The clinical stage biotech company focused on the therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation, Coya Therapeutics, Inc. (NASDAQ: COYA) has announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COYA 302, a proprietary biologic therapy designed to enhance regulatory Tregfunction in patients with amyotrophic lateral sclerosis (ALS).
The FDA’s acceptance paves the way for Coya to initiate a Phase 2 multicenter, double-blind, placebo-controlled clinical study to assess the efficacy and safety of COYA 302 in ALS patients. The trial represents a key milestone in the company’s strategy to bring forward novel immunomodulatory therapies for neurodegenerative disorders.
Arun Swaminathan, Chief Executive Officer, stated, “The FDA’s acceptance of this IND marks a pivotal moment in Coya’s journey. We are now preparing to initiate a well-powered, well-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS. We are grateful to the ALS community for their continued support of this important program.”
The progress was also highlighted by Coya’s strategic partner, Dr. Reddy’s Laboratories Ltd. (DRL). Milan Kalawadia, CEO of DRL North America, commented, “We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study. This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energized by the potential of moving a step closer to offering a treatment for patients living with ALS, also known as Lou Gehrig’s disease.”
As part of its agreement with DRL, FDA acceptance of the IND triggers a $4.2 million milestone payment to Coya, strengthening its financial resources as it prepares to launch the upcoming Phase 2 program.
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 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
This article contains sponsored content. Please see our disclaimer at: https://prismmarketview.com/disclaimer/
The post Coya Therapeutics Wins FDA Clearance to Advance ALS Therapy into Phase 2 Trial appeared first on PRISM MarketView.
