Development to stop on namilumab as pulmonary sarcoidosis treatment
Kinevant therapy failed to show benefit in patients in Phase 2 trial
Kinevant Sciences’ experimental therapy namilumab failed to show a benefit for people with chronic, active pulmonary sarcoidosis in a Phase 2 clinical trial involving more than 100 patients.
Based on the negative results of the RESOLVE-Lung study (NCT05314517), the company announced it will be discontinuing further development of namilumab as a potential pulmonary sarcoidosis treatment.
“I would like to thank all the patients who courageously volunteered to participate in the study, as well as the Kinevant team, industry partners, principal investigators, site staff, and patient advocacy groups who all worked together to successfully conduct this important study for sarcoidosis,” Bill Gerhart, CEO of Kinevant, said in a company press release.
The company plans to publish detailed results from the study in hopes of helping future efforts to develop new treatments for sarcoidosis, according to the release.
“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 patients,” Gerhart said.
Namilumab fails to meet primary, secondary goals in trial
Pulmonary sarcoidosis is an inflammatory disease marked by abnormal clumps of immune cells, called granulomas, that form in the lungs. These granulomas cause damage that leads to symptoms such as coughing and difficulty breathing among patients.
An antibody-based therapy, namilumab was designed to block the activity of an inflammatory signaling molecule, called granulocyte-macrophage colony-stimulating factor or GM-CSF, that’s thought to play a role in the formation of granulomas.
Kinevant launched the Phase 2 RESOLVE-Lung trial to assess the safety and efficacy of namilumab in adults with chronic pulmonary sarcoidosis that wasn’t effectively managed with available therapies.
The study began dosing patients in late 2022, and a total of 107 participants were randomly assigned to receive either namilumab or a placebo, given by subcutaneous, or under-the-skin, injection once monthly for about six months.
The trial’s main goal was to assess whether or not namilumab was superior to the placebo in helping patients avoid the need for rescue treatment for worsening sarcoidosis. The results, however, showed no significant group differences in the proportion of patients needing rescue treatment.
It’s evident from our data that the RESOLVE-Lung study was thoughtfully designed and gave us a clear read on the potential benefits of namilumab in this patient population. … Unfortunately science is sometimes humbling. … We are proud to have made the attempt.
Secondary efficacy goals, including changes in measures of lung function, quality of life, and the proportion of patients achieving oral corticosteroid tapering without the need for rescue treatment, also showed no significant differences between the namilumab and placebo groups.
The therapy’s safety profile was consistent with that reported in previous studies, according to Kinevant.
Matt Gline, CEO of Kinevant’s parent company Roivant Sciences, noted the negative results were disappointing, but added that, from a research perspective, it nonetheless proved useful to have clear-cut, unambiguous results.
“It’s evident from our data that the RESOLVE-Lung study was thoughtfully designed and gave us a clear read on the potential benefits of namilumab in this patient population,” Gline said. “Unfortunately science is sometimes humbling. … We are proud to have made the attempt.”
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