Coya Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for COYA 302 for the Treatment of Frontotemporal Dementia (FTD)
Coya Therapeutics, Inc. (NASDAQ:COYA) ("Coya" or the "Company"), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, announces that the U.S. Food and Drug Administration (FDA) has accepted the Company's IND for COYA 302 for the treatment of frontotemporal dementia (FTD).
FTD is the most common form of dementia in people under the age of 65, affecting about 60,000 Americans. The average age of onset is 58, with an average survival time of 7.5 years. FTD is characterized by loss of intellectual functions, such as memory problems, impaired abstract thinking, reasoning, and executive function, that are severe enough to hamper activities of daily living. The clinical manifestations include behavior changes, dietary changes, loss of empathy, apathy, and executive function. FTD constitutes a high unmet medical need, as there is no treatment to stop or ameliorate the progression of the disease.
Dr. Adam Boxer, Professor of Neurology at UCSF and a noted FTD clinical trials expert, said, "There is a great need to develop disease modifying treatments for patients with FTD since none exist today. I am pleased to see this new treatment approach with a strong scientific rationale being moved forward toward a clinical trial for sporadic FTD. I commend Coya for advancing COYA 302 into well-controlled clinical trials for these patients."
Dr. Fred Grossman, Chief Medical Officer at Coya said, "There is growing evidence for the relationship between neuroinflammation and progression of FTD. We believe the dual mechanism of COYA 302, which is designed to enhance the anti-inflammatory function of Tregs, provides a strong scientific rationale for evaluating this therapy in patients with FTD."
Coya expects to announce topline results from the previously announced investigator-initiated open-label study evaluating low-dose IL-2 and CTLA4-Ig in patients with mild-to-moderate FTD in the coming weeks.
About COYA 302
COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS, and other neurodegenerative diseases. These mechanisms may have additive or synergistic effects.
Coya is currently conducting the ALSTARS Trial, a Phase 2, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of COYA 302 for the treatment of ALS (ClinicalTrials.gov Identifier: NCT 07161999).
COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.
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. This cellular dysfunction may lead to 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.
For more information about Coya, please visit www.coyatherapeutics.com
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