Coya Therapeutics has further advanced towards clinical trials on its potential therapy for the treatment of amyotrophic lateral sclerosis (ALS).
The company announced that it has held successful pre-IND (Investigational New Drug) and Type C meetings with the US Food and Drug Administration (FDA).
It has sought advice from the Agency in order 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 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.
Dr Fred Grossman, president and chief medical officer of Coya said: “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.”
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.
Howard H. Berman, Ph.D., CEO of Coya, added: “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 securing Coya a cash runway into 2026 and through completion of this study, we believe that we are in a position to execute and deliver value to patients and shareholders.”
