Kiniksa Announces American College of Rheumatology Convergence 2020 Late-Breaking Abstracts Presentation of Mavrilimumab Phase 2 Giant Cell Arteritis Data

Primary and secondary efficacy endpoints achieved statistical significance; mavrilimumab reduced risk of flare and increased sustained remission

HAMILTON, Bermuda, Nov. 09, 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 that data from the global Phase 2 clinical trial of mavrilimumab in giant cell arteritis (GCA) were presented at the late-breaking abstracts session during the American College of Rheumatology (ACR) Convergence 2020. Mavrilimumab is an investigational fully-human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα). Both the primary and secondary efficacy endpoints achieved statistical significance, and there was a consistent trend of efficacy across the new onset and relapsing/refractory cohorts.

“There is a real need for novel therapies for patients with giant cell arteritis,” said Dr. Maria Cid, Hospital Clínic, University of Barcelona, IDIBAPS. “My fellow co-principal investigator, Dr. Sebastian Unizony, and I presented data which show that mavrilimumab significantly reduced risk of flare and increased sustained remission compared to placebo. This is an encouraging potential therapeutic advancement for these patients, particularly for those with relapsed/refractory disease, as many are not able to achieve sustained remission on current standard of care. I look forward to further investigation of mavrilimumab in subsequent clinical trials.”

Dr. Maria Cid¹, a co-principal investigator for the global Phase 2 trial, delivered a virtual presentation entitled Mavrilimumab (Anti GM-CSF Receptor α Monoclonal Antibody) Reduces Risk of Flare and Increases Sustained Remission in a Phase 2 Trial of Patients with Giant Cell Arteritis at the late-breaking abstracts session (L06 - L11) on Monday, November 9, 2020 at 11:30 a.m. Eastern Time. Dr. Sebastian Unizony² is a co-principal investigator.

The Phase 2 trial randomized 70 patients 3:2 to mavrilimumab 150 mg (n=42) or placebo (n=28) biweekly injected subcutaneously, co-administered with a protocol-defined 26-week oral corticosteroid taper. Patients were stratified by new onset (n=35) or relapsing/refractory (n=35) disease.

Both the primary efficacy endpoint of time-to-first adjudicated GCA flare by Week 26 in all treated patients (Hazard Ratio = 0.38, p=0.0263) and the secondary efficacy endpoint of sustained remission at Week 26 in all treated patients (33.3 percentage point increase; p=0.0038) were statistically significant. Additionally, while the trial was not powered for individual disease cohorts, there was a consistent trend of efficacy across the new onset and relapsing/refractory cohorts.