Health Canada accepted Coya Therapeutics’ Clinical Trial Application for the COYA 302 ALSTARS study on 23 December 2025, clearing the company to activate clinical sites across Canada and broaden enrollment for its Phase 2 investigation of a Treg‑enhancing biologic in amyotrophic lateral sclerosis (ALS). The approval marks a key regulatory milestone that removes a major barrier to recruiting Canadian patients and speeds the collection of primary and secondary endpoint data.
The COYA 302 combination therapy pairs low‑dose interleukin‑2 with CTLA‑4 Ig to boost regulatory T‑cell function and dampen pro‑inflammatory activity. The ALSTARS trial (ClinicalTrials.gov identifier NCT07161999) is designed to evaluate safety, tolerability, and efficacy of this novel approach in ALS patients, a disease with a high unmet need and limited disease‑modifying options.
By adding Canadian sites, Coya can increase the trial’s sample size, improve geographic diversity, and shorten the enrollment timeline. A larger, more representative cohort enhances the statistical power of the study and accelerates the generation of data that will inform regulatory submissions and potential future approvals.
Coya’s financial position supports this expansion. As of 30 September 2025, the company held $28.1 million in cash and equivalents and had recently closed a $23.0 million public offering, extending its runway into the second half of 2027. The partnership with Dr. Reddy’s Laboratories (DRL) has already yielded a $4.2 million milestone payment following the FDA’s acceptance of the IND for COYA 302 in August 2025, underscoring the commercial and financial backing behind the program.
Chief Medical Officer Dr. Fred Grossman said, “The activation of Canadian sites is an important step forward for the ALSTARS Trial that we believe will further enhance recruitment of this important study currently underway in the United States. We look forward to working with the Canadian ALS centers, with the goal of potentially delivering new, safe and effective treatments for ALS.” The comment highlights the company’s focus on expanding access and accelerating progress toward a potential ALS therapy.
Health Canada’s CTA acceptance follows a standard review process that typically takes about 30 days. The decision confirms that the application meets regulatory requirements for participant protection, drug quality, and trial conduct, thereby removing a critical regulatory hurdle for the study’s Canadian phase.
ALS remains a devastating neurodegenerative disease with a median survival of 3–5 years after diagnosis and no curative treatments. A therapy that can modulate the immune system to slow disease progression would represent a significant advance. Coya’s Treg‑enhancing strategy offers a novel mechanism that could alter the disease trajectory, making the regulatory approval of the Canadian trial sites a pivotal moment for the company’s pipeline.
The expansion into Canada positions Coya to generate robust clinical data that could support future regulatory submissions and bring a potentially transformative treatment to patients worldwide. The milestone also reinforces investor confidence in the company’s financial health and strategic partnerships, setting the stage for the next phases of development.
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