World News: 12:30 GMT Wednesday 12th June 2019. [Kiniksa Pharmaceuticals, Ltd. via Globe Newswire via SPi World News]
HAMILTON, Bermuda, June 12, 2019 (GLOBE NEWSWIRE) -- (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, today announced that it presented preclinical data on the granulocyte macrophage colony stimulating factor (GM-CSF) signaling pathways in temporal arteries of patients with giant cell arteritis (GCA) at the European League Against Rheumatism’s (EULAR) European Congress of Rheumatology in Madrid, Spain.
“The preclinical data presented at EULAR underscore the mechanistic rationale of targeting GM-CSFRα in patients with GCA,” said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. “GM-CSF, GM-CSFRα, and their associated signaling molecules were shown to be significantly upregulated in temporal arteries of GCA patients. Furthermore, mavrilimumab was shown to suppress the increased expression of genes associated with this inflammatory pathway. We are continuing to advance our global Phase 2 clinical trial of mavrilimumab in GCA and look forward to presenting top-line data in the second half of 2020.”
Dr. Maria C. Cidis a lead author of the poster presentation entitled .
The materials are available through the Investors and Media section of Kiniksa’s website ().
Kiniksa is developing mavrilimumab, an investigational fully-human monoclonal antibody that is designed to antagonize GM-CSF signaling by binding to the alpha subunit of the GM-CSF receptor, for the potential treatment of GCA.
GCA is a chronic inflammatory disease of medium-large blood vessels that causes headaches, jaw and other muscle claudication as well as ischemic visual loss. Kiniksa estimates U.S. prevalence of approximately 75,000 to 150,000 patients with similar prevalence rates for other major markets.
Kiniksa is enrolling a randomized, double-blind, placebo-controlled, global Phase 2 proof-of-concept clinical trial of mavrilimumab in subjects with GCA. The trial is expected to enroll approximately 60 subjects with new-onset and refractory disease. Subjects will be randomized 3:2 to mavrilimumab 150 mg or placebo injected subcutaneously once every 2 weeks co-administered with a corticosteroid taper. The primary efficacy endpoint involves measuring GCA flares during the 26-week treatment period. Top-line data are expected in the second half of 2020.
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2019, filed with the Securities and Exchange Commission (“SEC”) on May 7, 2019, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Globe Newswire: 12:30 GMT Wednesday 12th June 2019
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