ALX-001 safety strengthened by new data presented at the following conference AD/PD™ 2024 Conference in Lisbon
Two oral doses selected for further study in Alzheimer’s and Parkinson’s disease patients
NEW HAVEN, Conn., March 11, 2024 (Globe Newswire) — Allyx Therapeutics, a clinical-stage biotechnology company, prepares lead compound ALX-001 to advance to Phase 2 clinical development for Alzheimer’s and Parkinson’s diseases. announced that it has been completed. . This announcement was made in conjunction with the presentation of positive results from the company’s Phase 1b multiple escalating dose study at the AD/PD™ 2024 conference in Lisbon. ALX-001 is a highly selective, first-in-class, synapse-targeted, disease-modifying oral therapy being developed for neurodegenerative diseases.
A multiple escalating dose study (NCT05804383) investigated the safety, tolerability, and pharmacokinetics of ALX-001 administered orally twice daily in 32 healthy adult participants aged 50 to 80 years. I looked into it. Study results show that ALX-001 is safe in cognitively normal older adults at all doses tested. ALX-001 successfully achieved high exposure and characterized a wide safety range at all doses ranging from 50 mg to 150 mg. Her two doses of 50mg and 100mg were identified for future studies. All doses were well tolerated with no serious adverse events.
“The data show that ALX-001 achieved high target engagement without mGluR5-related adverse events. It supports our vision of mediating dysfunction and loss,” commented Stephen Strittmatter, MD. Ph.D., scientific founder of Allyx Therapeutics and professor and professor of neuroscience at Yale University School of Medicine.
Built on 12 years of clinical research, ALX-001 continues to show promise in ongoing studies. Allyx Therapeutics has begun its 28-day safety study (NCT05804383) of its ALX-001 in Alzheimer’s disease patients and is also starting a study in Parkinson’s disease patients.
“We are excited to begin the next phase of development by initiating two 28-day patient studies, the first studies of ALX-001 in people with Alzheimer’s and Parkinson’s disease. ” commented Dr. Tim Siegert, Director of Operations. Director and co-founder of Alix Therapeutics. “The results of the Phase 1b MAD study directly support large-scale Phase 2 clinical development to more fully understand the potential of ALX-001 to become the first-ever disease-modifying small molecule for neurodegenerative diseases. believe.”
The ALX-001 program received more than $20 million in grants from the National Institutes of Health, the U.S. government’s Competitive Small Business Innovation Research (SBIR) program, the Alzheimer’s Association, and the Michael J. Fox Foundation for Parkinson’s Disease Research. I am. Among other things. In addition to the continued clinical development of ALX-001 in Alzheimer’s disease, Alix announced its expansion into clinical research in Parkinson’s disease with the initiation of an investigational new drug application with the U.S. Food and Drug Administration (FDA).
About ALX-001
ALX-001 (formerly BMS-984923) is a silent allosteric modulator of mGluR5 that selectively blocks pathogenic activation of the receptor while preserving normal physiological glutamate signaling required for cognition. It is an in-class compound. Thus, ALX-001 has a broad therapeutic range that can saturate the receptor while avoiding on-target toxicity observed with negative allosteric modulators. mGluR5 has been shown to be essential in mediating synaptic dysfunction and loss caused by multiple misfolded extracellular protein species, providing a new approach to treating Alzheimer’s and Parkinson’s diseases. Importantly, ALX-001 is an orally bioavailable and brain-penetrating small molecule with demonstrated selective engagement of mGluR5. Although this molecule was originally identified by Bristol-Myers Squibb, his identification of ALX-001 as a mechanism of action against neurodegenerative diseases and as a disease-modifying agent against Alzheimer’s disease was influenced by the founder of Alyx Science, Yale University. Discovered by Steven Strittmatter. Allyx Therapeutics has acquired an exclusive worldwide license for ALX-001 from Bristol Myers Squibb and Yale University.
About Alix Therapeutics
Allyx Therapeutics was founded in 2019 by a group of seasoned biopharmaceutical industry executives, venture capitalists, and scientific experts. The company aims to offer a new approach to preserving and protecting synapses for people living with neurodegenerative diseases. Its lead compound, his ALX-001, is a first-in-class oral therapy in clinical development for Alzheimer’s and Parkinson’s diseases with a unique mechanism of action at mGluR5. For more information, please visit allyxthera.com.
contact
Media: Eliza Schleifstein
917.763.8106
Eliza@schleifsteinpr.com
Investor: Tim Siegert
203-691-6543
tsiegert@allyxthera.com
