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December 21, 2023

Allyx Therapeutics Lead Compound ALX-001 is Safe and Tolerable at Doses, Achieving Full Brain Target Engagement in Healthy Older Adults

NEW HAVEN, Conn., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Allyx Therapeutics, a clinical-stage biotechnology company which is developing ALX-001, a highly selective, first-in-class, synapse-targeted, disease-modifying oral therapy for neurodegenerative diseases, presented Phase 1a single ascending dose study results at the 16th Clinical Trials on Alzheimer's Disease (CTAD) meeting in Boston on October 27, 2023. The study showed that all doses of ALX-001 were well tolerated, up to and including levels high enough to achieve full brain target engagement, supporting the company’s plans to continue clinical development for the treatment of Alzheimer’s disease.

This phase 1a open-label study evaluated the safety, tolerability, pharmacokinetics, and brain receptor occupancy of increasing doses of orally-administered ALX-001. Single ascending doses were administered in 36 healthy adults between 50 and 80 years old with normal cognition. Safety findings were also encouraging. All doses of ALX-001 were well-tolerated and there were no serious adverse events. The data were presented by principal investigator Adam Mecca, M.D., Ph.D. of the Yale School of Medicine Alzheimer’s Disease Research Unit. The study was conducted at Yale and supported with grant funding from the National Institutes of Health and the Alzheimer’s Association.

“The unique mechanism of action of ALX-001 at mGluR5 holds great promise as a novel approach to preserve and protect synapses for people living with neurodegenerative diseases,” commented Tim Siegert, Ph.D., chief operating officer and co-founder of Allyx Therapeutics. “We are thrilled to observe the clinical community’s response to our initial clinical data as we work to deliver a first-in-class oral therapy for people living with Alzheimer’s disease.”

ALX-001 continues to demonstrate promise in ongoing studies that build on twelve years of research. Clinical research of ALX-001 in Alzheimer’s disease is advancing, with a Phase 1 multiple ascending dose study in healthy volunteers expected to finish in Q4 2023.

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