NEW YORK, Oct. 17, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) is pleased to provide an update on its previously-announced pending strategic acquisition of an equity stake in PsyLabs, and progress with PsyLabs’ collaboration with its contract drug manufacturing organization (CDMO). This collaboration is key to advancing the development of PsyLabs’ nature-derived psychedelic active pharmaceutical ingredients (APIs) towards E.U. Good Manufacturing Practices (GMP) certification.
In September 2024, Psyence Biomed entered into a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs for pharmaceutical-grade, EU GMP certified, nature-derived psilocybin to be evaluated in future clinical trials as a potential treatment for Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs), and for commercial supply, if approved.
Following the successful export of its psilocybin extract to its CDMO in the UK, PsyLabs has now entered phase two of its development process. The CDMO has commenced work on upscaling the purification process to validate its commercial viability, ensuring that the extraction methodology developed by PsyLabs can be efficiently scaled for larger production volumes. This critical phase will confirm that the methods used to achieve PsyLabs’ high-purity psilocybin can be replicated on a commercial scale, setting the foundation for E.U. GMP certification.
Strategic Progress Toward Commercial Viability
This milestone represents significant progress in PsyLabs’ journey to produce E.U. GMP certified APIs. The ability to scale the extraction process while maintaining high purity levels is essential for meeting the rigorous demands of global health regulators and advancing through Phase III clinical trials. PsyLabs’ collaboration with its CDMO is designed to ensure that PsyLabs’ APIs are commercially viable and meet the highest quality standards, providing a faster route to market for psychedelic-based therapies.
Enhancing Psyence Biomed’s Investment Value
Psyence Biomed’s pending acquisition of an equity stake in PsyLabs continues to align with its strategy of securing access to pharmaceutical-grade, naturally derived APIs that can serve as the foundation for future clinical trials and FDA-approved drug development. This update marks another important step in solidifying a consistent supply of high-purity psilocybin.
As this next phase progresses, Psyence Biomed remains confident that PsyLabs is on track to produce GMP certified, nature-derived psychedelic APIs. These developments underscore Psyence Biomed’s commitment to innovation and leadership in the psychedelic sector. PsyLabs’ proprietary methods, combined with strategic collaborations like the one with its CDMO, will continue to provide Psyence Biomed with a competitive edge in bringing next-generation mental health treatments to market.
“Our strategic acquisition of an equity stake in PsyLabs, when completed later this year, will transition Psyence Biomed into a fully vertically integrated developer of psilocybin-based therapeutics that address significant unmet needs in mental health and addiction,” said Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed. “PsyLabs’ continued progress toward the production of E.U. GMP certified APIs is a critical step going forward, and we are very pleased with their progress to date. We look forward to a long and mutually beneficial partnership with PsyLabs as we advance a psilocybin-based therapeutic as a potential treatment for AUD.”
Tony Budden, Chief Executive Officer of PsyLabs, said “We believe our proprietary extraction process will create the highest purity psilocybin available on the market, at a time when regulatory agencies around the world are placing greater emphasis on purity in psychedelic-based drug development programs.
Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the world’s few biopharmas with a focus on psychedelic-based pharmaceutical therapeutics. As the first life science biotechnology company developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq, Psyence is initially working to address the unmet needs of patients who suffer from mental health disorders in the context of Palliative Care. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, FDA-approved, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Learn more at www.psyencebiomed.com and on LinkedIn.