Psychedelic drug treatment companies are racing to find a cure for alcohol use disorder or alcoholism. This week, atai Life Sciences gave investors an update on its DMT-based drug, while Awakn Life Sciences updated the market on its ketamine-based drug for the same disorder.

The World Health Organization estimates that around 400 million people suffer from AUD worldwide, with around 3 million deaths each year attributed to alcoholism. With such a large patient population, a solution would be a financial home run for these companies – not to mention the benefits to the patients.

Atai’s update

Atai Life Sciences (NASDAQ: ATAI) announced positive topline results from Beckley Psytech’s Phase 2a open-label study of BPL-003 in 12 patients with moderate to severe AUD. The company told investors that a single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months. Atai said it expects to have the Phase 2b data readout of BPL-003 midyear.

“We are encouraged by these exploratory results from Beckley Psytech, our strategic investment, which demonstrate the potential of short in-clinic psychedelic therapies to transform the treatment of substance use disorders,” said Dr. Srinivas Rao, CEO and co-founder of atai. “The high rates of sustained abstinence in this study are particularly promising given the significant challenges patients with alcohol use disorder face in achieving and maintaining abstinence. These findings add to the growing body of evidence supporting the potential of BPL-003 in treating serious mental health disorders.”

Atai’s BPL-003 is a patent-protected synthetic intranasal formulation of 5-MeO-DMT benzoate which is designed to deliver rapid and durable treatment effects from a single dose with a short in-clinic treatment time.

Awakn’s update

Awakn Life Sciences Corp. (CSE: AWKN) (OTC Pink: AWKNF) has two drugs to treat AUD, designated as AWKN-001 and AWKN-002, and both use a ketamine base. AWKN-001 is in Phase 3 in the U.K. The company told investors it is targeting a Regulation 52b hybrid application in the U.K. for AWKN-001.

“If successful, this could provide 8 years of market exclusivity, with an additional 2 years of supplementary protection, preventing competitors from marketing a similar product for the same indication,” the company said in a statement.

Concerning AWKN-002, the company said it completed a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration, which confirmed that AWKN-002 can be reviewed under the 505(b)(2) NDA pathway. The FDA also further confirmed that no additional clinical data are needed to proceed with a Phase 2b trial in patients with moderate to severe AUD.

Awakn said in a statement that it plans to submit an IND Application for AWKN-002 in the second half of 2025, followed by a Clinical Trial Application for a Phase 2b trial in the first half of 2026. If all goes well, the company will have market exclusivity for five years.

“We are excited about the progress across our key R&D programs, particularly in the areas of Alcohol Use Disorder and PTSD. With the advancements we’ve made in AWKN-001 and AWKN-002, we’re on track to deliver transformative therapies for patients in need of more effective solutions,” Anthony Tennyson, CEO of Awakn said.

Green Market Report wrote in December that Awakn would be bought by Graft Polymer (UK) PLC with Graft acquiring all of the company’s shares in a deal valued at C$8.8 million. That deal is expected to close in the summer of 2025.

The Daily Hit is a recap of the top financial news stories for Monday, December 16, 2024.

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