The FDA has accepted the Investigational New Drug (IND) application for COYA 302, a therapy being developed by the biotechnology company Coya Therapeutics which focuses on treating neurodegenerative disorders. This crucial acceptance allows the company to move forward with a Phase 2 clinical study to evaluate the safety and effectiveness of the drug in patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. This is a significant milestone for Coya Therapeutics, as highlighted by CEO Arun Swaminathan, who expressed gratitude to the ALS community for their support of the program. The acceptance also triggers a $4.2 million milestone payment to Coya from Dr. Reddy's Laboratories (DRL), a strategic partner in the development of COYA 302.

COYA 302 is an experimental biologic combination therapy designed with a dual mechanism to enhance the function of anti-inflammatory regulatory T cells and suppress inflammation caused by other immune cells. The drug is administered subcutaneously and leverages a combination of low-dose interleukin-2 (LD IL-2) and CTLA-4 Ig, which are believed to have a synergistic effect.

ALS is a rare and progressive neurological disease that affects the motor neurons that control voluntary muscle movement, leading to muscle weakness, atrophy, and eventually, respiratory failure, with most patients dying within three to five years of symptom onset. With no cure and limited benefits from existing treatments, the need for new therapies is urgent. Coya Therapeutics' work on COYA 302 is part of its broader focus on developing treatments that leverage the biology of regulatory T cells to combat systemic inflammation and neuroinflammation in conditions where these cells are dysfunctional.