ALS Drug Targeting Immune Regulation Completes Phase 2/3 Enrollment of 120 Patients
Coya Therapeutics finishes enrolling 120 participants for COYA 302, a low-dose IL-2 and CTLA-4 Ig combo aimed at slowing ALS progression.
Summary
Coya Therapeutics has completed enrollment of 120 participants in the Phase 2/3 ALSTARS trial testing COYA 302 in people with ALS. The drug combines low-dose interleukin-2 and CTLA-4 Ig to boost regulatory T cell activity and reduce neuroinflammation — a key driver of ALS progression. The trial is randomized, double-blind, and placebo-controlled, with participants assigned to one of two COYA 302 doses or placebo for 24 weeks, followed by a 24-week active-treatment extension. The primary measure is change in functional disability using the standard ALS Functional Rating Scale. Topline results are expected in early Q2 2027. A global commercialization partnership with Dr. Reddy's is already in place.
Detailed Summary
ALS, or amyotrophic lateral sclerosis, is a relentlessly progressive neurodegenerative disease with very limited treatment options. One emerging theory holds that immune dysregulation — specifically a failure of regulatory T cells to suppress runaway neuroinflammation — accelerates motor neuron death. COYA 302 is designed to correct this by combining low-dose interleukin-2, which preferentially expands regulatory T cells, with CTLA-4 Ig, an immune checkpoint agent that further dampens inflammatory signaling.
Coya Therapeutics has now completed enrollment of the planned 120 participants in the multicenter, randomized, double-blind, placebo-controlled ALSTARS Phase 2/3 trial. Participants are allocated 1:1:1 to one of two pre-specified COYA 302 dosing regimens or placebo. The 24-week double-blind phase is followed by a 24-week blinded active-treatment extension, providing up to 48 weeks of longitudinal data per participant. Additional eligible candidates already in active screening will also be permitted to enroll.
The primary endpoint is change in the ALS Functional Rating Scale-Revised total score from baseline to Week 24 — a validated measure of disease-related functional decline covering speech, swallowing, limb function and breathing. Topline data are expected in early Q2 2027, which would give the field a substantive signal on whether immune-modulation can meaningfully slow ALS progression.
The commercial foundation is already taking shape. Coya holds an exclusive collaboration with Dr. Reddy's for global rights outside Japan, South America, and Mexico, while retaining U.S. development and regulatory responsibility. This arrangement suggests confidence in the platform beyond a single indication.
For longevity-focused readers, the trial is notable because neuroinflammation and regulatory T cell dysfunction are implicated not only in ALS but in broader age-related neurodegeneration. If COYA 302 demonstrates efficacy here, the immune-modulation strategy may have wider relevance to aging neurobiology.
Key Findings
- 120 participants fully enrolled in Phase 2/3 ALSTARS trial; topline data expected early Q2 2027.
- COYA 302 combines low-dose IL-2 and CTLA-4 Ig to expand regulatory T cells and suppress neuroinflammation.
- Trial runs 24-week double-blind phase plus 24-week active-treatment extension for up to 48 weeks of data.
- Primary endpoint is change in ALS Functional Rating Scale-Revised score from baseline to Week 24.
- Dr. Reddy's partnership secures global commercialization rights outside Japan, South America, and Mexico.
Methodology
This is a corporate news report summarizing a clinical trial milestone, not a peer-reviewed publication. The source is Longevity.Technology, a credible longevity-focused outlet. Evidence basis is a company press release; no interim efficacy or safety data have been disclosed.
Study Limitations
Data presented are from a company announcement, not a peer-reviewed publication, and no efficacy or safety results have been released yet. The trial has not reported interim outcomes, so the benefit of COYA 302 over placebo remains unproven. Readers should verify endpoint definitions, patient selection criteria, and statistical analysis plans from the primary clinical trial registry listing.
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