Clairvoyant currently executing a fully randomized multi-country Phase IIb clinical trial evaluating a synthetic psilocybin candidate as a potential therapeutic for Alcohol Use Disorder (AUD)
Topline data from the ongoing Phase IIb AUD study anticipated in early 2025
NEW YORK, Sept. 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced that the Company has entered into a conditional binding term sheet with privately-held Clairvoyant Therapeutics Inc (“Clairvoyant”), a clinical-stage developer of psilocybin-based therapeutics based in Canada, for the proposed acquisition by Psyence Biomed of 100% of the shareholdings of Clairvoyant (the “Proposed Acquisition”). As consideration for the Proposed Acquisition, Psyence Biomed will issue US$500,000 of the Company’s common shares upon closing to Clairvoyant’s disposing shareholders, followed by potentially up to two share-based payments of US$250,000 each (payable in cash or common shares, at the Company’s election) upon the achievement of pre-specified milestones by December 2026. In addition, Psyence Biomed will advance funds in tranches of up to US$1,800,000 in aggregate to Clairvoyant in order to settle its liabilities, which consist primarily of clinical trial costs.
Clairvoyant is currently executing a Phase IIb clinical trial (CLA-PSY-201) of a synthetic psilocybin-based candidate as a potential treatment for Alcohol Use Disorder (AUD). The company has completed the enrollment and treatment of 154 randomized double blinded subjects and topline results are anticipated in early 2025.
“The proposed acquisition of Clairvoyant makes strategic sense for us for several reasons,” said Dr. Neil Maresky, Chief Executive Officer of Psyence Biomed. “First, it introduces a synthetic psilocybin-based therapeutic candidate that nicely compliments our ongoing nature-derived psilocybin development program that we are advancing in Adjustment Disorder following a life limiting cancer diagnosis in the Palliative Care context. Additionally, this proposed acquisition may expand our pipeline into another high-value indication – AUD – with a regulatory pathway that could potentially transition us to a commercial-stage, revenue-generating company.”
“With this proposed acquisition, we would have line-of-sight to two important Phase II data read-outs that, if successful, would position us as a leader in the development of psychedelic-based therapeutics to treat a range of underserved mental health and related disorders that are in need of effective new treatment options,” Dr. Maresky concluded.
“We are very pleased to join forces with Psyence Biomed as we move ahead with our ‘speed to market’ strategy for psilocybin in AUD,” stated Damian Kettlewell, Chief Executive Officer of Clairvoyant. “AUD has the widest treatment gap among all mental health disorders; while 15%1,2,3 of adult drinkers in the EU, Canada and the UK – 50 million people – are considered to be at risk for AUD, fewer than 1%4,5 seek any form of drug therapy, and currently approved therapeutics are plagued by modest efficacy and poor compliance.”
Mr. Kettlewell added, “Importantly, prior academic studies, including one study by NYU Langone published in JAMA Psychiatry in 20226, found that psilocybin-assisted psychotherapy resulted in an 83% average reduction in alcohol consumption. As well, a study of psilocybin therapy for AUD from August 2024 showed that a single psilocybin dose was safe and effective in reducing alcohol consumption in AUD patients7. These two studies suggest that there is very strong scientific rationale for continued development in this indication.”
“We look forward to topline data in early 2025 that, if positive, could accelerate development plans to approval.”
Clairvoyant’s Phase IIb clinical trial is a 24-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study evaluating two administrations of 25mg psilocybin (at weeks five and nine) in conjunction with psychotherapy compared to placebo. Twelve study sites in E.U. and Canada are participating in the trial, which randomized 154 subjects with a moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator. All study subjects expressed a desire to reduce or stop alcohol consumption.
The Proposed Acquisition shall be subject to the conclusion of a definitive share purchase agreement between the parties based on the salient terms set out in the binding term sheet. The completion of the Proposed Acquisition is subject to several suspensive conditions, including board approval, regulatory strategy approvals, and satisfactory due diligence, as well as such other customary closing conditions.
For more information on the Clairvoyant Phase II trial: https://clinicaltrials.gov/study/NCT05646303
About Psyence Biomed
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.
Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
Forward Looking Statements
This communication contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimated,” “believe,” “intend,” “plan,” “projection,” “outlook” or words of similar meaning.
Forward-looking statements in this communication include statements regarding the conclusion of a definitive agreement to the satisfaction of the parties, the fulfilment of the conditions to the closing of the Proposed Acquisition, access to the capital and liquidity required for Psyence Biomed to execute on the AUD strategy and Clairvoyant’s ability to successfully conduct its trial and deliver its intended drug product to patients. These forward-looking statements are based on a number of assumptions, including the assumptions that the parties will obtain all such regulatory, corporate, shareholder and other approvals as may be required to implement the Acquisition, the continuation of the clinical trial referred to in this news release on schedule, and the safety and effectiveness of psilocybin as a treatment option for AUD.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the inability to complete the Acquisition; (ii) the inability to recognize the anticipated benefits of the proposed Acquisition (iii) the ability of CRO to execute its obligations in respect of the clinical trial; (iv) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (v) Clairvoyant’s ability to achieve successful clinical results; (vi) Psyence Biomed’s ability to obtain regulatory approval for the proposed product candidate, and any related restrictions or limitations of any approved products; (vii) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (viii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Registration Statement on Form F-1 filed by the Company with the SEC on August 19, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
1 Global Alcohol Report. World Health Organization. 2018
2 Alcohol Use is on the Rise, but Doctors Too Often Fail to Treat it, NY Times, July 12, 2021
3 Alcohol Use Disorders. Carvalho, A.F., et al., 394: 781-792. Lancet. 2019
4 Strategies to Implement Alcohol Screening and Brief Intervention in Primary Care Settings: A Structured Literature Review. Williams EC et al. Psychol Addict Behav. 2011;25(2):206-214.
5 Morgan Stanley, Counterpoint Global Insights Psychedelics. Retrieved from: https://psychedelicalpha.com/wp-content/uploads/2022/08/Morgan-Stanley-Psychedelics.pdf
6 JAMA Psychiatry. doi:10.1001/jamapsychiatry.2022.2096. Published online August 24, 2022
7 https://www.researchsquare.com/article/rs-4947184/v1
