RFK Jr and Donald Trump on the campaign trail. Pic: Anna Moneymaker/Getty Images
Health & Biotech
It has been an interesting year for the medicinal psychedelics sector globally. Speculation is mounting about how President-elect Donald Trump’s return to the White House might favourably impact the sector.
Much of the optimism stems from the appointment of Robert F. Kennedy Jr – aka RFK Jr – to head the US Department of Health and Human Services in Trump’s upcoming administration.
RFK Jr has championed psychedelics research and written on X about his views including support for veterans with PTSD and the “aggressive suppression” of psychedelics, alongside other unconventional health treatments.
FDA’s war on public health is about to end. This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything…
— Robert F. Kennedy Jr (@RobertKennedyJr) October 25, 2024
A policy shift could mark a radical departure in the US from decades of the government’s “war on drugs”, dating back to Richard Nixon’s administration in the 1970s, which effectively halted legitimate research into psychoactives including psilocybin, MDMA, LSD, DMT, and related substances.
In August, the FDA rejected Lykos Therapeutics’ application to use MDMA (ecstasy) to treat PTSD, citing concerns about limited clinical data and requesting further study.
Beyond RFK Jr, Trump is surrounded by prominent pro-psychedelics voices including Tesla founder and head of the new Department of Government Efficiency Elon Musk. (Ed’s note: Actually an advisory commission, and … yes … that spells DOGE).
Billionaire venture capitalist Peter Thiel, a mentor to Vice President-elect J.D. Vance, has heavily invested in Nasdaq-listed psychedelic drug company Atai Life Sciences.
Additionally, several Republican congressmen advocate using MDMA to treat PTSD in veterans, highlighting a growing bipartisan interest in the therapeutic potential of psychedelics.
US government support could have ripple effects globally, signalling a new era for psychedelics research and regulation.
In 2023, Australia became the first country to approve the use of MDMA for PTSD and psilocybin for treatment-resistant depression under the authority of a TGA authorised prescriber psychiatrist alongside close therapeutic support.
In further developments in the sector this year, the European Medicines Agency (EMA) announced plans to establish guidelines for medical psychedelics.
Several nations have also advanced regulatory frameworks for the therapeutic application of psychedelics, including the UK, Canada and Switzerland.
Psychedelics research is also growing worldwide. Leading universities and medical institutions are among organisations undertaking trials and research into psychedelics with promising results including Monash University in Melbourne, Johns Hopkins in the US along with Imperial College and Kings College, both in London.
On the ASX there are only three companies focused on psychedelic developments.
Tryptamine’s lead asset TRP-8803 is scalable psilocin-based IV-infusion formulation, which the company claims has neuroplastic benefits.
Psilocin is the active agent of psilocybin – a psychedelic compound found in ‘magic mushrooms’.
Neuroplasticity is the ability of neural networks in the brain to change through growth and reorganisation.
Treatments which improve neuroplasticity are thought to cause adaptive structural and functional changes within the brain.
Tryptamine claims benefits of TRP-8803 include a faster action time, with more precise control of the depth and duration of the participant’s psychedelic state.
The company said TRP-8803’s major advantage is its reversibility, allowing for treatment to be halted quickly if patients experience adverse events.
Tryptamine said this critical safety benefit cannot be achieved using oral dosing. The company recently announced that all objectives of its phase 1b study of TRP-8803 in healthy volunteers had been met and it could now progress to phase II clinical trials.
The company said the phase 1b study – conducted with therapist support – was the first and only time that an IV-infused psilocin solution had been used globally.
Tryptamine is also developing a synthetic oral psilocybin TRP-8802 and has claimed positive results from a phase 2a study to treat fibromyalgia pain and a phase 2a study to treat binge eating disorder.
A phase 2a study of TRP-8802 to treat irritable bowel syndrome (IBS) is currently underway.
Tryptamine CEO Jason Carroll told Stockhead interest in the use of psychedelic-based medicines for mental health conditions was reaching an inflection point.
“This is primarily driven by the need for alternative treatment pathways, as well as increasing acceptance from practitioners around the legitimacy and potential of psychedelic compounds as pharmaceutical products,” he said.
“After 20 years of developing complex biologics for rare diseases, the global pharmaceutical industry is finally waking up to the value found in the development of small molecules to treat myriad disorders in neuropsychiatry.”
Bioxyne’s wholly-owned subsidiary Breathe Life Sciences (BLS) in late November successfully imported the active pharmaceutical ingredients to manufacture the first batch of Australian GMP-certified Psilocybin and MDMA products.
In February Bioxyne announced that BLS had become the first Australian company to be awarded a Good Manufacturing Practice (GMP) Licence allowing the manufacture of novel patient-ready medicines containing psilocybin and MDMA.
BLS expects to manufacture sufficient patient-ready products to supply up to 500 doses of each Psilocybin and MDMA to Australian patients (via the Authorised Prescriber Scheme) and clinical trials research in Australia and abroad, with partners like CY Biopharma AG.
Later stage in-human clinical trials require medicines to be manufactured by a GMP-licensed manufacturer.
BLS expects its Australian domestic manufacturing capabilities of Psilocybin and MDMA products will enable phase II and phase III clinical studies to progress.
“Psilocybin and MDMA have amazing potential to completely change the way the world treats depression and other mental illnesses,” Bioxyne CEO Sam Watson told Stockhead.
“Governments and regulatory authorities are starting to realize this potential and I feel the momentum is set to continue as more trial results show efficacy and safety.”
Emyria evolved from a chain of specialist medicinal cannabis clinics that listed on the ASX in 2020 and is now focused on researching and developing psychedelics to treat select mental health and neurological disorders.
The Andrew “Twiggy” Forrest backed company’s current focus is on using MDMA for treatment-resistant PTSD.
CEO and managing director Dr Michael Winlo told Stockhead about 1.5 million Australians suffer from PTSD, with up to half of cases treatment-resistant.
“The incidence of conditions like PTSD are rising and putting a significant burden on our health system,” he said.
“These new treatments hold great promise and are worthy of our effort and investment.”
In 2023 Emyria purchased Perth’s Pax Centre, a multi-disciplinary psychological trauma centre.
In April, the company opened its own Empax Centre, dedicated to the delivery and real-world evaluation of new mental health treatments such as MDMA-assisted therapy for individuals with treatment-resistant PTSD.
Currently Emyria’s centres have two TGA-authorised prescribing psychiatrists for MDMA and psilocybin and the company has recently supported four new psychiatrists obtain their authorised prescriber status.
Emyria has also been approached by several private health insurers to develop funding pathways, a sign mainstream support is building.
Through his family’s health tech investment fund Tenmile, Forrest has become a backer of Emyria. Tenmile has also invested in unlisted Psylo, which works with psychedelics as well.
“Global interest in psychedelics is certainly growing significantly and is likely to continue with a great need for better mental health treatments,” Winlo said.
At Stockhead, we tell it like it is. While Tryptamine Therapeutics and Bioxyne are Stockhead advertisers, the companies did not sponsor this article.
Health & Biotech
Health & Biotech
Health & Biotech
