- The 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.
- Study 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.
- COYA 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.
- Over 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.
- COYA 302 appeared to be well tolerated in all study patients.
Coya 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 announced it will host a conference call to present positive clinical data announced earlier today, of Coya’s proprietary investigational biologic combination, COYA 302, in patients with Amyotrophic Lateral Sclerosis (ALS), today at 8:00am ET.
During the call, Dr. Stanley Appel, the chair of Coya’s Scientific Advisory Board, will provide commentary on the data summarizing work conducted at his lab at Houston Methodist Hospital. Following Dr. Appel's comment's, Dr. Howard Berman, Coya's CEO, and Dr. Adrian Hepner, Coya's CMO, will provide additional comments on the impact of this data on Coya's clinical pipeline and upcoming clinical and regulatory milestones.
Conference Call Information
Date: Tuesday, March 21, 2023
Time: 8:00 AM Eastern Time
Toll Free: 888-506-0062
Participant Access Code: 666962
Live Webcast link: https://www.webcaster4.com/Webcast/Page/2956/47797
Toll Free: 877-481-4010
Replay Passcode: 47797
Webcast replay link: https://www.webcaster4.com/Webcast/Page/2956/47797
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to a sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Coya’s 300 Series product candidates, COYA 301 and COYA 302, are biologic therapies intended to enhance Treg function and expand Treg numbers. COYA 301 is a cytokine biologic for subcutaneous administration intended to enhance Treg function and expand Treg numbers in vivo, and COYA 302 is a biologic combination for subcutaneous and/or intravenous administration intended to enhance Treg function while depleting T effector function and activated macrophages. These two mechanisms may be additive or synergistic in suppressing inflammation. For more information about Coya, please visit www.coyatherapeutics.com.
About Muscle Dystrophy Association
Muscular Dystrophy Association (MDA) is the #1 voluntary health organization in the United States for people living with muscular dystrophy, ALS, and related neuromuscular diseases. For over 70 years, MDA has led the way in accelerating research, advancing care, and advocating for the support of our families. MDA's mission is to empower the people we serve to live longer, more independent lives. To learn more visit mda.org and follow MDA on Instagram, Facebook, Twitter, TikTok, LinkedIn, and YouTube.
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