective and can have adverse effects.

Roivant Sciences continues to be actively involved in the development and commercialization of various medicines addressing autoimmune disorders and inflammatory diseases, besides conducting clinical trials to explore new therapeutic avenues for various medical conditions.

The company, acknowledging the challenges in the field of medical research, stands by its commitment to advancing patient care and remains optimistic about future endeavors despite the setbacks faced during the RESOLVE-Lung study.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Roivant Sciences’s 8K filing here.

About Roivant Sciences

Roivant Sciences Ltd., a commercial-stage biopharmaceutical company, engages in the development and commercialization of medicines for inflammation and immunology areas. The company provides Vants, a model to develop and commercialize its medicines and technologies focusing on biopharmaceutical businesses, discovery-stage companies, and health technology startups.