16 September 2026

Phase 2/3 study evaluates whether COYA 302 helps preserve daily function

• ALS is a progressive neurodegenerative disorder where motor neurons degenerate, driven partly by harmful, uncontrolled nervous system inflammation.
• Key symptoms involve a gradual loss of physical function, including difficulties with speaking, swallowing, walking, and breathing.
• The Phase 2/3 ALSTARS trial is evaluating COYA 302 to slow disease progression and preserve daily function.

Coya Therapeutics is approaching full enrollment in its main clinical trial for COYA 302, an experimental therapy for amyotrophic lateral sclerosis (ALS), having signed on its 100th participant.

The Phase 2/3 ALSTARS trial (NCT07161999) aims to recruit 120 adults with ALS across sites in the U.S. and Canada. Coya expects to reach full enrollment within weeks and plans to report top-line results in April or May of next year.

“Enrollment of the 100th participant in the ALSTARS trial represents a critical milestone for Coya and brings us closer to completing this important Phase 2/3 study,” Fred Grossman, president and chief medical officer at Coya, said in a company press release.

How the ALSTARS trial works

The study is open to adults ages 18 to 80 who had their first symptoms no more than 28 months prior and meet specific progression criteria. Participants may be taking the approved ALS treatments Rilutek (riluzole), Radicava (edaravone), and/or Qalsody (tofersen), provided they are on a stable regimen.

Participants will be randomly assigned to receive one of two doses of COYA 302 or a placebo for about six months. After this initial period, all participants can enter an extension phase during which they receive treatment with COYA 302.

The trial’s primary goal is to evaluate whether COYA 302 slows disease progression better than a placebo. Researchers will measure changes using the Revised ALS Functional Rating Scale, a standardized tool that assesses daily abilities such as speaking, swallowing, walking, and breathing.

“We are deeply grateful to the patients, caregivers, investigators, and clinical site teams whose participation and commitment continue to make the ALSTARS trial possible,” Grossman said. “We look forward to topline data and believe that, if positive, COYA 302 has the potential to significantly alter the course of this devastating disease and offer new hope to people living with ALS and their families.”

ALS is a progressive disorder in which motor neurons, the specialized nerve cells that govern movement, gradually degenerate and die. While the underlying causes of ALS remain unknown, scientists believe harmful, uncontrolled inflammation in the nervous system helps to drive disease progression.

COYA 302 is an under-the-skin injection combining two active biologic molecules: low-dose interleukin-2 (IL-2) and CTLA4-Ig (abatacept). These components work together to dampen inflammation.

In an early Phase 1 trial, patients who took COYA 302 experienced a slower rate of physical decline than their pre-study progression rate. The U.S. Food and Drug Administration recently granted COYA 302 fast track designation, which aims to speed the development of therapies that may fill unmet needs in the care of serious disorders.rest

Source: ALS News Today