Kiniksa Starts Abiprubart Phase 2b Sjögren’s Trial Enrollment

Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA), a commercial-stage biopharmaceutical company specializing in immune-modulating treatments for cardiovascular and autoimmune diseases, has recently begun enrolling participants in a Phase 2b clinical trial for abiprubart, targeting Sjögren’s Disease. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody aimed at inhibiting the interaction between CD40 and CD154.

Sjögren’s Disease is a chronic autoimmune disorder with no FDA-approved treatments, making this trial a significant step forward for affected patients. Sanj K. Patel, Chairman and CEO of Kiniksa, emphasized the importance of this development, noting that it builds on both external mechanistic proof-of-concept and prior clinical data from Kiniksa. Patel highlighted abiprubart's potential to address unmet medical needs through its convenient subcutaneous administration. Kiniksa aims to remain cash flow positive while funding the clinical development of abiprubart in Sjögren’s Disease.

The Phase 2b trial is a randomized, double-blind, placebo-controlled study assessing the efficacy of chronic subcutaneous administration of abiprubart in Sjögren’s Disease patients. Approximately 201 patients will be randomly assigned in a 1:1:1 ratio to receive either 400 mg of abiprubart biweekly, 400 mg monthly, or a placebo for 24 weeks. The primary endpoint is the change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) compared to the placebo at Week 24. Following this period, all patients will enter a long-term extension phase where they will receive active treatment for an additional 24 weeks.

Kiniksa is dedicated to discovering, acquiring, and developing therapeutic medicines for patients with significant unmet medical needs. The company's immune-modulating assets, including ARCALYST®, abiprubart, and mavrilimumab, are designed based on strong biological rationale or validated mechanisms. These assets target a range of underserved cardiovascular and autoimmune conditions and offer potential for differentiation in the market.

Abiprubart is a humanized monoclonal antibody that targets CD40 and inhibits the CD40-CD154 interaction, a vital T-cell co-stimulatory signal necessary for B-cell maturation, immunoglobulin class switching, and Type 1 immune responses. Kiniksa believes that disrupting this co-stimulatory interaction is a promising approach to treating multiple autoimmune diseases.