After a nearly month-long delay, the U.S. Food and Drug Administration (FDA) has approved Coya Therapeutics’ investigational new drug (IND) application for its amyotrophic lateral sclerosis (ALS) candidate, COYA 302.
The clearance allows Coya to move forward with a multicenter phase 2 clinical trial in ALS patients. “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,” said Arun Swaminathan, Ph.D., Chief Executive Officer of Coya Therapeutics, in an August 25 statement.
The FDA’s decision also triggered a $4.2 million milestone payment to Coya from Dr. Reddy’s Laboratories (DRL). The India-based pharmaceutical company licensed the rights to commercialize COYA 302 for ALS in the U.S., U.K., Canada, and the European Union in late 2023. Milan Kalawadia, Chief Executive Officer, North America at DRL, said the company viewed the advancement of COYA 302 as reinforcing the scientific and strategic rationale for its collaboration with Coya and expressed support as the program enters its next phase.
COYA 302 is a proprietary biologic therapy that combines low-dose interleukin-2 (LD IL-2), also known as COYA 301, with CTLA-4 Ig. The therapy is designed for subcutaneous administration and aims to enhance the anti-inflammatory function of regulatory T cells (Tregs) while suppressing inflammation from activated monocytes and macrophages. According to Coya, these mechanisms may work additively or synergistically.
Coya is advancing COYA 302 in several neurodegenerative diseases, including ALS, Parkinson’s disease, dementia, and Alzheimer’s disease. The company, based in Houston, focuses on biologics that target Treg function in patients with neurodegenerative conditions.
The IND decision comes after an earlier setback. On July 29, the FDA informed Coya that it would miss the July 30 deadline for a decision on the IND due to limited resources. A revised decision date was set for August 29. The eventual clearance was granted four days before that deadline.
Coya’s delay followed a similar situation with Neurizon, an Australian biotechnology company developing ALS candidate NUZ-001. Neurizon was expecting an FDA update this month on whether a clinical hold would be lifted, but was later informed that a decision would not be made until October 3.
The FDA has postponed or missed multiple regulatory deadlines in recent years, including those for Regenxbio’s Hunter syndrome gene therapy, Stealth Therapeutics’ rare disease treatment, KalVista Pharmaceuticals’ angioedema therapy, and Omeros’ transplant drug. This has occurred despite Commissioner Marty Makary, M.D., stating in June that the agency would meet its deadlines.
With FDA clearance in hand, Coya now plans to move forward with its phase 2 study of COYA 302 in ALS patients, while continuing to develop the therapy for additional neurodegenerative indications.
