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March 11, 2024

FDA OKs clinical research application for new Parkinson’s drug from New Haven-based Allyx Therapeutics

Contributed Dr. Stephen Bloch, co-founder and CEO of Allyx Therapeutics Inc.
By David Krechevsky

The U.S. Food and Drug Administration earlier this month approved an application from a New Haven-based biotechnology company to conduct clinical research on a new treatment for Parkinson’s disease.

Allyx Therapeutics Inc., which is headquartered at 555 Long Wharf Drive in New Haven, said the FDA accepted its Investigational New Drug Application (IND) for ALX-001, an oral therapy for diseases that cause degeneration of the body’s nervous system. ALX-001 is a first-in-class, synapse-targeted therapy, the company said.

With the FDA’s approval, Allyx will conduct a 28-day safety study on Parkinson’s patients during the first quarter of this year.

Dr. Stephen Bloch, co-founder and CEO of Allyx, said his company is “working with urgency” to understand how ALX-001 “can introduce meaningful clinical benefits for people living with Alzheimer’s disease and Parkinson’s disease. Our aim is to deliver the first-ever disease-modifying small molecule for these and other neurodegenerative diseases.”

The ALX-001 program has received more than $20 million in grant funding from the National Institutes of Health (NIH), U.S. Small Business Innovation Research (SBIR) programs and The Michael J. Fox Foundation for Parkinson’s Research, among others. 

As studies in Parkinson’s disease begin, Allyx said, it will continue to advance clinical development of ALX-001 in Alzheimer’s disease, which is funded through grants from the NIH and other Alzheimer’s disease research nonprofit organizations

“The generous grant from The Michael J. Fox Foundation for Parkinson’s Research contributes to research efforts around the potential of ALX-001, enabling our work to move into clinical research without delay,” said Tim Siegert, chief operating officer and co-founder of Allyx Therapeutics. “We have the talent and the capital needed to rapidly advance our clinical development program and progress toward transforming the future for people living with serious and debilitating neurodegenerative diseases.”

Allyx Therapeutics was founded in 2019 by a group of biopharma industry executives, venture capitalists, and scientific experts.

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