The US Food and Drug Administration (FDA) has cleared Amygdala Neurosciences’ Investigational New Drug (IND) application for ANS-858, enabling the company to advance its lead candidate into clinical development.
ANS-858 is a selective, reversible, orally bioavailable inhibitor of ALDH2. The company is initially developing the drug as a potential treatment for alcohol use disorder and other substance use disorders.
By selectively and reversibly inhibiting ALDH2, Amygdala believes the investigational drug has the potential to reduce pathological craving, a major driver of substance use and relapse.
The company plans to initiate a Phase 1 clinical trial of ANS-858, with the goal of generating data to support subsequent Phase 2 studies across multiple indications.
“FDA clearance of our IND for ANS-858 represents an important milestone for Amygdala Neurosciences and our first-in-class ALDH2 therapeutic platform,” said Brent Blackburn, CEO, Amygdala Neurosciences.
“Our research has demonstrated the important role of ALDH2 in pathological craving and led to the development of selective inhibitors designed to translate this biology into novel therapeutic approaches. Importantly, the therapeutic rationale for ALDH2 inhibition is supported by both human genetic and clinical evidence linking reduced ALDH2 activity with reduced alcohol consumption. With clearance of the IND, we look forward to advancing ANS-858 into clinical development and building upon this evidence,” he added.
The company is also evaluating ANS-858 for compulsive eating disorders associated with binge eating and obesity. Based on similarities between the biological mechanisms underlying pathological food and substance craving, Amygdala believes ANS-858 could potentially be developed as a once-daily oral therapy for reducing food cravings and supporting long-term weight management, either as a standalone therapy or as an adjunct to GLP-1 receptor agonists.
Separately, the company is investigating its proprietary library of selective ALDH2 inhibitors in precision oncology, including as a potential treatment approach for colorectal cancers carrying APC mutations. APC is a tumour-suppressor gene involved in colorectal cancer biology, and the company estimates that APC mutations occur in approximately 70% of colorectal cancer cases.
Amygdala Neurosciences is a US-based, clinical-stage biopharmaceutical company developing selective ALDH2 inhibitors for multiple therapeutic applications. Its platform is protected by composition-of-matter intellectual property and is designed to generate potential treatments targeting ALDH2 as a regulator of pathological craving and disease biology.
