Coya Therapeutics has initiated the blinded extension phase of the ALSTARS trial, evaluating the safety and efficacy of COYA 302 as a potential treatment for adults with amyotrophic lateral sclerosis (ALS).
The Phase II study will be conducted at 20 to 25 locations across Canada and the US.
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The trial design includes an initial 24-week placebo-controlled, double-blind phase, after which patients can enter the blinded extension period.
Participants who complete the initial stage continue their allocated regimen while those originally assigned to placebo are re-randomised to receive one of two specified dosing regimens of COYA 302 for up to an additional 24 weeks.
This approach allows for the collection of up to 48 weeks of data on COYA 302.
Coya Therapeutics president and chief medical officer Fred Grossman said: “We are very pleased with the progress of this important clinical study of COYA 302 in people with ALS that we hope may ultimately lead to a transformational new treatment.
“We would like to thank the patients, families, and caregivers for their ongoing support and contribution to the ALSTARS Trial.”
COYA 302 is an investigational, proprietary biologic combination therapy designed to boost regulatory T cell (Treg) function and reduce inflammation driven by monocytes and macrophages.
The combination consists of low-dose interleukin-2 (LD IL-2) and DRL_AB, a biosimilar candidate for abatacept.
The double-blind period randomly assigns participants in a 1:1:1 ratio to receive either one of the two dosing regimens of COYA 302 or placebo.
Key assessments in the trial include standard ALS clinical outcome measures such as the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), and slow vital capacity (SVC), as well as neurological assessments.
The study will also monitor biomarkers and safety through routine assessments and adverse event tracking.
Coya Therapeutics focuses on developing proprietary therapeutic platforms targeting Treg dysfunction in neurodegenerative, metabolic, and autoimmune diseases.
Its product candidate pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.
In September 2025, Coya Therapeutics completed participant enrolment of an investigator-initiated, open-label trial evaluating low-dose IL-2 and CTLA4-Ig combination treatment in subjects with mild to moderate frontotemporal dementia.
