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Coya Therapeutics Announces Successful Pre-IND and Type C Meetings with the FDA to Advance the Development of COYA 302 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Coya has a clear path towards submission of the IND application to the FDA in the second quarter of 2024, with a planned initiation of a well-controlled,
About this update from Coya Therapeutics, Inc.
[{"type":"text","content":"\n\nCoya has a clear path towards submission of the IND application to the FDA in the second quarter of 2024, with a planned initiation of a well-controlled, double-blind clinical trial of COYA 302 in patients with ALS upon acceptance of the IND\n\n\n\n HOUSTON--(BUSINESS WIRE)--\nCoya Therapeutics, Inc. (“Coya”), a clinical-stage biotechnology company today announced successful meetings with the U.S. Food and Drug Administration (FDA) following a pre-IND (Investigational New Drug) 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.\n\n\nCOYA 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.\n\n\nAs a result of the interactions with the FDA, Coya has obtained constructive feedback and has reached alignment on key areas involved in the development of COYA 302, including CMC (chemistry, manufacturing, and controls), 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.\n\n\nDr. Fred Grossman, President and Chief Medical Officer of Coya stated, “This important feedback allows us to advance our development program in ALS with a planned double-blind controlled study, with the potential for bringing forward a much-needed therapy for ALS patients.”\n\n\nHoward H. Berman, Ph.D., CEO of Coya stated: “We believe that gaining alignment with FDA through multiple regulatory meetings on the path to filing an IND in Q2, 2024 is an important next step in advancing the program in patients with ALS. With the recent out-licensing transaction and private placement transaction securi...