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  • Little Green Pharma (LGP) subsidiary Reset Mind Sciences receives ethics approval to conduct a 12-month psilocybin clinical trial
  • The trial will focus on the development and refinement of best-practice psychotherapy protocols to enable the administration of psilocybin for depression
  • The trial follows the TGA’s recent decision to down-schedule psilocybin in defined circumstances for use with treatment-resistant depression
  • The trial is set the first of its kind to be conducted in Western Australia using psilocybin
  • LGP shares are up 2.44 per cent and trading at 21 cents at 2:11 pm AEDT

Little Green Pharma (LGP) subsidiary Reset Mind Sciences has been granted ethics approval to conduct a 12-month psilocybin clinical trial.

The approval was granted by the Australian Human Research Ethics Committee (HREC) and enables Reset to carry out its testing into the efficacy and safety of psilocybin-assisted therapy for patients with treatment-resistant major depressive disorder.

Reset, which operates LGP’s psychedelics business, has been working with key clinical trial personnel from the University of Western Australia and Edith Cowan University for more than 18 months to gain approval.

Principal Investigator for the clinical trial Sean Hood said the team was “well prepared” to commence proceedings.

“We have put more than 18 months of considered work into the development of our protocols and put our therapy team through an intensive training regime,” Professor Hood said.

“We believe these are the standards that are required for the responsible and professional administration of psychedelic drugs.”

The trial’s significance is bolstered by the recent announcement from the Therapeutic Goods Administration (TGA) on February 3, 2023, that it had changed the classification of psilocybin within certain defined parameters for the treatment of treatment-resistant depression from July 1, 2023.

The trial is set to be the first of its kind to be conducted in Western Australia using psilocybin.

“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,” Reset CEO Shaun Duffy said.

“Given we are investigating the condition allowed by the TGA for prescription of psilocybin from July 1, 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.”

The company said trial recruitment was expected to commence in the second quarter of 2023, with the trial to run for around 12 months.

It will include 60 participants and be conducted at the Harry Perkins Institute of Medical Research in Western Australia in collaboration with Fiona Stanley Hospital.

LGP shares were up 2.44 per cent and trading at 21 cents at 2:11 pm AEDT.

LGP by the numbers
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