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 ...
