Allyx Therapeutics announced that it has been awarded a $3.3 million grant from the National Institutes of Health as part of its Small Business Innovation Research Commercial Readiness Pilot program. This funding round will support further investigation of Allyx’s lead clinical asset, ALX-001 (a highly-selective, first-in-class, synapse-targeted, disease-modifying oral therapy in development for the treatment of Alzheimer’s disease and Parkinson’s disease).
Allyx plans to utilize the Commercial Readiness Pilot funding to support a Phase I clinical pharmacokinetic drug-drug interaction study (NCT06632990) to determine the impact of multiple doses of ALX-001 on various cytochrome P450 enzymes. And the first doses of ALX-001 were recently administered to people living with Alzheimer’s disease and Parkinson’s disease as part of two Phase Ib clinical studies (NCT05804383 and NCT06309147) currently underway in these patient populations. ALX-001 is ready to proceed to Phase 2 clinical development and is not restricted by completion of ongoing or planned studies.
With this grant, the ALX-001 program has been awarded more than $23 million in funding following previous grants from the National Institutes of Health, the U.S. Government’s highly competitive Small Business Innovation Research (SBIR) program, the Alzheimer’s Association and The Michael J. Fox Foundation for Parkinson’s Research, among others.
KEY QUOTES:
“We are honored to receive this grant from the National Institutes of Health Small Business Innovation Research Program as we continue to advance toward commercialization of ALX-001 as a potential first-in-class disease-modifying oral therapy in Alzheimer’s disease and Parkinson’s disease. The metabolism study funded by this grant will help us to better understand the metabolic profile of ALX-001 which will be important for patient populations with a high likelihood of complex polypharmacy and comorbidities beyond neurodegenerative diseases.”
-Tim Siegert, Co-Founder and COO at Allyx Therapeutics
