Creso Pharma Ltd’s (ASX:CPH) (FRA:1X8) target acquisition company Halucenex Life Science Inc has secured an additional 10 grams of synthetic psilocybin from its manufacturing partner and Canada’s only pharmaceutical-grade synthetic psilocybin producer for use in R&D initiatives and future clinical trials.
The additional 10 grams adds to Halucenex’s existing inventory of 12.3 grams and takes its total pharmaceutical-grade psilocybin inventory to 22.3 grams.
Halucenex, which now is one of the largest holders of single batch GMP-grade synthetic psilocybin in Canada, can ramp up clinical trials and R&D initiatives that are scheduled to start in the third quarter of 2021, subject to licencing and regulatory approvals.
“Major development and opens a number of doors”
Creso Pharma non-executive chairman Adam Blumenthal said: “Halucenex is now one of the largest holders of single batch GMP-grade synthetic psilocybin in Canada.
“This is a major development and opens a number of doors for Halucenex in the medium and long term.
“Once it secures its licence from Health Canada, Halucenex will have the capacity to progress a number of R&D initiatives, which have the potential to unlock new drug delivery methods and combinations, potentially leading to a higher level of care through alternative treatment methods.
“We look forward to working with Halucenex and its existing partners to progress these research initiatives.”
“Halucenex and the Creso group more broadly continues to make steps forward.”
Additional supplies
Halucenex, now, can increase the total number of clinical trial participants in its pending Phase II clinical trial, ensuring all participants in future Phase II and Phase III trials are treated with the same consistent GMP batch for tracking and traceability purposes.
Further, the additional supply will allow Halucenex to conduct GMP formulations in future delivery methods for faster onset, as well as integrate other beneficial compounds, including those in Creso Pharma’s current product range to create tailor-made solutions for new drug development.
This will be undertaken with its suite of leading clinical partners following receipt of a controlled drugs and substances Dealer’s License from Health Canada.
There is a continued and growing interest in psychedelic-inspired medicines and a bottleneck in the supply of synthetic psilocybin.
Significantly de-risks clinical trial timelines
Halucenex founder and CEO Bill Fleming said: “There is strong competition and a bottleneck in the current psilocybin supply chain, so to nearly double our inventory is a significant value accretive event, which significantly de-risks clinical trial timelines.
“Securing additional inventory also highlights the strength of our relationship with Canada’s only synthetic psilocybin manufacturer.
“The additional supply will unlock a number of benefits.
“Importantly, it comes from the same batch as our previous inventory, which provides essential latitude.
“We have a number of research and development initiatives planned over the coming months including new delivery integrations for faster onset and potentially enhanced efficacy, as well and the integration of our compounds in collaboration with clinical partners and we look forward to updating shareholders progressively.”
Broaden addressable market
Creso Pharma plans to leverage the existing product suite to explore the potential to combine psilocybin with CBD and hemp extracts used in current offerings.
The company is confident that the new delivery methods and drug compounds may considerably broaden Halucenex’s total addressable market and will provide another major de-risking event for Halucenex ahead of the proposed acquisition.
The US OTC listing
Creso Pharma is also working towards US OTC listing and expects DTC eligibility, which allows real-time electronic settlement, to be granted soon.
Blumenthal said: “This will unlock considerable benefit for shareholders.
“We are very excited to share some of the developments the company has been working on in the coming months.”