Kiniksa Pharmaceuticals Announces Trial Design of Planned Phase 2/3 Clinical Trial of KPL-387 in Recurrent Pericarditis

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[{"type":"text","content":"– KPL-387 Phase 2/3 trial on track to initiate in mid-2025; Phase 2 data expected in 2H 2026 –– KPL-387 Phase 1 single ascending dose data support profile for monthly dosing –– Presentation and webcast at Jefferies 2025 Global Healthcare Conference scheduled for 12:50 pm ET today– LONDON, June 05, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today announced details for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, expected to initiate in the middle of 2025. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β). “We leveraged our expertise in this indication and experience with the RHAPSODY study design to plan this pivotal phase 2/3 study. We believe KPL-387 could provide a meaningful addition to the therapeutic options available to patients,” said John F. Paolini, M.D., Ph.D., FACC, Chief Medical Officer of Kiniksa. “We are eager to advance KPL-387, with its target profile of monthly dosing in a single subcutaneous injection in a liquid formulation, through this pivotal Phase 2/3 clinical trial and to patients in need. We expect to initiate the study in the middle of this year, with data from the dose-focusing portion expected in the second half of 2026.” Phase 2/3 Clinical Trial of KPL-387 in Recurrent PericarditisKiniksa is on track to initiate a Phase 2/3 clinical trial designed to evaluate the efficacy and safety of KPL-387 administered subcutaneously (SC) in patients with recurrent pericarditis. The trial will consist of three overlapping parts combined into a single protocol: a dose-focusing portion (Phase 2), a pivotal portion (Phase 3), and long-term extensions (LTE). The dose-focusing portion of the trial will enroll up to approximately 80 participants with recurrent pericarditis randomized in a 1:1:1:1 ratio to receive KPL-387 300 mg SC biweekly, 300 mg SC monthly, 100 mg SC biweekly, and 100 mg SC monthly. The primary efficacy endpoint is time to treatment response at Week 24. Subsequently, active, enrolled participants may be eligible to e...

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