Kinevant Sciences, a Roivant spinout designed to test an investigational monoclonal antibody, has reported that the asset failed to help patients with an inflammatory lung disease in a midstage trial.
Given the results, Kinevant is terminating development of the candidate—dubbed namilumab—as a potential sarcoidosis treatment, according to a Dec. 3 company release.
The phase 2 study, called RESOLVE-Lung, enrolled 107 patients with chronic active pulmonary sarcoidosis, a disease that can cause breathlessness, fatigue and pain. If not treated effectively, the inflammation can lead to lung scarring, dysfunction and eventually failure. Current therapies include oral steroids, such as prednisone, which can lack efficacy or prompt serious side effects.
The double-blind trial assessed once-monthly injections of namilumab compared to placebo over six months, with a 28-week open-label extension treatment study offered to patients who completed the initial trial.
The primary endpoint of RESOLVE-Lung measured the proportion of subjects with a “rescue event,” meaning the significant worsening of sarcoidosis that required treatment, failing to follow the trial’s oral corticosteroid taper protocol for individuals taking steroids, or premature discontinuation from the study due to a lack of treatment benefit. The study didn’t hit the key measure, failing to show treatment benefit in patients, according to the release.
Secondary endpoints, such as the change in percent predicted forced vital capacity, corticosteroid tapering success and change in the patient-reported questionnaire, also failed to demonstrate benefit.
Kinevant will now end any further development of the anti-GM-CSF monoclonal antibody in sarcoidosis, with the full results of the study expected to be published later to inform future research efforts, according to the company.
“Risk-taking in clinical development is at the heart of our industry, and core to Roivant’s mission of developing new medicines for patients in need. 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,” Roivant CEO Matt Gline said in a Dec. 3 release. “Unfortunately, science is sometimes humbling, and we are proud to have made the attempt, as well as of our successes in other programs this year. We look forward to taking calculated risks on similar programs in the future.”
Namilumab, designed to treat inflammatory and autoimmune diseases, has known many homes.
Takeda previously licensed the candidate to Izana Bioscience for a severe form of arthritis. In 2020, Roivant quietly bought Izana, bringing the asset into the Roivant fold. Eventually, a phase 2 study of namilumab in axial spondyloarthritis read out, revealing no efficacy benefit, according to results published in the Lancet in July.
As for Kinevant, one of the many “vants” that Roivant has created to advance specific medicines, the future remains unclear. Namilumab is Kinevant’s sole pipeline candidate, with the sarcoidosis trial the only study listed on the company’s site.
Roivant, known for taking high-risk drugs that have previously failed, tested out namilumab even after Takeda dropped a program assessing the candidate in rheumatoid arthritis.
Earlier this year, another one of Roivant’s ventures, dubbed Hemavant, shuttered after discontinuing development of its only asset after a midstage trial in myelodysplastic syndromes (MDS) failed to meet Roivant’s “bar for progressing,” CEO Gline said at the time. Roivant still saw promise in the candidate, even after Eisai evaluated that candidate in MDS and other blood cancers and saw no complete or partial responses in the first 84 participants.
Hemavant’s team was mainly staffed by Roivant personnel who were expected to be redeployed, a Roivant spokesperson had told Fierce Biotech.