Psyence Biomed Secures Global Deal with PsyLabs for Natural Psilocybin to Treat AUD and SUDs

Psyence Biomedical Ltd. (Nasdaq: PBM, PBMWW) announced a global, exclusive licensing agreement with PsyLabs. The agreement grants Psyence Biomed access to pharmaceutical-grade, EU GMP nature-derived psilocybin provided by PsyLabs. This psilocybin will be assessed in upcoming clinical trials as a potential treatment for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs), with plans for commercialization.

Psyence Biomed will initiate its trials focusing on AUD, marking its second development indication. PsyLabs will continue to develop the licensed product through the remainder of 2024 into 2025. Psyence Biomed is also preparing for a Phase IIb trial to evaluate the use of nature-derived psilocybin for Adjustment Disorder in palliative care patients diagnosed with advanced cancer.

In 2021, 44.4 million U.S. adults suffered from substance or alcohol use disorders. This included 21.8 million with AUD, 15.6 million with Drug Use Disorder (DUD), and 7.0 million with both AUD and DUD. Current treatments encompass behavioral therapies, support groups, and medications. 

"Alcohol and substance use disorders are significant societal burdens," said Neil Maresky, MD, CEO of Psyence Biomed. "Studies have shown that psilocybin, when combined with psychotherapy, can be a safe and effective treatment for people who do not benefit from existing treatments."

Tony Budden, CEO of PsyLabs, added, "We have developed extraction and production processes to create the purest pharmaceutical-grade psilocybin. This agreement with Psyence Biomed is a crucial step in introducing novel treatments for AUD and other SUDs, which affect large patient populations with unmet needs."

PsyLabs, a federally licensed psychedelic Active Pharmaceutical Ingredient (API) development company, cultivates and exports psilocybin mushrooms and other compounds like psilocin, mescaline, ibogaine, and DMT. The company has demonstrated the ability to purify natural psilocybin to unprecedented levels using proprietary technologies. PsyLabs is currently scaling up to full commercial production and formulation, collaborating with a major UK contract manufacturing organization.

Psyence Biomedical Ltd. is noted for being the first biotechnology company focused on developing nature-derived psilocybin-based psychedelic medicine listed on Nasdaq. The company's name, "Psyence," reflects its commitment to science-based innovation in creating psychedelic therapeutics for various mental health disorders, with an initial focus on palliative care contexts.

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