Halucenex forms important partnership as psychedelics space heats
Creso Pharma Limited (ASX:CPH, FRA:1X8) has today announced that its acquisition target Halucenex Life Sciences Inc. has signed an agreement with Nucro-Technics, a Pharmaceutical Contract Research Organization (CRO) that is a partner to pharmaceutical, biologic, and medical device companies located all over the world.
Nucro-Technics has been in operation for nearly 50 years, employs over 170 scientific support personnel and has a 60,000 sq. ft. facility in Toronto.
Halucenex is focused on progressing clinical trials to research the efficacy of psilocybin to treat and alleviate Treatment Resistant Depression in individuals suffering from PTSD and other mental illnesses.
The company is about to begin a Phase II clinical trial that will test the efficacy of psilocybin on the treatment of PTSD.
Halucenex and Nucro-Technics will work together to test the stability and shelf life of psilocybin liquid formulations for use in Halucenex’s phase II clinical trial.
Through this partnership, Halucenex will have access to a GMP 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.
Halucuenex will also be able develop and validate methods for potency, component identification and microbiology for botanical psilocybe mushrooms grown in the future at Halucenex.
The cost to Halucenex will be a fixed fee of CA$38,202.
“Nucro-Technics have a defined area of expertise that will be instrumental in the preparations for our upcoming phase II clinical trial,” Halucenex Founder and CEO Mr Bill Fleming said.
“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 are 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.”
Trials to commence on receipt of Dealer’s licence
Halucenex is expecting to receive its Controlled Drugs and Substances Dealer’s License from Health Canada, which upon receipt will enable it to apply for Clinical Trial Authorisation and commence the Phase II clinical trial.
The proposed phase II clinical 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.
The trial will involve 18 to 20 individuals (over 18 years old) that suffer from Treatment Resistant PTSD.
Importantly, should trials be successful, Halucenex is affiliated 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.
The trial is expected to commence in Q3 2021, subject to receipt of all necessary regulatory approvals.
The Psychedelic Drugs Market size is projected to reach US$10.75BN by 2027, from US$4.75BN in 2020 growing at a CAGR of 12.36% during 2021-2027.
One of the key players is MindMed (NASDAQ: MNMD), a psychedelic medicine biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness.
It listed on the NASDAQ last Tuesday and has been public on Canada’s NEO stock exchange since March 2020. The company is capped at circa a billion dollars and in January this year began the first ever clinical trial measuring and evaluating MDMA and LSD used in combination in the human body.
The study is anticipated to take around one year to complete.
MindMed is also currently preparing a pre-IND briefing package for its Phase 2a Proof of Concept study which it plans to submit to the FDA in the second half of 2021. In addition, the Company is also evaluating a second indication in a common, often debilitating, chronic pain syndrome.
"Evidence dating back to the 1950s suggests that LSD and other psychedelics may have analgesic effects, but this treatment area remains largely untapped by companies studying psychedelics, with the majority of research focusing solely on psychiatric indications" said MindMed Chief Development Officer, Rob Barrow.
As Finfeed has previously reported, MindMed Board member Bruce Linton, who founded Canopy Growth Corp - which went from a penny stock to a $15BN market cap at its peak - recently became an advisor to CPH. Linton holds shares in CPH.
Former CEO and founder of CPH Dr Miri Wernli remains a significant shareholder of CPH and is the Executive President and Director of MindMed.
Compass Pathways is another in clinical trial phase.
Compass Pathways (NASDAQ: CMPS) is seeking to investigate the use of psilocybin therapy for treatment-resistant depression. The Company is currently conducting a phase IIb clinical trial of psilocybin therapy for TRD in 22 sites across Europe and North America. On September 18, 2020 Compass came public at $17.00 per share and has traded as high as $61.69, after an $80 million private financing round. The private round included PayPal co-founder, Peter Thiel.
MindMed and Compass are just two examples of the movement in the psychedelics space.
CPH’s pending acquisition of Halucenex will put it in the growing space and its coming US OTC listing, will put it right in the heart of the action.