Psyence Biomed Announces Worldwide Exclusive Licensing Agreement with PsyLabs to Supply Nature-Derived Psilocybin to be Evaluated as a Potential Treatment for Alcohol Use Disorder (AUD) and Other Substance Use Disorders (SUDs)

Psyence Biomed to focus on AUD, its second development indication

NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM, PBMWW) (“Psyence Biomed” or the “Company”) today announced that the Company has entered into a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs, a private company focused on the production of psychedelic active pharmaceutical ingredients and extracts. Pursuant to this licensing agreement, PsyLabs will supply Psyence Biomed with pharmaceutical-grade, EU GMP nature-derived (non-synthetic) psilocybin to be evaluated in future clinical trials as a potential treatment for AUD and other SUDs, and for commercialization of the licensed product. Psyence Biomed plans to lead with a clinical trial in AUD, Psyence Biomed’s second development indication. The licensed product will require further development work by PsyLabs, which will be conducted during the remainder of 2024 and into 2025.

Development of Psyence Biomed’s first indication is planned to commence with a Phase IIb trial to evaluate nature-derived psilocybin in Adjustment Disorder in patients who have had an advanced cancer diagnosis in the Palliative Care context.

In 2021 in the U.S., 44.4 million people aged 18 or older had a substance or alcohol use disorder, including 21.8 million who had an alcohol use disorder (AUD), 15.6 million who had a drug use disorder (DUD), and 7.0 million people who had both an AUD and a DUD¹. Existing treatments include behavioral therapies, mutual-support groups, and/or medications.

“Alcohol and substance use disorders represent significant burdens to society, and prior academic studies^2,3,4 have shown that psilocybin, when combined with psychotherapy, can be a safe and effective treatment option for the millions of people suffering from AUD and other SUDs for whom current treatment options are of limited benefit,” stated Neil Maresky, MD, Chief Executive Officer of Psyence Biomed. “As we pursue our next indications, this new agreement with PsyLabs demonstrates our commitment to advance the highest quality psilocybin candidate into clinical development.”

“At PsyLabs, we have worked tirelessly to develop extraction and production capabilities that we believe will result in the purest pharmaceutical grade nature-derived psilocybin available to psychedelic drug developers worldwide,” stated Tony Budden, Chief Executive Officer of PsyLabs. “We are very pleased to enter into this exclusive agreement with Psyence Biomed and look forward to playing a key role in the potential introduction of a novel treatment paradigm for AUD and other SUDs, significant patient populations with urgent unmet needs.”