Kinevant Sciences Reports Phase 2 RESOLVE-Lung Study Results for Namilumab in Chronic Pulmonary Sarcoidosis

BASEL, Switzerland and LONDON, UK and NEW YORK, NY, USA, December 03, 2024 - Kinevant Sciences, a biopharmaceutical company focused on developing innovative treatments for rare inflammatory and autoimmune disorders, has announced the results of its Phase 2 study, which unfortunately did not demonstrate any treatment benefit for patients suffering from chronic active pulmonary sarcoidosis. The study, named RESOLVE-Lung (NCT05314517), aimed to evaluate the efficacy and safety of namilumab, a monoclonal antibody targeting GM-CSF, administered once monthly via subcutaneous injection.

Key Details of the Study:
The study’s primary endpoint was the proportion of subjects who experienced a Rescue Event during the double-blind phase. Unfortunately, the results indicated that namilumab did not meet this primary endpoint. Furthermore, secondary endpoints, such as changes in predicted forced vital capacity, success in tapering corticosteroids, and patient-reported outcomes using the King’s Sarcoidosis Questionnaire, also failed to show a consistent treatment benefit.

Safety Profile:
Despite the lack of efficacy, the safety profile of namilumab in the RESOLVE-Lung study remained consistent with previous research findings. There were no new safety concerns reported.

Future Steps:
Due to these results, Kinevant has decided to discontinue the development of namilumab for treating sarcoidosis. However, the company remains committed to publishing the study's results to aid future sarcoidosis research endeavors. Bill Gerhart, CEO of Kinevant, emphasized the value of the data collected, noting that it would be invaluable to researchers dedicated to improving the lives of sarcoidosis patients. He also expressed gratitude to the patients, the Kinevant team, industry partners, principal investigators, site staff, and patient advocacy groups who contributed to the study.

Roivant’s Perspective:
Matt Gline, CEO of Roivant, highlighted the inherent risks in clinical development and reiterated Roivant’s mission to develop new treatments for patients in need. While the study did not achieve the desired outcomes, Gline acknowledged the thoughtful design of the RESOLVE-Lung study and its role in providing a clear understanding of namilumab’s potential in this patient population.

Study Design:
The RESOLVE-Lung study was a Phase 2 randomized, double-blind, placebo-controlled trial conducted at various sites across the U.S. and Europe. It involved 107 patients with chronic, active pulmonary sarcoidosis not well-controlled by existing treatments. Participants received a monthly subcutaneous injection of namilumab or placebo over approximately six months. Those who completed the 26-week double-blind period were eligible for a 28-week open-label extension on namilumab.

The primary endpoint was the proportion of subjects who experienced a Rescue Event, defined by clinically significant worsening of sarcoidosis, failure to adhere to corticosteroid tapering, or early study discontinuation due to lack of benefit. Participants were not required to be on high-dose corticosteroids, but those on more than 5mg/day of oral corticosteroids at baseline had to taper down after randomization. Subjects on immunosuppressive therapy (IST) were required to discontinue IST at randomization. All participants had evidence of active pulmonary sarcoidosis, confirmed by HRCT scans, PET scans showing significant lung inflammation, and moderate to severe self-reported breathlessness.

Understanding Pulmonary Sarcoidosis:
Pulmonary sarcoidosis is a lung condition marked by the presence of granulomas, which are clusters of immune cells that cause breathlessness, fatigue, and pain. If untreated, the resulting inflammation can lead to lung tissue scarring, dysfunction, and eventually lung failure. Approximately half of the diagnosed patients need ongoing treatment to manage symptoms and prevent disease progression. Standard treatments include oral steroids and off-label immunosuppressive drugs, though these often come with significant side effects.

The disease affects roughly 200,000 people in the U.S. and over 1 million worldwide, with about 90% of cases involving the lungs.

About Namilumab:
Namilumab is an anti-GM-CSF monoclonal antibody designed to be administered monthly via subcutaneous injection. GM-CSF is over-expressed in several inflammatory diseases, including sarcoidosis, and plays a key role in recruiting macrophages and monocytes to the lung, contributing to granuloma formation.