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Kiniksa Reports Second Quarter 2020 Financial Results and Highlights Recent Pipeline and Corporate Activity

Published: 2020-07-30 11:30:00 ET
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– Rilonacept pivotal Phase 3 trial in recurrent pericarditis met statistical significance for primary and all major secondary efficacy endpoints; sBLA submission expected this year –

– Mavrilimumab global Phase 2/3 adaptive design trial in severe COVID-19 pneumonia and hyperinflammation enrolling and dosing patients –

– Data from mavrilimumab global Phase 2 trial in GCA and KPL-404 Phase 1 trial expected in Q4 2020 –

– Initiation of dose-ranging Phase 2b trial of vixarelimab in prurigo nodularis expected in Q4 2020 –

– Recent public offerings and concurrent private placements raised a total of ~$220 million in net proceeds; cash reserves expected to fund current operating plan into 2023 –       

HAMILTON, Bermuda, July 30, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today reported second quarter 2020 financial results and highlighted recent pipeline and corporate activity.

“Kiniksa had a brilliant first half of 2020, marked by statistically significant results from the pivotal Phase 3 study of rilonacept in recurrent pericarditis and the Phase 2a study of vixarelimab in prurigo nodularis as well as the COVID-19 mavrilimumab data published in The Lancet Rheumatology,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “The second half of the year is also expected to be catalyst-filled. We are committed to submitting an sBLA to the FDA for rilonacept in recurrent pericarditis this year and look forward to bringing this potential treatment to patients as soon as possible. Our evaluations of mavrilimumab in severe COVID-19 pneumonia and vixarelimab in prurigo nodularis are also progressing, and we continue to expect data in the fourth quarter from the mavrilimumab GCA trial and from our anti-CD40 program, KPL-404. We expect the recent capital raises and continued financial discipline to extend our cash runway into 2023.”

Pipeline ActivityRilonacept (IL-1α and IL-1β cytokine trap)

  • Kiniksa announced data from RHAPSODY, a global, randomized withdrawal design, pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis, a painful autoinflammatory cardiovascular disease. The primary efficacy endpoint of time-to-first adjudicated pericarditis recurrence in the randomized withdrawal period was highly statistically significant: rilonacept treatment resulted in a 96% reduction in risk of recurrent pericarditis events (Hazard Ratio = 0.04, p