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Coya Completes ALSTARS Trial Enrollment; Data Due Early Q2 2027

Coya Therapeutics finishes enrolling 120 participants in its Phase 2/3 ALSTARS trial of COYA 302 for ALS, with topline data expected in early Q2 2027.

By Muhamed Porić

October 10, 2026 at 10:11 AM

Photo by Markus Spiske on Pexels

Coya Therapeutics has completed full enrollment of 120 participants in its Phase 2/3 ALSTARS trial evaluating COYA 302 for amyotrophic lateral sclerosis, keeping topline data on track for early Q2 2027.

The milestone marks the conclusion of primary participant intake for the randomized, placebo-controlled study, designated as NCT07161999, which tests the efficacy and safety of the combination therapy in ALS patients. According to a StockTitan report, individuals currently engaged in active screening will still be permitted to enroll in the trial if they meet eligibility criteria.

"Having achieved the planned enrollment, ALSTARS has reached an important milestone as we advance toward the first randomized, placebo-controlled efficacy data for COYA 302 in ALS," said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya.

Treatment Phase and Data Timeline

The trial centers on a 24-week double-blind treatment phase designed to measure functional outcomes and disease progression in patients receiving COYA 302. Topline results from this core evaluation period are anticipated in early Q2 2027, providing the first major randomized dataset for the asset.

"We are pleased with the continued progress of the COYA 302 ALS program and our collaboration with Coya," said Erez Israeli, Chief Executive Officer, at Dr. Reddy’s Laboratories Ltd.

Partnership and Commercialization Structure

The clinical program is backed by an exclusive collaboration established in December 2023 between Coya Therapeutics and Dr. Reddy's Laboratories. Under the terms of that agreement, Dr. Reddy's secured exclusive commercialization rights for COYA 302 in the treatment of ALS across global markets, excluding Japan, South America, and Mexico.

Market Response and Equity Valuation

In public markets, shares of Coya Therapeutics Inc. (NASDAQ: COYA) traded at $4.95, down 0.80% from a previous close of $4.99, as of 20:00 UTC on October 9, 2026, according to Finnhub market data. The clinical-stage biotechnology company focuses on regulatory T cell-based therapies for neurodegenerative and autoimmune diseases.

What Is at Stake for ALS Therapeutics

Amyotrophic lateral sclerosis remains a rapidly progressive and fatal neurodegenerative disease with limited therapeutic options capable of altering disease trajectory. The upcoming readout in 2027 will serve as a critical clinical and regulatory test for combination biologic approaches targeting neuroinflammation, carrying significant implications for both Coya's clinical pipeline and its commercial partnership with Dr. Reddy's.

Coya TherapeuticsBiotechClinical TrialsALSDr. Reddy's Laboratories
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Muhamed Porić

Founder and Editor of Embers.

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