Kiniksa Announces Rilonacept Interim Phase 2 Clinical Data and Initiates Pivotal Phase 3 Clinical Trial

Kiniksa Pharmaceuticals (Nasdaq: KNSA) a biopharmaceutical company with a pipeline of five product candidates across various stages of development, today announced interim data from an open-label Phase 2 clinical trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein that blocks IL-1α and IL-1β signaling, in subjects with symptomatic recurrent pericarditis. The data show reductions in both inflammation and reported pain after the first dose which persisted throughout the treatment period.

As quoted in the press release:

“We are focused on rapidly developing rilonacept in recurrent pericarditis as a potential treatment for this unmet medical need,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “Pericarditis is a debilitating disease where recurrence leads to higher risk of relapse and impacts quality of life. Rilonacept has the potential to be the first approved therapy for patients suffering from recurrent pericarditis.”

Kiniksa recently completed enrollment in an open-label Phase 2 pilot study, which is evaluating the treatment response to rilonacept in subjects with both symptomatic recurrent pericarditis as well as other patient subsets within pericarditis, including asymptomatic steroid-dependent subjects with recurrent pericarditis and subjects with post-pericardiotomy syndrome. In this study, all subjects receive a loading dose of rilonacept 320 mg subcutaneously (SC) followed by 160 mg SC weekly maintenance on top of any combination of co-administered nonsteroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids during a 6-week base treatment period. An optional 18-week extension period follows during which weaning off of concomitant NSAIDs, colchicine and corticosteroids is allowed.

Click here to read the full press release.