US FDA Accepts Coya Therapeutics' Application for Investigational ALS Drug

Coya Therapeutics, a clinical-stage biotechnology company, has announced that the US FDA has accepted its application for investigational ALS drug. The company's initial developmental programs focus on neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases. Its candidate pipeline includes ex vivo and in vivo approaches, with product candidates based on three therapeutic modalities: Treg-enhancing biologics (300 Series), Treg-derived exosomes (200 Series), and autologous Treg cell therapy (100 Series).

Houston, TX - July 2, 2025 - Coya Therapeutics, Inc. (NASDAQ: COYA), a clinical-stage biotechnology company, has announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for COYA 302. This approval marks a significant milestone in the company's efforts to develop a treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

COYA 302 is an investigational biologic combination therapy with a dual immunomodulatory mechanism of action. It aims to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress inflammation produced by activated monocytes and macrophages. The therapy is designed for subcutaneous administration and is part of Coya's 300 Series of Treg-enhancing biologics.

The FDA's acceptance of the IND application enables Coya to initiate a Phase 2 multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of COYA 302 in ALS patients. The study will be conducted in collaboration with Dr. Reddy's Laboratories Ltd. (DRL), which has a strategic partnership with Coya. This milestone also triggers a $4.2 million milestone payment to Coya from DRL.

Amyotrophic lateral sclerosis (ALS) is a rare neurological disease that affects motor neurons, leading to progressive muscle weakness and atrophy. Currently, there is no cure for ALS, and approved treatments provide limited benefit. The disease is progressive, with symptoms worsening over time, and the average life expectancy is three to five years from symptom onset.

Coya Therapeutics focuses on developing proprietary treatments that target systemic inflammation and neuroinflammation by leveraging the biology of regulatory T cells. The company's pipeline includes ex vivo and in vivo approaches, with product candidates based on Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy.

This development is a significant step forward in the company's mission to address unmet medical needs in neurodegenerative and inflammatory diseases. Coya's CEO, Arun Swaminathan, stated, "The FDA's acceptance of this IND marks a pivotal moment in Coya's journey. We are now preparing to initiate a well-powered, well-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of COYA 302 in patients with ALS."

Coya's strategic partnership with DRL further underscores the strong scientific and strategic rationale behind their collaboration. Milan Kalawadia, CEO of North America at DRL, expressed, "We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study. This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energized by the potential of moving a step closer to offering a treatment for patients living with ALS."

References:
[1] https://www.prnewswire.com/news-releases/coya-therapeutics-announces-fda-acceptance-of-investigational-new-drug-ind-application-for-coya-302-for-the-treatment-of-amyotrophic-lateral-sclerosis-als-302537194.html