Allyx Therapeutics Begins Treating Alzheimer's Patient with ALX-001

June 11, 2024 – Allyx Therapeutics, a biotechnology firm focused on innovative treatments for neurodegenerative diseases, has announced the commencement of a clinical study involving its leading compound, ALX-001. The first Alzheimer's disease patient has been administered ALX-001, marking a significant milestone in the drug's clinical journey. ALX-001 is a pioneering synapse-targeted oral therapy that is set to enter Phase 2 of clinical development.

Stephen Bloch, M.D., CEO and co-founder of Allyx Therapeutics, expressed enthusiasm about this development, highlighting the importance of this phase in the advancement of ALX-001. Bloch noted the potential of ALX-001 to become a groundbreaking disease-modifying molecule for neurodegenerative conditions.

The ongoing study is enlisting Alzheimer’s patients aged 50 to 80 for a 28-day trial period. Participants will receive ALX-001 in doses of either 50 mg or 100 mg, administered twice daily, or a placebo. This phase follows an earlier stage that evaluated multiple ascending doses in healthy individuals (NCT05804383) and is being conducted at Yale School of Medicine with backing from the National Institute on Aging.

Stephen Strittmatter, M.D., Ph.D., the scientific founder of Allyx Therapeutics and professor at Yale School of Medicine, underscored the significance of this stage in the clinical evaluation of ALX-001. Strittmatter emphasized the drug’s unique mechanism of action and early positive data, which have fueled hopes for its potential impact on Alzheimer's disease.

With over twelve years of clinical research, ALX-001 has demonstrated encouraging results and is supported by prestigious third-party organizations. The program has secured more than $20 million in grants from the National Institutes of Health, the U.S. Government’s Small Business Innovation Research (SBIR) programs, the Alzheimer’s Association, and The Michael J. Fox Foundation for Parkinson’s Research, among others.

About ALX-001

ALX-001, previously known as BMS-984923, is a silent allosteric modulator of mGluR5. This first-in-class compound selectively inhibits the harmful activation of the receptor, preserving normal glutamate signaling essential for cognitive functions. This unique mechanism provides a broad therapeutic window, avoiding the toxic effects associated with negative allosteric modulators. mGluR5 is crucial in mediating synaptic dysfunction and loss due to various misfolded extracellular proteins, offering a novel treatment approach for Alzheimer's and Parkinson's diseases. ALX-001 is an orally bioavailable small molecule that effectively penetrates the brain and engages mGluR5 selectively. Initially identified by Bristol Myers Squibb, its potential as a disease-modifying treatment for Alzheimer's was discovered by Stephen Strittmatter at Yale School of Medicine. Allyx Therapeutics holds an exclusive worldwide license for ALX-001 from Bristol Myers Squibb and Yale School of Medicine.

About Allyx Therapeutics

Founded in 2019, Allyx Therapeutics comprises experienced biopharma professionals, venture capitalists, and scientific experts. The company is dedicated to developing novel therapies to protect synapses in patients with neurodegenerative diseases. The primary focus is on ALX-001, a first-in-class oral therapy with a distinctive mGluR5 mechanism, now in clinical trials for Alzheimer’s and Parkinson’s diseases.

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