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Coya Therapeutics, Inc. Announces Positive Results from a Proof-of-Concept Academic Clinical Study for COYA 302 in Amyotrophic Lateral Sclerosis (ALS)
The proof-of-concept open-label study evaluated the safety and tolerability, function of regulatory T cells (Tregs), biomarkers, and preliminary efficacy (as
About this update from Coya Therapeutics, Inc.
[{"type":"text","content":"\n\nThe proof-of-concept open-label study evaluated the safety and tolerability, function of regulatory T cells (Tregs), biomarkers, and preliminary efficacy (as measured by the ALSFRS-R scale) of COYA 302 over 48 weeks and was conducted in four ALS patients at the Houston Methodist Hospital by Dr. Stanley Appel and Dr. Jason Thonhoff.\n\n\nStudy data showed no decline or minimal decline at 24 and 48 weeks, respectively, after initiation of treatment in a group of patients experiencing a mean decline of -1.1 points/month in their ALSFRS-R score prior to initiation of treatment with COYA 302. The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), indicating significant amelioration in the progression of the disease.\n\n\nCOYA 302 is an investigational combination biologic for subcutaneous administration, comprised of COYA 301 (low dose IL-2) and CTLA4-Ig fusion protein. COYA 302 has a dual mechanism of action and is intended to enhance Treg function in vivo, and downregulate the function of T effector cells, proinflammatory cells, and lipid peroxides.\n\n\nOver the course of treatment, COYA 302 significantly enhanced Treg suppressive function at 24 weeks and 48 weeks and lowered serum biomarkers of inflammation and oxidative stress.\n\n\nCOYA 302 appeared to be well tolerated in all study patients.\n\n\n HOUSTON--(BUSINESS WIRE)--\nCoya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic platforms intended to enhance Treg function, including biologics and cell therapies, today reported 48-week clinical data for its proof-of-concept open-label study in 4 ALS patients indicating that treatment with COYA 302 appeared to ameliorate disease progression.\n\nFour ALS patients with a mean decline of -1.1 points/month in the Revised ALS Functional Rating Scale (ALSFRS-R) score prior to study initiation, were treated for 48 consecutive weeks with COYA 302 and were evaluated for safety and tolerability, Treg suppressive function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale. Following the administration of COYA 302 for 48 weeks, patients were evaluated ove...