The FDA cleared Amygdala Neurosciences’ Investigational New Drug application for ANS-858, allowing the company to move the drug into clinical development.
ANS-858 is a selective, reversible, orally bioavailable inhibitor of aldehyde dehydrogenase 2 (ALDH2), according to an Aug. 18 news release from the company. It plans to begin a phase 1 clinical trial, which is designed to support later evaluation of ANS-858 across multiple indications in phase 2 clinical trials.
Amygdala Neurosciences is initially advancing ANS-858 as a potential treatment for alcohol use disorder and other substance use disorders. It is also evaluating the drug in compulsive eating disorders associated with binge eating and obesity.
The company is separately evaluating its selective ALDH2 inhibitors in precision oncology, including as a potential therapeutic approach for colorectal cancers harboring adenomatous polyposis coli (APC) mutations. Amygdala Neurosciences estimates that APC mutations are present in approximately 70% of colorectal cancer cases.
ANS-858 remains investigational and has not been approved by the FDA or any other regulatory authority.
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