Coya hits 100 patients in Phase 2/3 ALS trial
Rhea-AI Filing Summary
Coya Therapeutics, Inc. (COYA) reports that the 100th patient has been enrolled in its ongoing Phase 2/3 ALSTARS Trial (NCT07161999) evaluating COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, for the treatment of amyotrophic lateral sclerosis (ALS).
The company plans to enroll approximately 120 participants, randomized 1:1:1 to two COYA 302 dosing regimens or placebo over a 24-week double-blind phase, followed by a 24-week blinded active-treatment extension, providing up to 48 weeks of COYA 302 data. Based on current trends, Coya anticipates completing enrollment in time to report topline data in early Q2 2027. The primary endpoint is change in disease severity from baseline to Week 24 using ALSFRS-R, with additional objectives including efficacy, safety, tolerability, biological activity and biomarker levels.
Positive
- None.
Negative
- None.
Insights
Analyzing...
8-K Event Classification
Item 8.01 — Other Events
1 item
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Key Figures
Patients enrolled: 100 patients
Planned enrollment: 120 participants
Randomization ratio: 1:1:1
+3 more
6 metrics
Patients enrolled
100 patients
100th patient enrolled in the Phase 2/3 ALSTARS Trial as of September 15, 2026
Planned enrollment
120 participants
Approximately 120 subjects planned for randomization in the ALSTARS Trial
Randomization ratio
1:1:1
Participants randomized to two COYA 302 dosing regimens or placebo
Double-blind treatment duration
24 weeks
Initial placebo-controlled double-blind treatment phase
Maximum COYA 302 exposure
48 weeks
24-week double-blind phase plus 24-week blinded active-treatment extension
Topline data timing
Early Q2 2027
Anticipated reporting of topline ALSTARS Trial data
Key Terms
Phase 2/3, double-blind, placebo-controlled, Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), +1 more
5 terms
Phase 2/3 medical
"The ALSTARS Trial is a Phase 2/3, randomized, multi-center, double-blind"
A phase 2/3 trial is a combined clinical study that first evaluates how well a treatment works and the best dose, then expands into a larger test to confirm those results and safety. For investors, it matters because moving into a phase 2/3 signals that an experimental therapy has shown initial promise and will be tested at scale, which can materially change the odds and timeline for regulatory approval and commercial potential.
double-blind medical
"double-blind, placebo-controlled study designed to evaluate the efficacy"
A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.
placebo-controlled medical
"double-blind, placebo-controlled study designed to evaluate the efficacy"
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) medical
"measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised"
Fast Track designation regulatory
"potential benefits associated with the FDA’s Fast Track designation for COYA 302"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What milestone did Coya Therapeutics (COYA) announce in its ALSTARS ALS trial?
Coya Therapeutics announced enrollment of the 100th patient in its Phase 2/3 ALSTARS Trial evaluating COYA 302 for ALS, marking substantial progress toward the planned enrollment of approximately 120 participants in this randomized, double-blind, placebo-controlled study.
When does Coya Therapeutics (COYA) expect topline data from the ALSTARS Trial?
Coya Therapeutics expects to report topline data in early Q2 2027, assuming full enrollment of 120 participants is completed as anticipated based on current enrollment trends in the Phase 2/3 ALSTARS Trial.
How is the ALSTARS Phase 2/3 trial for COYA 302 designed?
The ALSTARS Trial plans to enroll approximately 120 subjects, randomized 1:1:1 to two dosing regimens of COYA 302 or placebo for a 24-week double-blind phase, followed by a 24-week blinded active-treatment extension providing up to 48 weeks of COYA 302 data.
What is the primary endpoint of Coya Therapeutics’ ALSTARS ALS trial?
The primary endpoint is the change in disease severity over time, measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) total score from baseline to Week 24, comparing COYA 302 treatment arms with placebo.
What are the main objectives of the COYA 302 ALSTARS Trial for COYA?
The ALSTARS Trial objectives include evaluating efficacy, safety and tolerability of COYA 302 in ALS, as well as assessing its biological activity and biomarker levels over up to 48 weeks of treatment exposure in enrolled patients.
AI-generated analysis. How Rhea-AI works. Not financial advice.
