#United States #Houston #Coya Therapeutics #COYA 302 #ALSTARS Trial

Coya Therapeutics Launches the ALSTARS Trial

Coya Therapeutics, Inc., a biotechnology firm dedicated to developing biological treatments for neurodegenerative diseases, has recently announced the initiation of the ALSTARS Trial. This Phase 2 clinical trial aims to evaluate both the efficacy and safety of COYA 302, specifically targeting Amyotrophic Lateral Sclerosis (ALS).

Overview of the ALSTARS Trial

The ALSTARS Trial is designed as a well-powered, randomized, multi-center, double-blind, placebo-controlled study. Spanning 24 weeks, this research will engage approximately 120 participants diagnosed with ALS at around 25 clinical centers across the United States and Canada. Those who complete the initial 24-week treatment phase will be invited to enter an additional 24-week extension trial, during which all participants will receive COYA 302.

The trial will involve randomization, with candidates assigned to receive one of two doses of COYA 302 or a placebo. This structure aims to provide clear insights into the drug's efficacy and safety over the study duration.

Significance of COYA 302

COYA 302 represents a promising biologic combination therapy that employs a dual immunomodulatory approach. It is designed to enhance the function of regulatory T cells (Tregs), which play a crucial role in managing immune responses and inflammation. By stimulating the proliferation and activity of these cells, COYA 302 aims to reduce the inflammatory processes that underpin neurodegenerative conditions, including ALS.

Fred Grossman, the Chief Medical Officer at Coya Therapeutics, emphasized that the ALSTARS Trial marks a leap towards innovative ALS therapies. He expressed optimism regarding the unique mechanism of COYA 302 in potentially addressing the critical unmet needs faced by ALS patients and their families. The aim is not just to test the product but also to understand its long-term implications on patient health and quality of life.

Understanding Amyotrophic Lateral Sclerosis

ALS, commonly referred to as Lou Gehrig's Disease, is a rare yet progressive neurological condition that deteriorates motor neurons in both the brain and spinal cord, leading to severe impairment of voluntary muscle control. Approximately 20,000 individuals are currently living with ALS in the U.S., with around 5,000 new diagnoses each year. The disease progresses relentlessly, typically resulting in significant physical decline over time, with most patients facing significant challenges in mobility and communication, ultimately leading to respiratory failure.

Despite the profound impact of ALS, treatment options remain vastly limited, and existing medications provide only minimal benefit. The launch of COYA 302 presents a potential shift in therapeutic strategies for dealing with this debilitating disease.

Future Directions

Coya Therapeutics aims to continue expanding its research footprint in the ALS space and will present the findings of the ALSTARS Trial at the NEALS Educational Webinar on September 29, 2025. Interested parties can find more information about the study, including participant eligibility and clinical sites, by visiting ClinicalTrials.gov.

With innovative treatments like COYA 302, Coya Therapeutics is positioned to contribute significantly to the ongoing search for effective therapies against ALS, leading individuals and families toward brighter horizons in managing this challenging condition.