NEW HAVEN, Conn., Oct. 15, 2024 (GLOBE NEWSWIRE) — Allyx Therapeutics announced today 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 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 intends 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. 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.
“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,” stated Tim Siegert, Co-Founder and COO at Allyx Therapeutics. “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.”
With this latest 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.
About ALX-001
ALX-001 (previously BMS-984923) is a silent allosteric modulator of mGluR5, and is a first-in-class compound that selectively blocks the pathogenic activation of the receptor while preserving the normal physiological glutamate signaling that is required for cognition. As such, ALX-001 has a wide therapeutic window that can saturate receptors while avoiding on-target toxicity observed with negative allosteric modulators. mGluR5 has been shown to be essential for mediating synaptic dysfunction and loss caused by multiple misfolded extracellular protein species, and as such, presents a novel approach for treating Alzheimer’s and Parkinson’s disease. Importantly, ALX-001 is an orally bioavailable and brain penetrant small molecule with demonstrated mGluR5 selective engagement. The molecule was originally identified by Bristol Myers Squibb, but the mechanism of action for neurodegenerative diseases and the identification of ALX-001 as disease-modifying for Alzheimer’s disease was discovered by Allyx scientific founder Stephen Strittmatter at Yale School of Medicine. Allyx Therapeutics obtained an exclusive worldwide license for ALX-001 from Bristol Myers Squibb and Yale School of Medicine.
About Allyx Therapeutics
Allyx Therapeutics was founded in 2019 by a group of seasoned biopharma industry executives, venture capitalists, and scientific experts. The company aims to deliver a novel approach to preserve and protect synapses for people living with neurodegenerative diseases. Its lead compound, ALX-001, is a first-in-class oral therapy with a unique mechanism of action at mGluR5 in clinical development for Alzheimer’s disease and Parkinson’s disease. Learn more at allyxthera.com.
