atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced that it has been awarded a grant of up to $11.4 million from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to advance its work on novel therapies for opioid use disorder (OUD).
The company said the five-year UG3/UH3 grant will support optimization and early-stage development of atai’s 5-HT2A/2C receptor agonists, which are designed to retain therapeutic activity without hallucinogenic effects.
The funding will cover lead optimization, proof-of-concept studies, toxicology, and manufacturing needed to file an Investigational New Drug application.
If successful, the program could move into a first-in-human Phase 1 trial.
atai said the goal is to identify clinical candidates that act on serotonin receptors associated with addiction while avoiding mechanisms linked to safety risks such as cardiac valvulopathy.
“The commitment of Federal support to advance innovative and differentiated research in OUD highlights the devastating toll this crisis continues to take on individuals, families, and communities,” atai CEO Dr Srinivas Rao said in a statement.
“This investment demonstrates the urgent need for evidence-based prevention, treatment, and long-term recovery solutions that can truly make a difference.”
Dr Glenn Short, atai chief scientific officer, added that this is the first external validation of atai’s AI-driven polypharmacology drug discovery approach and its 5-HT2A/2C agonist program.
“This recognition helps to establish atai as a leader in the non-hallucinogenic 5-HT2A agonist drug space and accelerates the timetable to bring these innovative treatments to patients suffering from addiction,” Short said.
OUD affects an estimated 16 million people worldwide, with economic costs exceeding $750 billion annually and more than 120,000 opioid-related deaths reported each year, according to public health data.