Incannex Healthcare to benefit from landmark TGA decision on psychedelics

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By Filip Karinja - 

The Therapeutic Goods Administration (TGA) has announced that from 1 July 2023, medicines containing psilocybin and MDMA can be prescribed by authorised psychiatrists.

In an announcement made on Friday, the TGA stated it will permit the prescribing of psilocybin for treatment-resistant depression (TRD) and MDMA for the treatment of post-traumatic stress disorder (PTSD).

For these specific uses, psilocybin and MDMA will be listed as Schedule 8 controlled drugs rather than Schedule 9 drugs that are effectively prohibited from being distributed to patients under any conditions.

World first for psychedelics

Australia is now the first country in the world to officially recognise MDMA and psilocybin as medicines.

The decision has been welcomed by the psychiatric community as an acknowledgement by the TGA that there is a lack of options for patients with treatment-resistant mental illnesses.

It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting whereby the psychiatrist can reasonably argue their appropriate use case to the TGA.

Down scheduling of psilocybin and MDMA

Cannabinoid and psychedelic pharmaceutical development company Incannex Healthcare (ASX: IHL, NASDAQ: IXHL) has also celebrated the news.

Incannex says that it has one of the most advanced psychedelic clinical development programs in the world and the quality of the trial comfortably fits amongst the biggest psychedelic names in the space, including the likes of Atai, MAPS and Compass.

Incannex’s proprietary Psi-GAD clinical development program combines unique psychological therapy with intimate psilocybin dosage sessions to treat people with generalised anxiety disorder (GAD), which is effectively people with severe treatment-resistant anxiety.

Speaking with Small Caps, Incannex chief executive officer and managing director Mr Joel Latham said he “commends” the TGA for having the foresight to recognise psychedelics as medicines for the benefit of treatment resistant patients nation-wide.

“Incannex is an early adopter in the sector and our team, in partnership with Monash University, has achieved rapid progress with our own psilocybin project targeting the treatment of severe anxiety.”

“Our trial is truly a world first for the treatment of anxiety and we will be releasing preliminary data pertaining to 29 patients from the Psi-Gad program in March.”

He added that after being involved in the psychedelic field for almost three years now, Incannex is “well placed” to take advantage of even more opportunities as it assesses the evolving regulatory landscape.

In January, was approximately halfway through its clinical trial of 72 people with GAD.

The protocol for the trial was designed by a member of Incannex’s advisory board, Dr Paul Liknaitzky at Monash University, with Monash’s head of the Department of Psychiatry, Professor Suresh Sundram as a co-investigator.

Ethics approval for the trial was achieved in 2021 and guidance from the US Food and Drug Administration (FDA) on proceeding the R&D program to an IND has already been received.

Psi-GAD Development Program – what’s next?

Down scheduling of psilocybin for TRD is interesting for the prospects of Incannex as it is among the only major psychedelics companies actively trialling psilocybin for patients with anxiety.

Incannex says it is currently on a path to develop a psychedelic treatment for anxiety faster than any other competitor.

Subject to clinical trial results, it’s conceivable that the new TGA scheme for psychedelics could eventually extend to Incannex’s psilocybin Psi-GAD therapy.

Last month, Incannex announced that it had achieved an interim milestone of 29 patients completing primary endpoint assessments.

The 10-week patient treatment protocol includes two dosing sessions with either psilocybin or active placebo. Safety, efficacy, quality of life, and other aspects of mental and physical health are then assessed to define the benefit of the treatment.

Analysis of interim study data from Psi-GAD has begun and is being conducted by aMonitoring Board of scientific experts not part of the trial to ensure independence.

The results from this analysis will be available in March 2023, at which time Incannex says that it will provide another ASX and Nasdaq announcement.

In the January update, Incannex also stated it has not identified any material safety concerns among clinical trial participants.

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