NEW YORK, Sept. 16, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today issued the following update to shareholders:
It has been an eventful and productive few months since my last letter in March, and I wanted to take this opportunity to update you on our recent progress, as well as key milestones that we are focused on going forward.
Phase IIB Trial in Palliative Care Initiated in Australia
Beginning with our lead clinical program, which is evaluating nature-derived psilocybin in conjunction with psychotherapy as a potential treatment for Adjustment Disorder in Palliative Care, we recently announced the initiation of patient screening in our Phase IIb clinical trial that we are running in Australia. Together with our partners, Fluence and iNGENū, we will endeavor to enroll this study as efficiently as possible, and we look forward to topline data in the back half of next year that, if positive, will support the initiation of a pivotal Phase III trial as soon as practicable thereafter. We see this as a big value inflection point for our company.
Strengthened Clinical Supply of Natural Psilocybin
To better support this program, we have partnered with Optimi Health through a non-binding Letter of Intent (LOI) whereby Optimi will be our exclusive supplier of GMP nature-derived psilocybin extract for both our Phase III trial (assuming the Phase IIb study is successful) as well as subsequent commercialization. This LOI gives us confidence that we will have a reliable supply of high-quality GMP nature-derived psilocybin extract as we continue to advance our Adjustment Disorder clinical program.
Second Indication: Alcohol Use Disorder and other Substance Use Disorders
We also announced our second development indication, which will evaluate GMP nature-derived psilocybin as a potential treatment for Substance Use Disorders (SUDs), including Alcohol Use Disorder (AUD). We plan to focus initially on AUD, and, to that end, we signed an agreement with Psylabs to be the exclusive supplier of highly purified psilocybin extract exclusively for these indications. SUDs represent a significant burden to society, with as many as 44.4 million people aged 18 and over in the U.S. alone diagnosed with an AUD or SUD in 20211.
Numerous prior academic studies suggest that psilocybin, when combined with psychotherapy, can be a safe and effective treatment option for these individuals2,3,4 – something that we aim to confirm in rigorously designed clinical studies.
Acquisition of Second Phase IIb Asset
Staying on the topic of AUD for a moment, to further bolster our development efforts, we signed a conditional binding term sheet for the acquisition of psilocybin-based drug developer Clairvoyant (the “Proposed Acquisition”). This acquisition, when completed, makes strategic sense for Psyence for several reasons. First, it introduces a synthetic psilocybin-based therapeutic candidate that nicely complements our ongoing nature-derived psilocybin development programs. Additionally, it efficiently expands our pipeline into AUD – a high-value indication – with a regulatory pathway that, if successful, will transition us to a commercial-stage, revenue-generating company. Clairvoyant is currently executing a Phase IIb clinical trial in AUD, with topline data expected in early 2025. Closing of this acquisition is contingent upon the completion of due diligence and customary closing conditions.
Together, these initiatives give us line-of-sight to two critical Phase IIb data readouts, in two separate indications, in the relative near-term: first, data from Clairvoyant’s ongoing trial in AUD in early 2025, followed by results from our trial in Adjustment Disorder in the second half of 2025.
Strengthened Financial Position
Finally, to ensure that we have the critical funding required to advance these initiates, we entered into agreements that are expected to provide us with sufficient capital to execute our strategy as outlined above.
In closing, by announcing our second indication and strengthening our pipeline and supply chain, we continue our journey to become a fully-fledged, vertically integrated life science biotech company. While conditions in the capital markets continue to be challenging, we believe that our many accomplishments over these past months position us to be a leader in the rapidly emerging field of psychedelic-based therapeutics development for mental health and related disorders.
I look forward to keeping you apprised of our continued progress. Thank you for your ongoing interest and support.
Neil Maresky, MD
Dr. Neil Maresky
Chief Executive Officer
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature-derived and non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. 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, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. Psyence is initially focused on mental health disorders in the context of Palliative Care.