Allyx Therapeutics Announces License For The Treatment of Cognitive Deficits in Neurodegenerative Disorders From Bristol Myers Squibb And Yale

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Today, Allyx Therapeutics announced the completion of a license agreement with Bristol Myers Squibb to develop Allyx’s novel therapy for Alzheimer’s disease. The agreement includes a sublicense of certain rights from Yale University. To protect vulnerable neurons and preserve cognition in Alzheimer’s patients, Allyx expects to advance ALX-001, a small-molecule modulator of metabotropic glutamate receptor 5 (mGluR5), licensed from Bristol Myers Squibb, into clinical trials in 2021.

Alzheimer’s disease is a devastating illness with more than 5.6 million patients in the United States alone, lacking any disease-modifying therapy. Innovative therapeutic approaches are desperately needed as previous attempts aimed at removing amyloid-beta plaques and more recently removing tau protein have failed to show efficacy. Novel strategies are required that address the underlying biology of the disease beyond plaque or tangle accumulation.

In the brain, synapses transmit signals between neurons and enable cognition. Recent clinical evidence highlights synapse loss as a main driver of Alzheimer’s disease progression. Robust scientific evidence establishes that targeting mGluR5 may provide beneficial effects. In a pivotal discovery published in Cell Reports by Allyx Co-Founder and Yale School of Medicine Professor Stephen Strittmatter, a mGluR5 modulator reversed disease course in animal models of Alzheimer’s disease. Dr. Strittmatter said, “Our preclinical testing of optimal mGluR5-directed compounds licensed from Bristol Myers Squibb demonstrated robust efficacy and safety profile. A lead compound from this portfolio, now named ALX-001, is expected to enter human clinical trials in early 2021.” ALX-001 is an orally bioavailable small molecule with excellent drug properties including selectivity and brain penetration. In addition, clinical development is enabled by multiple brain imaging tools to establish brain exposure in humans and track its ability to preserve, or reverse, synapse loss in patients.

“The unmet medical need for a safe and effective treatment for Alzheimer’s disease is enormous, and the mGluR5 modulator licensed from Bristol Myers Squibb shows great promise in that respect,” said Dr. John Puziss, Executive Director of Business Development at the Yale Office of Cooperative Research. “We are grateful for the participation of the Allyx team to advance this important potential drug toward the clinic.”

“Protecting the synapse is a compelling treatment rationale for a ravaging disease,” said Stephen Bloch, MD, CEO of Allyx Therapeutics. “We look forward to advancing ALX-001 in clinical trials as soon as the beginning of 2021.”

Forward-Looking Statements:
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition.

About Allyx Therapeutics:
Founded in 2019, Allyx Therapeutics is a clinical-stage biotechnology company based in New Haven, CT, developing new therapies to protect synapses from destruction in Alzheimer’s disease and other related neurodegenerative diseases. Allyx Therapeutics is launched with an mGluR5 modulator lead asset, ALX-001, with expected clinical initiation in early 2021. More information is available at https://www.allyxthera.com.

About the Yale Office of Cooperative Research:
Since its founding in 1982, the Yale Office of Cooperative Research (OCR) has built a significant portfolio of inventions and patents and has grown into an engine of regional economic development. Its mission is to facilitate the translation of research from Yale’s labs into products and services that benefit society. OCR is recognized as a leading force for catalyzing economic growth by identifying, counseling and nurturing early-stage technologies and guiding the transition into robust companies. More information is available at https://ocr.yale.edu/.

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