Kiniksa Announces Preliminary Data from Phase 1 Trial of KPL-404

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[{"type":"text","content":"- Receptor occupancy and TDAR suppression shown through Day 29 at 3 mg/kg intravenous –\n - Data to-date support subsequent study in patients, including potential intravenous or subcutaneous monthly administration - - Final data and safety follow-up from all cohorts expected in 1H 2021 - HAMILTON, Bermuda, Nov. 30, 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 preliminary data from the Phase 1 clinical trial of KPL-404 in healthy volunteers. KPL-404 is a monoclonal antibody inhibitor of the CD40-CD40 ligand (CD40L) interaction, a central control node of T-cell dependent, B-cell mediated humoral adaptive immunity. “The preliminary data from the single-ascending-dose Phase 1 study of KPL-404 are encouraging,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “We believe the data generated to-date suggest that KPL-404 has the potential to address a broad range of autoimmune diseases. We expect final data and safety follow-up from all cohorts of the Phase 1 study in the first half of 2021.” The Phase 1 trial of KPL-404 is a randomized, double-blind, placebo-controlled, single-ascending-dose, first-in-human study that is divided into two parts: a single dose of KPL-404 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg intravenously (IV) and a single dose of KPL-404 1 mg/kg or 5 mg/kg subcutaneously (SC). The primary objective is to assess the safety and tolerability of KPL-404. Secondary endpoints include pharmacokinetics, CD40 receptor occupancy (RO), the immune response to the novel test antigen keyhole limpet hemocyanin (KLH) in clinically relevant dose cohorts, and the anti-drug antibody response. All dose escalations occurred as per protocol with no dose limiting safety findings. All 6 subjects dosed with KPL-404 3 mg/kg IV showed full receptor occupancy through Day 29, which corresponded with complete suppression of the T-cell Dependent Antibody Response (TDAR) to KLH through Day 29. Consistent dose relatedness was shown in the lower dose level cohorts, including 0.03 mg/kg, 0.3 mg/kg, 1 mg/kg IV and 1 mg/kg SC. Data collection for the higher dose level cohorts, 10 mg/kg IV and 5 mg/kg SC, is ongoing. The data to-da...

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