Kiniksa Provides Timing of Second Half 2020 Clinical Data Readouts

- Rilonacept pivotal Phase 3 data in recurrent pericarditis expected in Q3 2020 -

- Mavrilimumab Phase 2 data in GCA and KPL-404 Phase 1 data expected in Q4 2020 -

- Management to provide a corporate update at the 41^st Annual Goldman Sachs Global Healthcare Conference on Thursday, June 11^th at 3pm EDT -

HAMILTON, Bermuda, June 10, 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 announced that data from RHAPSODY, the pivotal Phase 3 trial of rilonacept (IL-1α and IL-1β trap) in recurrent pericarditis, are expected in the third quarter of 2020. Additionally, the company expects mavrilimumab (anti-GM-CSFRα) Phase 2 data in giant cell arteritis (GCA) and KPL-404 (anti-CD40) single-ascending-dose Phase 1 data in the fourth quarter of 2020.  

“Focused corporate and clinical execution year-to-date has led to significant advancements across our pipeline,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “We plan to build upon this progress throughout the second half of the year. Following the receipt of Breakthrough Therapy designation and a Type B meeting with the U.S. FDA, we were able to pull forward the timeline for pivotal Phase 3 rilonacept data into the third quarter. We also anticipate Phase 2 data for mavrilimumab and Phase 1 data for KPL-404 in the fourth quarter. Additionally, we plan to initiate a Phase 2/3 clinical trial for mavrilimumab in severe COVID-19 pneumonia and hyperinflammation and a Phase 2b dose-ranging trial for vixarelimab in prurigo nodularis.”

“We believe there is urgent need to bring an approved therapy to patients suffering from recurrent pericarditis,” said Qasim Rizvi, Chief Commercial Officer and SVP of Operations at Kiniksa. “We are focused on the key clinical outcomes measures in recurrent pericarditis that matter the most to patients and physicians: resolution of acute episodes, prevention of future recurrences while on treatment, tapering and discontinuation of corticosteroids, and improvement in quality of life. RHAPSODY is a pivotal Phase 3 clinical trial that has the potential to generate meaningful data to address these unmet clinical needs.”