FDA Misses IND Deadline for Coya’s ALS Asset, Citing Resource Constraints

The FDA missed its July 30 review deadline for Coya Therapeutics' investigational new drug (IND) application for its ALS therapy due to a lack of resources and current workload pressures, as indicated in a recent Securities and Exchange Commission filing by the company1.

Coya was informed on July 29 that the FDA would not meet the initial review goal, promising a decision instead by or before August 291.

The IND application is essential for Coya to commence a phase 2 clinical trial for COYA 302, a biologic asset dubbed a "pipeline in a product," combining LD IL-2 (COYA 301) and CTLA4-Ig, targeted at ALS and other neurodegenerative diseases1.

The delay affects Coya at an early development stage, prolonging the period before it can begin human studies and impacting the company’s cash runway, as the clinical trial remains on hold1.

This episode is part of a broader pattern, with the FDA also missing recent deadlines on other high-profile drug decisions, reflecting ongoing agency resource constraints1.

Sources:

1. https://www.fiercebiotech.com/biotech/fda-misses-ind-deadline-coyas-als-asset-cites-lack-resources