After a nearly monthlong delay, the FDA has approved the investigational new drug application for Coya Therapeutics’ amyotrophic lateral sclerosis asset.
With the FDA’s go-ahead, Coya plans to launch a multicenter phase 2 trial of COYA 302 in patients with ALS, CEO Arun Swaminathan, Ph.D., said in an Aug. 25 release.
The green light also triggered a $4.2 million milestone payment to Coya from Dr. Reddy's Laboratories, an India-based drugmaker that licensed the right to commercialize COYA 302 for ALS in the U.S., U.K., Canada and European Union in late 2023.
COYA 302 combines Coya’s LD IL-2 candidate, called COYA 301, with a CTLA4-Ig, and Coya is pursuing the asset in ALS, dementia, Parkinson’s disease and Alzheimer’s disease.
News of a delay from the FDA came on July 29, with the agency alerting Coya that it would miss the July 30 deadline for a decision on the IND application due to limited resources. Coya’s revised decision date was Aug. 29.
Coya’s delay was followed not long after by a similar postponement for Neurizon. The Australian biotech was expecting to hear this month whether its ALS candidate, NUZ-001, would have a clinical hold lifted. Instead, the FDA told the company that its decision would come down by Oct. 3.
The FDA has delayed or missed numerous regulatory deadlines since the beginning of President Donald Trump’s second term, with potential culprits being increased scrutiny of biologics like vaccines and gene therapies and a slew of staffing cuts. Most recently, the regulator extended the PDUFA date for Regenxbio’s Hunter syndrome gene therapy.
The FDA has also delayed or missed PDUFA dates for Stealth Therapeutics’ rare disease candidate, KalVista Pharmaceuticals' angioedema asset and Omeros’ transplant drug, despite Commissioner Marty Makary, M.D.’s, June pledge that the agency would meet all of its deadlines.