– Abiprubart Phase 2b trial in Sjogren’s Disease planned to initiate in 2H 2024 –– Abiprubart Phase 2 Cohort 4 rheumatoid arthritis data further validate biological activity –– Abiprubart development in Sjogren’s Disease fully funded through Phase 3 –– Company expects to remain cash flow positive on an annual basis within current operating plan –

HAMILTON, Bermuda, April 02, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (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 plans to initiate a Phase 2b trial with abiprubart in Sjogren’s Disease. Additionally, the company announced data from Cohort 4 of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis. Abiprubart is an investigational humanized anti-CD40 monoclonal antibody designed to inhibit CD40-CD154 (CD40 ligand) interaction.

“We believe abiprubart has the potential to provide meaningful benefit to patients suffering from Sjogren’s Disease, a debilitating disorder with no current FDA-approved therapies. Based on the clear biological activity demonstrated by abiprubart, potential for convenient subcutaneous administration, and external proof-of-concept of inhibition of the CD40-CD154 interaction, we plan to initiate a Phase 2b trial of abiprubart in Sjogren’s Disease in the second half of 2024,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “Supported by our robust ARCALYST revenue growth and current cash position, we continue to execute a strategic and disciplined capital allocation approach in areas we believe provide the best opportunity to drive long-term value. Based on our current operating plan, which includes advancement of abiprubart through Phase 3 development in Sjogren’s Disease, we expect to remain cash flow positive on an annual basis.”

Phase 2b Clinical Trial of Abiprubart in Sjogren’s DiseaseKiniksa is planning to initiate a randomized, double-blind, placebo-controlled Phase 2b trial designed to evaluate the treatment response of chronic subcutaneous (SC) administration of abiprubart in patients with Sjogren’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 will be change from baseline in EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) versus placebo at Week 24. Subsequently, patients will enter a long-term extension in which all patients will receive active treatment for an additional 24 weeks. The trial is expected to initiate in the second half of 2024.

Abiprubart Phase 2 Rheumatoid Arthritis DataThe Phase 2 rheumatoid arthritis trial uses a randomized, double-blind, placebo-controlled design to evaluate pharmacokinetics (PK), safety, and efficacy of chronic SC administration of abiprubart and to provide optionality to evaluate abiprubart across a range of autoimmune diseases. The trial enrolled patients with active rheumatoid arthritis who had an inadequate response or were intolerant to a Janus kinase inhibitor (JAKi) or at least one biologic disease-modifying anti-rheumatic drug (bDMARD).

Following previously reported topline data, Kiniksa today announced final data from the first three cohorts of the clinical trial:

• In Cohorts 1 and 2, multiple doses of abiprubart were well-tolerated and enabled the proof-of-concept portion of the study.
• In the Cohort 3 abiprubart 5 mg/kg SC weekly dose group (n=27), the Least Squares (LS) mean change [95% confidence interval (CI)] from baseline in Disease Activity Score of 28 Joints Using C-reactive Protein (DAS28-CRP) at Week 12 was -2.17 [-2.60, -1.74] points, compared to -1.61 [-2.04, -1.17] points in placebo recipients (n=26), (LS Mean Difference = -0.57, p=0.0470).
• In the Cohort 3 abiprubart 5 mg/kg SC biweekly dose group (n=25), the LS mean change [95% CI] from baseline in DAS28-CRP at Week 12 was -1.96 [-2.40, -1.52] points, compared to -1.61 [-2.04, -1.17] points in placebo recipients (n=26), (LS Mean Difference = -0.36, p=0.2124).
• There was a statistically significant reduction of over 40% in Rheumatoid Factor, a clinical marker of disease activity and an autoantibody pharmacodynamic marker of CD40 target engagement, in both Cohort 3 abiprubart dose groups (p