Coya announces pre-IND meeting, Type C meeting with FDA for COYA 302

Coya Therapeutics announced meetings with the FDA following a pre-IND meeting and a Type C meeting intended to seek advice from the Agency to reach alignment on multiple aspects of the planned development program in support of an IND application of COYA 302 for the treatment of ALS. COYA 302 is a dual-mechanism investigational biologic combination therapy comprised of proprietary low dose IL-2 and fusion protein CTLA-4 Ig. Low dose IL-2 enhances anti-inflammatory Treg function and numbers while the fusion protein CTLA-4 Ig is intended to suppress pro-inflammatory cell function enabling potentially synergistic mechanisms in modulating inflammatory pathways. As a result of the interactions with the FDA, Coya has obtained feedback and has reached alignment on key areas involved in the development of COYA 302, including CMC, preclinical and clinical activities for the IND application. The results of the regulatory meetings constitute a significant step towards the submission of the IND application to the FDA in the second quarter of 2024, and initiation of a well-controlled, double-blind clinical trial of COYA 302 in patients with ALS upon acceptance of the IND. Coya plans to continue working closely with the FDA over the course of the COYA 302 development program.