Little Green Pharma Ltd’s (ASX: LGP) wholly-owned subsidiary and operator of LGP’s psychedelics business, Reset Mind Sciences Limited, has received Human Research Ethics Committee (HREC) approval for a major trial into a psilocybin-assisted psychotherapy (PAP). The proposed 12-month, single-centre, randomised, open-label, parallel group (two-arm), superiority clinical trial will investigate the efficacy and safety of PAP involving family members compared to standard PAP for adults with treatment resistant major depressive disorder.
The grant of the HREC approval for the Clinical Trial is the result of a more than 18-month development and approval process in cooperation with key clinical trial personnel from University of Western Australia and Edith Cowan University.
The Clinical Trial builds on the increasing body of research globally into the use of psilocybin to treat depressive related conditions by incorporating key family members into the preparatory and integration therapy sessions that precede and follow the psilocybin administration sessions.
The Trial has taken on added significance and relevance given the TGA’s announcement on 3 February 2023 that it had changed the classification of psilocybin within certain defined parameters for the treatment of Treatment Resistant Depression from 1 July 2023.
The Trial allows Reset to test and refine best practice psychotherapy protocols to accompany administration of psilocybin to trial participants.
Recruitment for the Trial is anticipated to commence in the second quarter of 2023 with the trial expected to run for approximately 12 months.
The trial will include 60 participants and will be conducted at the Harry Perkins Institute of Medical Research in Perth, Western Australia in conjunction with Fiona Stanley Hospital. It is expected to be the first clinical trial to be conducted in Western Australia using psilocybin.
We’re focused on testing and refining psychotherapy protocols and developing a network of clinicians with real world experience in the administration of psychedelic assisted psychotherapy,” Reset Mind Sciences CEO, Shaun Duffy, said.
“They’re our primary objectives here and we believe the work has taken on even more importance in the wake of the recent decision by the TGA.
“The trial will be one of the first psilocybin assisted therapy trials in Australia and we trust it will contribute meaningfully to the clinical evidence supporting the use of psilocybin and other psychedelics for the treatment of chronic mental illness in Australia.
“Given we are investigating the condition allowed by the TGA for prescription of psilocybin from 1 July 2023, we anticipate the clinical evidence we obtain will be highly instructive in the treatment of patients under the new regime announced by the TGA.”
Mental illness in Australia
Since COVID-19, the rate of mental illness and behavioural conditions in Australia and globally have been increasing, with the full impact on COVID-19 on mental health conditions still unknown. Today, mental illness is the most common chronic illness in Australia, with one in five Australians having a mental or behavioural condition (up 20% from 2014/15) and 10.4% of Australian having depression or feelings of depression.
Proposed Reset demerger
The proposed demerger of Reset from the LGP Group remains a priority and following the receipt of HREC approval for the Clinical Trial and the recent announcement by the TGA, the demerger will proceed as a priority. The ultimate timing of the demerger is subject to prevailing market conditions. Upon the demerger Reset will reimburse LGP for certain costs it has incurred prior to the demerger.
Reset is currently developing a business model designed to advantageously position the company for the evolution of the Australian psychedelics industry, with Reset currently undertaking concurrent mushroom-based psilocybin product development and clinical trial and research streams to enable both product and service delivery through an integrated supply pathway.