Namilumab Fails to Meet Primary Endpoint in Phase 2 RESOLVE-Lung Study for Pulmonary Sarcoidosis
核心洞察
Kinevant Sciences (搜索)' Phase 2 RESOLVE-Lung study of namilumab in chronic active pulmonary sarcoidosis (搜索) did not demonstrate a statistically significant treatment benefit.
The primary endpoint, proportion of subjects with a Rescue Event, was not met, and secondary endpoints showed no consistent treatment benefit.
Due to these results, Kinevant will discontinue further development of namilumab for the treatment of sarcoidosis (搜索).
Kinevant Sciences (搜索)' Phase 2 RESOLVE-Lung study evaluating namilumab for chronic active pulmonary sarcoidosis (搜索) has failed to meet its primary endpoint. The trial, which assessed the efficacy and safety of the investigational anti-GM-CSF monoclonal antibody, did not show a statistically significant treatment benefit in patients with this rare inflammatory lung disease.
The RESOLVE-Lung study (NCT05314517) was a randomized, double-blind, placebo-controlled trial conducted at sites in the U.S. and Europe. It enrolled 107 patients with pulmonary sarcoidosis (搜索) characterized as chronic, active disease that was not well-controlled by available therapies. Participants received a once-monthly subcutaneous injection of either namilumab or placebo for approximately six months.
The primary endpoint was the proportion of subjects experiencing a Rescue Event during the double-blind period, defined as clinically significant worsening of sarcoidosis (搜索) requiring treatment, failure to adhere to a protocol-defined oral corticosteroid (OCS) taper, or premature discontinuation from the study due to lack of benefit. Namilumab did not demonstrate a significant difference compared to placebo in this measure.
Secondary efficacy endpoints, including change in percent predicted forced vital capacity, corticosteroid tapering success, and change in the patient-reported King’s Sarcoidosis (搜索) Questionnaire, also failed to show a treatment benefit consistent with the primary endpoint. The safety profile of namilumab in the RESOLVE-Lung study was consistent with previous studies.
"Although RESOLVE-Lung failed to show a treatment benefit for namilumab, the significant amount of information produced by the study will be tremendously helpful to those in the field who are committed to improving the lives of sarcoidosis (搜索) patients," said Bill Gerhart, CEO of Kinevant.
With the trial's disappointing outcome, Kinevant has decided to discontinue further development of namilumab for the treatment of sarcoidosis (搜索). The company intends to publish the complete results of the RESOLVE-Lung study to inform future research efforts in the field.
Pulmonary sarcoidosis (搜索) is characterized by the formation of granulomas (clumps of immune cells) in the lungs, leading to breathlessness, fatigue, and pain. In the U.S., approximately 200,000 people are affected by sarcoidosis (搜索), with about 90% of cases involving the lung. Current treatments, such as oral steroids and immunosuppressants, are often limited by their effectiveness and potential side effects.
Namilumab is an anti-GM-CSF monoclonal antibody. Granulocyte macrophage colony stimulating factor (GM-CSF) is a pro-inflammatory cytokine over-expressed in several inflammatory diseases, including sarcoidosis (搜索). GM-CSF mediated pro-inflammatory signaling is thought to play a central role in recruitment of macrophages and monocytes to the lung and to trigger a granulomatous response, including the fusion of macrophages into multinucleated giant cells.