Coya Therapeutics Launches the ALSTARS Trial, a Phase 2 Clinical Study to Assess the Efficacy and Safety of COYA 302 in Amyotrophic Lateral Sclerosis
Rhea-AI Summary
Coya Therapeutics (NASDAQ:COYA) has launched the ALSTARS Trial, a Phase 2 clinical study evaluating COYA 302 for treating Amyotrophic Lateral Sclerosis (ALS). The trial is designed as a randomized, multi-center, double-blind, placebo-controlled study spanning 24 weeks.
Key trial details include:
- Enrollment of 120 ALS participants across approximately 25 centers in the US and Canada
- Two different COYA 302 dosing groups plus placebo
- Additional 24-week blinded extension period where all participants receive COYA 302
The study focuses on COYA 302's mechanism of enhancing regulatory T cell function in patients with neurodegenerative disorders.
Positive
- Well-designed Phase 2 trial with robust methodology (randomized, multi-center, double-blind, placebo-controlled)
- Significant trial size with 120 participants across 25 centers in US and Canada
- 24-week extension period offering continued treatment access to all participants
Negative
- Early-stage Phase 2 trial with uncertain outcomes
- Results not expected in immediate term due to 48-week total study duration
Insights
Coya launches phase 2 ALS trial for COYA 302, demonstrating progression in clinical development but still years from potential approval.
Coya Therapeutics has initiated the ALSTARS trial, a Phase 2 clinical study evaluating COYA 302 in 120 patients with Amyotrophic Lateral Sclerosis (ALS) across approximately 25 centers in the US and Canada. The study design shows methodological strength with its randomized, multi-center, double-blind, placebo-controlled structure over 24 weeks, followed by a 24-week blinded extension where all participants will receive the drug.
The trial's design reflects regulatory rigor with two different dosing arms plus placebo, allowing for dose-response assessment critical for later-stage development. The extension phase, where all patients receive active treatment, suggests confidence in the drug's safety profile while providing early compassionate access for placebo participants.
COYA 302's mechanism targeting regulatory T cell (Treg) function is noteworthy as neuroinflammation is increasingly recognized as a key pathological process in ALS. This approach differs from other ALS treatments that primarily target glutamate excitotoxicity or oxidative stress.
For context, Phase 2 studies represent an intermediate development stage - beyond initial safety testing but before pivotal Phase 3 trials required for approval. Most compounds fail in Phase 2, so while this progress is positive, COYA 302 still faces significant hurdles. The trial's participant size (120) is substantial for Phase 2 but would likely need expansion in Phase 3. Even with success, regulatory approval remains at least 2-3 years away, assuming accelerated pathways are granted for this high-unmet-need indication.
The ALSTARS Trial is a well powered randomized, multi-center, double-blind, placebo-controlled, 24-week study of COYA 302 in people with Amyotrophic Lateral Sclerosis (ALS)
Patients completing the initial 24-week treatment will be invited to participate in a 24-week blinded extension period, during which all participants will receive COYA 302
The ALSTARS Trial will enroll 120 ALS participants at approximately 25 centers in
Eligible study participants will be randomized to receive one of two different doses of COYA 302 or placebo in this 24-week, double-blind study. Participants who complete the initial placebo-controlled phase will be invited to enroll in an additional 24-week blinded extension to assess the long-term safety and efficacy of COYA 302. During this extension, all participants will receive COYA 302 at one of the two prespecified doses.
Study details, including eligibility criteria and current study locations, can be found here. Additional locations will continue to be added. The study will be presented on September 29, 2025, during the NEALS Educational Webinar by Dr. James Berry, MD, MPH and registration can be found here.
Fred Grossman, Chief Medical Officer stated "The launch of the ALSTARS Trial represents a significant milestone in our mission to develop innovative therapies for patients with ALS. We believe COYA 302's unique mechanism of enhancing regulatory T cell number and function offers a promising new approach towards developing a potential therapy 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."
About COYA 302
COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 comprises proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig and is being developed for subcutaneous administration for the treatment of patients with ALS. These mechanisms may have additive or synergistic effects.
COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency.
About Amyotrophic Lateral Sclerosis
Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, is a rare neurological disease that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement. About 20,000 people live with ALS in
- Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725. doi: 10.1212/WNL.0000000000000951.
- National Institutes of Health (NIH) Website (https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als), accessed on January 4, 2023.
About Coya Therapeutics, Inc.
Headquartered in
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
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