Psyence Biomedical provides update on PsyLabs E.U. GMP certified API development

Psyence Biomedical provided 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. This collaboration is key to advancing the development of PsyLabs’ nature-derived psychedelic active pharmaceutical ingredients towards E.U. Good Manufacturing Practices 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 and other Substance Use Disorders, 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. 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. 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.