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Kiniksa Announces New England Journal of Medicine Publication of Rilonacept Phase 3 Data in Recurrent Pericarditis and Late-Breaking Science Presentation at American Heart Association Scientific Sessions 2020

Published: 2020-11-17 13:00:00 ET

HAMILTON, Bermuda, Nov. 17, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today announced that data from RHAPSODY, the pivotal Phase 3 trial of rilonacept in recurrent pericarditis, were published in The New England Journal of Medicine. Additionally, the RHAPSODY data were presented at the late-breaking science session during the American Heart Association (AHA) Scientific Sessions 2020. Kiniksa previously reported positive top-line RHAPSODY results in June 2020. Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.

The manuscript entitled Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis, is available on The New England Journal of Medicine website with open access for seven days.

The AHA presentation entitled RHAPSODY: Rilonacept an IL-1α and IL-1β Trap Resolves Pericarditis Episodes and Reduces Risk of Recurrence in a Phase 3 Trial of Patients with Recurrent Pericarditis was presented virtually by Allan Klein, MD, of Cleveland Clinic, co-principal investigator of the study and compensated member of a 2019 Kiniksa scientific advisory committee. Massimo Imazio, MD, of the University of Torino, Italy, is co-principal investigator.

“Recurrent pericarditis is a debilitating autoinflammatory disease with a clear unmet need,” said Dr. Klein. “Data were reported which showed that patients treated with rilonacept experienced a 96% reduction in risk of recurrent pericarditis events. Furthermore, in acutely symptomatic patients who were failing standard management, rilonacept treatment in the study provided rapid and sustained reductions in pain and C-reactive protein as soon as after the first dose. These data suggest that targeted immunomodulation with rilonacept may signal a paradigm shift in the management of patients with recurrent pericarditis.”

In RHAPSODY, the primary efficacy endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period was highly statistically significant (Hazard Ratio = 0.04, p

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