Creso Pharma Ltd's (ASX:CPH) (FRA:1X8) target acquisition Halucenex Life Sciences Inc has signed an agreement with leading pharmaceutical contract research organisation Nucro-Technics to provide microbiology and chemistry test work for a salient delivery solution using synthetic psilocybin, which will be used in upcoming clinical trial submissions.
Under the deal, Halucenex will work with Nucro-Technics to test the stability and shelf life of psilocybin liquid formulations for use in its Phase II clinical trial.
Halucenex will have access to a good manufacturing practice-certified lab to formulate and test the bioavailability of its synthetic psilocybin compound, the ability to handle control substances for formulations of current delivery solutions and potential future methods that may have a faster onset.
The agreement will also provide Creso Pharma with the ability to develop and validate methods for potency, component identification and microbiology for botanical psilocybe mushrooms grown in the future at Halucenex.
NucroTechnics will be paid a fixed fee of C$38,202.
"Unlock significant value"
Creso Pharma’s non-executive chairman Adam Blumenthal said: “The continued progress Halucenex is making is very pleasing and we anticipate the acquisition and near-term milestones will unlock significant value for shareholders.
“Alongside Halucenex, the board and management team are continuing to work through strategies to drive growth in key markets including North America, Europe and Australia.
“Demand for our products continues to increase and we look forward to updating shareholders on developments shortly.”
Regulatory milestones in near term
Halucenex founder and chief executive officer Bill Fleming added: “Nucro-Technics has a defined area of expertise that will be instrumental in the preparations for our upcoming Phase II clinical trial.
“Further, the group complements our existing suite of industry-leading partners that will assist Halucenex in becoming a leading researcher and provider of Psychedelic-Assisted Psychotherapy.
“Management is continuing to work diligently to progress trial initiatives and we expect to achieve a number of regulatory milestones in the near term.
“The receipt of a Dealer’s License from Health Canada will provide us with another considerable competitive advantage in what is becoming a large and lucrative vertical.”
Trial to start in third quarter
Upon receipt of the Dealers License, Halucenex will apply for Clinical Trial Authorisation and commence a Phase II clinical trial, which will research the efficacy of psilocybin on the treatment of treatment-resistant post-traumatic stress disorder (PTSD).
The proposed trial is designed to be a single-arm, open-lab trial that will ultimately determine the feasibility of future trials of psilocybin in this indication.
Between 18 to 20 individuals over 18 years old, suffering from treatment-resistant PTSD, will be enrolled.
The trial is expected to commence in the third quarter of 2021, subject to receipt of all necessary regulatory approvals.
Revenue generation
Halucenex also has an affiliation with Veterans Affairs Canada via strategic adviser David Fraser, which will expedite revenue generation through sales into a market with significant demand and government backing.
Nucro-Technics
Nucro-Technics is a Canadian company that partners with pharmaceutical, biologic and medical device companies globally to assist with R&D initiatives.
The group, which has been in operation for nearly 50 years, employs over 170 scientific support personnel at its state-of-the-art 60,000 square foot facility in Toronto.
Nucro-Technics is inspected by and in compliance with the US Food and Drug Administration (FDA) and Health Canada, amongst other regulatory bodies.