Amygdala Neurosciences Announces FDA Clearance of IND for ANS-858, a First-in-Class ALDH2 Inhibitor
核心洞察
Amygdala Neurosciences (搜索) received FDA clearance of its Investigational New Drug (IND) application for ANS-858, enabling advancement into clinical development.
ANS-858 is a selective, reversible, orally bioavailable, once-daily ALDH2 (搜索) inhibitor being developed initially for alcohol use disorder (搜索) and other substance use disorders (搜索).
The company plans to initiate a Phase 1 trial to support subsequent Phase 2 evaluation across multiple indications, including binge eating (搜索), obesity (搜索), and precision oncology.
Amygdala Neurosciences (搜索), Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for ANS-858, enabling the Company to advance its lead clinical candidate into clinical development. ANS-858 is a selective, reversible, orally bioavailable inhibitor of ALDH2 (搜索), and the Company plans to initiate a Phase 1 clinical trial designed to support the subsequent evaluation of ANS-858 across multiple indications in Phase 2 clinical trials.
"FDA clearance of our IND for ANS-858 represents an important milestone for Amygdala Neurosciences (搜索) and our first-in-class ALDH2 (搜索) therapeutic platform," said Brent Blackburn, Ph.D., Chief Executive Officer of 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."
A First-in-Class ALDH2 Inhibitor Platform
Amygdala Neurosciences (搜索) has developed what it believes are the first and only known selective, orally bioavailable, once-daily inhibitors of ALDH2 (搜索). The Company's first-in-class platform is protected by composition-of-matter intellectual property and is designed to provide multiple potential therapeutic opportunities by targeting ALDH2, which Amygdala has identified as an important regulator of pathological craving and disease biology.
ANS-858 is initially being advanced as a potential treatment for alcohol use disorder (搜索) and other substance use disorders (搜索). By selectively and reversibly inhibiting ALDH2 (搜索), Amygdala believes ANS-858 has the potential to reduce pathological craving, a major driver of substance use and relapse. Clinical proof of concept with ANS-858 would build upon existing human genetic and clinical evidence supporting ALDH2 inhibition and provide important validation of the Company's proprietary ALDH2 therapeutic platform.
Expanding Indications in Metabolic and Oncology Settings
The Company is also evaluating ANS-858 in compulsive eating disorders associated with binge eating (搜索) and obesity (搜索), based on similarities between the biological mechanisms underlying pathological food craving and those involved in substance use disorders (搜索). ANS-858 has the potential to be developed as a once-daily oral therapy to reduce pathological food cravings and support long-term weight management, either as a standalone therapy or as an adjunct to GLP-1 receptor agonists (搜索).
Separately, Amygdala Neurosciences (搜索) is evaluating its proprietary library of selective ALDH2 (搜索) inhibitors in precision oncology, including as a potential therapeutic approach for colorectal cancers harboring APC (搜索) mutations. APC is a tumor-suppressor gene that plays a central role in colorectal cancer (搜索) biology. The Company estimates that APC mutations are present in approximately 70% of colorectal cancer cases, representing a large genetically defined patient population for evaluation of an ALDH2-targeted therapeutic approach.
Funding and Company Background
The discovery and development of ANS-858 have been supported, in part, by NIH grants R43AA029311 and U43AA030689 and by investment support from ABMRF/The Foundation for Alcohol Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Amygdala Neurosciences (搜索), Inc. is a clinical-stage biotechnology company developing a proprietary platform of first-in-class, selective ALDH2 (搜索) inhibitors for multiple therapeutic applications. The Company is led by an experienced team of scientist-entrepreneurs with a track record of developing and commercializing novel therapeutics, including Ranexa® and Lexiscan®. CEO Brent Blackburn, Ph.D., previously led Research and Development at CV Therapeutics and founded Rapiscan Pharma Solutions, which was acquired by GE Healthcare.
ANS-858 is investigational and has not been approved by the FDA or any other regulatory authority.