• The TGA has down-scheduled MDMA and psilocybin as of July 1st
  • There are 5 stocks on the ASX with a hand in the psychedelics space

 

Back in February the Australian Therapeutics Goods Administration (TGA) made the landmark decision to down-schedule MDMA and psilocybin to Schedule 8 ‘Controlled Medicines’ from the 1st of July 2023.

Stockhead’s Eddy Sunarto explains it in excellent detail here, but essentially, the decision opens the door for the previously Schedule 9 ‘Prohibited Substances to become mainstream medicine for the treatment of Post-Traumatic Stress Disorder (PTSD) and for treatment-resistant depression – if they’re prescribed by a qualified psychiatrist and used therapeutically in a controlled medical setting.

According to Incannex (ASX:IHL) director and psychedelic clinics business lead Peter Widdows, while there is no data (yet) to support it, he believes the market opportunity could be around the $2 billion mark in Australia.

“That’s working back from the number of people that suffer from certain conditions and then the number who will seek treatment from that and then the estimated pricing,” he said.

“Globally, I think it’s probably closer to a $63 billion market.”

The company is gearing up to launch the country’s first psychedelic-assisted psychotherapy clinic in Melbourne and start treating patients in Q3.

“It’s a prototype clinic but it’s a commercial-scale prototype capable of treating 600+ patients in normal working hours per year – substantially more if we extend the hours,” Widdows said.

“Once we’ve got that running smoothly, we’ll roll out very quickly to other clinics, targeting Sydney first, then probably a second clinic in Melbourne, then Brisbane, Adelaide, Perth, Gold Coast etc. with an eye on the international market as well.

“That’s regulatory conditional, but where regulations change and where we believe there’s a market opportunity, we’ll roll out clinics.”

Not to mention there’s a real community need for these treatments.

“The effect of depression and PTSD and anxiety on society is very high, and these treatments are showing good clinical results,” Widdows said.

“There’s a real community need for it, it’s a very big market and it will have a very big impact on society. 

“The final outcome has always been service delivery to actually provide a proper medical service and make a real difference.”

 

IHL share price today


 

Which other ASX stocks have a stake in psychedelics?  

 

CRESO PHARMA (ASX:CPH)

Soon after the landmark TGA announcement in Feb, Creso Pharma flagged that its wholly owned subsidiary Halucenex Life Sciences Inc will pursue Australian market entry.

Halucenex is already a licensed psilocybin supplier under Health Canada’s Special Access Program and is well advanced in psychedelic assisted therapy R&D – and they are currently advancing a Phase II clinical trial to test the efficacy of psilocybin on treatment resistant PTSD which is expected to complete in H1 2023.

There are currently 20 recruited patients in the single–arm, open-lab trial that all suffer from the condition, as well as other mental illnesses such as (but not limited to) anxiety, suicidal thoughts, ADHD, depression, and anger.

CPH is confident the real-world data generated from the Phase II trial will provide a strong foundation for the registration of its Lucenex branded synthetic psilocybin product, as a potential treatment route in Canada and Australia, pending further regulatory requirements.

 


“The TGA’s decision provides considerable validation of Halucenex’s work to date, and highlights the significant opportunity Creso Pharma has as an early stage pioneer of medical psilocybin,” CEO and MD William Lay said at the time.

“Halucenex’s clinical trial is advancing well, and we are confident that data generated will provide a much greater insight into how Lucenex can be used as a potential treatment route for debilitating health conditions.”

 

EMYRIA (ASX: EMD)

In March the Andrew Forrest’s Tattarang-backed biotech company announced collaboration with The Pax Centre, Australia’s leading trauma-focused psychiatric services specialising in the treatment of complex trauma to develop a scalable program to provide safe MDMA-assisted therapy in the community for patients with treatment resistant PTSD.

Under the deal, PAX will provide specialist psychiatrists, trained therapists, and facilities; while Emyria will manage clinical trial design, Real-World Data generation, data monitoring and the supply of MDMA tablets.

The care program will commence as an ethics-approved clinical trial (with Emyria as sponsor), until PAX psychiatrists have obtained Authorised Prescriber status, and a cost model has been developed.

PTSD is a significant mental health issue, in the US, approximately 10 million people suffer from PTSD with total excess economic burden costs estimated to be around $232.2 billion per year. 

In Australia, there are approximately 1 million sufferers, and with around 30-50% of patients showing resistance to standard treatment there has been increasing interest in novel treatment approaches. 

The company is also working on an MDMA analogue library with the University of Western Australia to develop faster-acting MDMA which could shorten treatment sessions and increase the number of patients potentially benefiting from the therapy. 

The library holds a total to over 150 compounds, and EMD anticipates selecting lead compounds for pre-Investigational New Drug Application (IND) enabling studies (a vital step in bringing a drug to market) in the second half of 2023, as it advances its preclinical program. 

EMD has already secured clinical-grade and patient-ready supply of MDMA and aims to establish a network of trained therapists and psychiatrists to provide MDMA-assisted therapy to appropriately diagnosed patients once the regulation changes come in. 

 

LITTLE GREEN PHARMA (ASX:LGP)

Cannabis player LGP announced in March that its subsidiary Reset Mind Sciences would partner with Health Insurance Fund of Australia (HIF) to establish a proof-of-concept mental health treatment facility that could deliver psychedelic assisted psychotherapy to patients.

The parties will also undertake a health economics study to provide HIF (Health Insurance Fund of Australia) with the real-world data necessary to inform potential member coverage for this treatment.

Plus, the parties agreed to a period of exclusivity to negotiate joint development of further treatment centres based on the initial concept. 

Reset already has Human Research Ethics Committee (HREC) approval to conduct its clinical trial into the efficacy and safety of psilocybin-assisted psychotherapy (PAP) involving family members compared to standard PAP for adults with treatment resistant major depressive disorder. 

Recruitment for the trial is anticipated to commence in the second quarter of CY2023 with the trial expected to run for approximately 12 months. 

And Reset is almost ready on the supply side, having recently completed construction of its special purpose mushroom cultivation facility with final site commissioning underway and mushroom cultivation activities expected to commence in the coming weeks. 

 

MGC PHARMA (ASX:MXC)

The final stock in the burgeoning sector is MGC, which earlier this month scored permission from the Slovenian Ministry of Health to undergo scientific research on psilocybin – including to develop analytical methods, research physical-chemical properties of the compound, and develop pharmaceutical forms that would be suitable for administration in the country.

This means the company can research, develop and manufacture for third parties, which has the potential to open up new business units and future revenue streams.

“We are pleased to have obtained permission from the Slovenian Ministry of Health to undertake pharmaceutical research with psilocybin, which puts the company at the forefront of experimental, pharmaceutical research,” said MGC Pharma CEO, Roby Zomer said.

“Whilst we continue to focus on our core development pipeline of CimetrA and CannEpil, we look forward to working with other pharmaceutical partners to establish the properties of psilocybin and demonstrate how it could be used to develop medicines to treat people with debilitating conditions.”

 

CPH, EMD, LGP and MXC share prices today:

 

 

At Stockhead we tell it like it is. While Incannex, Creso Pharma and MGC Pharmaceuticals are Stockhead advertisers, they did not sponsor this article.

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