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Coya Therapeutics' COYA 302 Trial: A Step Forward in ALS Research

Coya Therapeutics, Inc., a clinical-stage biotechnology company based in Houston, Texas, has made a remarkable stride in the fight against Amyotrophic Lateral Sclerosis (ALS) by having its COYA 302 Phase 2 clinical trial accepted by the Northeast ALS (NEALS) Consortium. This affiliation with NEALS, the world’s largest ALS research network, represents a significant milestone for Coya in its quest to bring innovative therapies to those impacted by this debilitating neurodegenerative disease.

The NEALS Consortium, established in 1995, comprises over 150 research centers across North America and is known for its collaborative efforts in advancing ALS research. This recognition not only underscores the potential significance of Coya’s therapeutic approach but also highlights the study's alignment with NEALS’ mission to accelerate the development of effective new treatments for ALS patients.

With more than 20,000 individuals living with ALS in the United States, the need for effective therapies has never been greater. Currently approved treatments offer limited benefits, leaving many patients and families searching for hope. The COYA 302 trial aims to evaluate the efficacy and safety of its investigational biologic therapy, which focuses on enhancing regulatory T cell (Treg) function to combat inflammation associated with ALS.

Coya's COYA 302 is a proprietary combination therapy designed to enhance the anti-inflammatory function of regulatory T cells (Tregs) while simultaneously suppressing the inflammatory responses produced by activated immune cells. This innovative mechanism of action, deploying low-dose interleukin-2 (LD IL-2) combined with CTLA-4 Ig, is intended for subcutaneous administration. The company believes that this dual approach may yield synergistic benefits in treating the underlying causes of ALS.

According to Dr. Fred Grossman, President and Chief Medical Officer of Coya, the recent affiliation with NEALS better positions the COYA 302 trial. He expressed gratitude for the recognition and excitement for the opportunity to collaborate with leading ALS researchers and clinical centers associated with NEALS.

The study is expected to commence in the fourth quarter of 2025, following the FDA's acceptance of the Investigational New Drug (IND) application for COYA 302. In anticipation of the trial, the study will be showcased during the NEALS Educational Webinar scheduled for September 29, 2025, led by Dr. James Berry from Mass General Hospital, a renowned expert in ALS research.

Dr. Berry noted that the unique approach of the COYA 302 trial could represent a new frontier in ALS treatment strategies. By enhancing Treg function, Coya’s therapy has the potential to address some of the critical inflammatory processes that underlie the progression of ALS, which currently lacks a cure.

Amyotrophic Lateral Sclerosis, also known as Lou Gehrig's disease, significantly affects motor neurons, leading to muscle degeneration and loss of voluntary control. Patients typically face a dire prognosis, with most succumbing to respiratory failure within three to five years following the onset of symptoms. This grave reality underscores the urgency of developing effective treatments.

Coya’s commitment extends beyond just COYA 302, as the company is driven by a vision to leverage Treg biology to target systemic inflammation across various neurological and autoimmune disorders. Their pipeline includes multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of regulatory T cells. This comprehensive strategy reflects Coya's understanding of the complexities of immune system dysregulation in neurodegenerative diseases.

In summary, Coya Therapeutics stands at the forefront of innovation with its COYA 302 trial, now recognized as a NEALS-affiliated study. This collaboration not only enhances the trial's credibility but also holds promise for many individuals battling ALS. As Coya moves forward with enthusiasm, the ALS community remains hopeful for advancements that could reshape the therapeutic landscape for this challenging condition. The upcoming Phase 2 study could bring a significant leap toward finding effective treatments that improve the quality of life for ALS patients and their families.