Kiniksa Pharmaceuticals Commences Enrollment in Abiprubart Phase 2b Clinical Trial in Sjögren’s Disease

2024-07-11

– Abiprubart Phase 2b clinical trial in Sjögren’s Disease to evaluate treatment response across biweekly and monthly subcutaneous administrations –

– Abiprubart clinical development in Sjögren’s Disease fully funded; company expects to remain cash flow positive on an annual basis –

July 09, 2024 -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced that it has commenced enrollment of the Phase 2b clinical trial of abiprubart in Sjögren’s Disease. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.

“Sjögren’s Disease is a debilitating, chronic autoimmune disorder currently with no FDA-approved therapies. Commencing the next phase of development of abiprubart in Sjögren’s Disease is an important step forward for patients,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “This Phase 2b clinical trial builds on external mechanistic proof-of-concept as well as learnings from our own prior clinical data. Additionally, we believe abiprubart has the potential for differentiation in addressing unmet need through convenient subcutaneous administration. Importantly, our current operating plan includes clinical development of abiprubart in Sjögren’s Disease, and the company expects to remain cash flow positive on an annual basis.”

Phase 2b Clinical Trial of Abiprubart in Sjögren’s Disease

The randomized, double-blind, placebo-controlled Phase 2b clinical trial is designed to evaluate the treatment response of chronic subcutaneous (SC) administration of abiprubart in patients with Sjögren’s Disease.

The placebo-controlled portion of the trial will randomize approximately 201 patients in a 1:1:1 ratio to receive abiprubart 400 mg SC biweekly, 400 mg SC monthly, or placebo over a period of 24 weeks. The primary endpoint is change from baseline in EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) versus placebo at Week 24. Subsequently, patients will enter a long-term extension in which active treatment will be given in all study arms for an additional 24 weeks.

About Kiniksa

Kiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST®, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more information, please visit www.kiniksa.com.

About Abiprubart

Abiprubart is an investigational humanized monoclonal antibody that binds to CD40 and is designed to inhibit the CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD154 co-stimulatory interaction is an attractive approach to addressing multiple autoimmune disease pathologies.

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