Psyence Biomedical Ltd. (Nasdaq: PBM) has entered into binding agreements with Optimi Health Corp. to secure an exclusive supply of GMP-certified, nature-derived psilocybin for its clinical research and drug development programs in palliative care. This collaboration supports Psyence Biomed's ongoing Phase IIb clinical trial for Adjustment Disorder and sets the stage for future Phase III studies and potential commercialization.
Exclusive Supply Agreement
Under the terms of the agreement, Optimi Health will be the sole provider of GMP-certified psilocybin for Psyence Biomed's global palliative care programs. This exclusivity ensures a consistent and reliable supply of high-quality psilocybin, a critical factor in clinical trials and drug development.
"This partnership highlights Optimi's leadership in the production of high-quality psilocybin drug candidates for clinical trials," said Dane Stevens, Chief Executive Officer of Optimi. "As Psyence Biomed's exclusive supplier, we are proud to support their important work addressing significant unmet mental health needs in Palliative Care."
Phase IIb Clinical Trial for Adjustment Disorder
Psyence Biomed's Phase IIb clinical trial is currently evaluating psilocybin for the treatment of Adjustment Disorder in palliative care patients. This trial addresses a significant unmet need, as many individuals undergoing palliative care experience mental health challenges that can impact their quality of life. The trial is being conducted in Australia through Psyence Biomed's Australian subsidiary, Psyence Australia Pty Ltd.
CMC and IND Support
Optimi Health will provide comprehensive Chemistry, Manufacturing, and Control (CMC) support to facilitate Psyence Biomed's regulatory submissions, including Investigational New Drug (IND) applications with the U.S. Food and Drug Administration (FDA). This support is crucial for meeting the stringent regulatory requirements necessary for advancing clinical trials and achieving commercialization.
Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed, stated, "Optimi's psilocybin extract capsules align with the strict quality and regulatory standards we require for our clinical programs and drug development. This partnership ensures we have the resources necessary to advance our Phase IIb trial, pursue our IND registration, and prepare for the next stages of global research initiatives and commercialization efforts."
Future Phase III Studies and Commercialization
The agreement with Optimi Health not only supports the current Phase IIb trial but also lays the groundwork for future Phase III registrational trials and potential commercialization of psilocybin-based therapeutics in palliative care. By securing a reliable supply of GMP-certified psilocybin and comprehensive CMC support, Psyence Biomed is well-positioned to advance its drug development pipeline and address the unmet mental health needs of palliative care patients worldwide.
