Coya Therapeutics, Inc. (NASDAQ: COYA) announced that its planned Phase 2 clinical trial of COYA 302 for amyotrophic lateral sclerosis (ALS) has been accepted as a NEALS-Affiliated Trial. NEALS, the Northeast Amyotrophic Lateral Sclerosis Consortium, is the largest ALS research network in the world and includes more than 150 research centers. The consortium’s mission is to accelerate the development of treatments for people living with ALS.
The recognition follows the recent FDA acceptance of Coya’s investigational new drug (IND) application for COYA 302. The company expects to initiate its Phase 2 study in the fourth quarter of 2025. Details of the study will be presented on September 29, 2025, during a NEALS Educational Webinar by Dr. James Berry of Massachusetts General Hospital, a leading ALS investigator.
As a NEALS-affiliated study, the COYA 302 trial will benefit from NEALS’ established clinical infrastructure.
“We are honored that our COYA 302 trial has been recognized by NEALS and look forward to working closely with their network of leading ALS investigators, clinical centers, and patient outreach groups,” said Dr. Fred Grossman, President and Chief Medical Officer. “This important affiliation further advances our commitment to advancing new treatments for people living with ALS.”
COYA 302 is an investigational biologic combination therapy designed to enhance the function of regulatory T cells and reduce damaging inflammation in ALS patients. It consists of low-dose interleukin-2 and CTLA-4 Ig and is being developed for subcutaneous administration.
ALS, also known as Lou Gehrig’s disease, is a rare and progressive neurodegenerative disorder that leads to loss of motor neuron function, muscle weakness, and eventual respiratory failure. Roughly 20,000 people in the U.S. are living with the disease, with about 5,000 new cases diagnosed annually. Current treatments provide only limited benefit, and most patients survive three to five years after symptom onset.
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