Kinevant Sciences Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis

Secondary Endpoints Overview:
The secondary efficacy endpoints, which included changes in the percent predicted forced vital capacity, success in corticosteroid tapering, and improvements in the patient-reported King's Sarcoidosis Questionnaire, did not demonstrate a treatment benefit aligned with the primary endpoint.

Safety Overview:
The safety profile of namilumab in the RESOLVE-Lung trial remained consistent with findings from prior studies.

As a result of these outcomes, Kinevant has decided to discontinue the development of namilumab as a treatment for sarcoidosis. However, the company is committed to publishing the RESOLVE-Lung results to support future research in the field.

"While the RESOLVE-Lung trial did not show a treatment benefit for namilumab, the wealth of data generated by this study will be incredibly valuable to researchers dedicated to advancing sarcoidosis care," said Bill Gerhart, CEO of Kinevant. "I want to extend my deepest gratitude to the patients who courageously participated in this trial, as well as to the Kinevant team, our industry partners, principal investigators, site staff, and patient advocacy groups who all played critical roles in conducting this significant study."

"Taking risks in clinical development is a cornerstone of our industry and central to Roivant's mission of delivering new therapies to patients in need," said Matt Gline, CEO of Roivant. "The RESOLVE-Lung study was meticulously designed and provided clear insights into the potential of namilumab for this patient group. Unfortunately, science can be humbling, but we take pride in the attempt and in our successes across other programs this year. We remain committed to pursuing innovative and calculated opportunities in the future."