Coya Therapeutics, a clinical-stage biotechnology company developing Treg-enhancing biologics for neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COYA 302 for the treatment of amyotrophic lateral sclerosis (ALS).

With the IND now active, Coya plans to initiate a multicenter Phase 2 trial to evaluate the safety and efficacy of COYA 302, a proprietary immunomodulatory biologic combination therapy.

“The FDA’s acceptance of this IND is a pivotal moment for Coya as we prepare to advance COYA 302 into a well-powered Phase 2 study in ALS,” said Arun Swaminathan, Chief Executive Officer of Coya Therapeutics.

As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya.