Coya Therapeutics, Inc. (NASDAQ: COYA), a clinical-stage biotech developing therapies that enhance regulatory T cell (Treg) function in neurodegenerative disorders, has initiated the ALSTARS Trial, a Phase 2 clinical study evaluating the efficacy and safety of its investigational candidate COYA 302 in amyotrophic lateral sclerosis (ALS).

Trial Design and Scope

The ALSTARS Trial is designed as a randomized, multi-center, double-blind, placebo-controlled study that will enroll approximately 120 ALS patients across 25 sites in the United States and Canada. Participants will be randomized to receive one of two different doses of COYA 302 or placebo during a 24-week treatment period.

Following completion of the initial phase, patients will be invited to join a 24-week blinded extension. During this stage, all participants will receive COYA 302 at one of the prespecified doses, enabling researchers to evaluate longer-term safety and efficacy outcomes. The trial is registered under ClinicalTrials.gov identifier NCT07161999.

Presentation and Patient Access

Details on study eligibility and site enrollment are available through ClinicalTrials.gov, with additional locations expected to be added as the trial progresses. The study will also be highlighted during the NEALS Educational Webinar on September 29, 2025, presented by Dr. James Berry, MD, MPH.

Management Commentary

"The launch of the ALSTARS Trial represents a significant milestone in our mission to develop innovative therapies for patients with ALS," said Fred Grossman, Chief Medical Officer of Coya Therapeutics. "We believe COYA 302's unique mechanism of enhancing regulatory T cell number and function offers a promising new approach for this devastating disease with high unmet medical need. We look forward to evaluating its potential to meaningfully impact the lives of ALS patients and their families."

Broader Context

ALS remains a severe neurodegenerative condition with limited therapeutic options and a life expectancy of three to five years post-diagnosis. By targeting Treg function, Coya aims to address immune dysregulation thought to play a role in ALS progression. The company positions COYA 302 as part of its broader pipeline strategy to bring forward Treg-modulating biologics across neurodegeneration.

The initiation of ALSTARS marks Coya's most advanced step yet in validating COYA 302 as a potential treatment for ALS, with trial outcomes expected to provide pivotal insights into the therapy's clinical profile.

 

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

This article contains sponsored content. Please see our disclaimer at: https://prismmarketview.com/disclaimer/

The post Coya Therapeutics Launches Phase 2 ALSTARS Trial for ALS Candidate COYA 302 appeared first on PRISM MarketView.

COMTEX_468968397/2927/2025-09-22T12:30:22