Coya Therapeutics announced that the FDA has accepted its Investigational New Drug (IND) application for COYA 302. This proprietary immunomodulatory biologic combination therapy is being developed for the treatment of patients with amyotrophic lateral sclerosis (ALS).
Arun Swaminathan, Chief Executive Officer, added: "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. We are grateful to the ALS community for their continued support of this important program."
Milan Kalawadia, Chief Executive Officer, North America, at Dr. Reddy's Laboratories Ltd. ("DRL") stated, "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, also known as Lou Gehrig's disease."
The approval of the IND by the FDA triggers a $4.2 million milestone payment to Coya from DRL.
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