Tryptamine is pioneering delivery of psychedelic medicines through IV infusion. Pic: Getty Images
Health & Biotech
Special Report: Clinical-stage biotech Tryptamine Therapeutics (ASX:TYP) is pioneering a precision approach to psychedelics, targeting precise drug blood levels in patients to minimise the risk of side effects, while maximising the benefits of treatment.
Interest in the emerging field of psilocybin – the active ingredient in magic mushrooms – has grown in recent years with various research demonstrating that psychedelics-assisted therapy holds great promise for helping people with a range of existing treatment-resistant conditions.
TYP became part of the Aussie bourse in May after Exopharm acquired Canadian-based Tryp Therapeutics and rebranded as Tryptamine Therapeutics.
CEO Jason Carroll says the company’s lead program TRP-8803 is an IV-infusion of psilocin addressing many of the current limitations associated with orally administered psilocybin used by most competitors in the field.
“When you take an oral capsule of psilocybin it has to go through the liver as every drug does when you take it orally, which is called first pass metabolism,” explains Carroll
He says after being metabolised by the liver, psilocin – the active metabolite of psilocybin – can have different effects on people.
“It can depend on how effective someone’s liver is, so the amount of psilocin the brain gets from a person with a fast metabolism may not be enough.
“For a person with a slow metabolism their brain may get more psilocin than they need.”
Carroll notes that research shows there can be a fourfold difference between the blood levels of psilocin for every patient:
“So, if you get four patients there can be four different levels of psilocin in their blood so you can get four different responses. So, some won’t get an effect and some will get a strong effect including a lot of side effects.”
Carroll says for patients to all get the same dose you need to do it in a way which is IV-directed to the brain and fast-acting.
“Capsules can take up to two hours to work or more and can last anywhere from eight to 10 hours.
“Doctors don’t know what reaction a patient may have whereas with an IV infusion within 15 minutes you have the exact psychedelic or neuroplastic state which is being sought so there’s more certainty.”
A major benefit of IV infusion, Carroll explains, is that it can reduce the medical supervision time of a patient:
“Imagine the cost saving in psychiatrists or doctors time alone where they don’t have to be with a patient for a whole 10 hour period.
“The other advantage is reversibility because once you take the capsule, you’re on that journey but with an infusion you can slow it down or turn it off.
“If someone is going through a neuroplastic state and the doctor believes they should go a little longer they can keep the infusion going for another 15 minutes.”
He says if you can keep people with the same psilocin level then doctors will know what neuroplastic state they are going to reach with greater certainty.
“No matter their gender, age or race you will get the same response because it doesn’t touch the liver and you don’t get first pass metabolism.”
TYP has several trials underway and recently announced positive results of its Phase 2a fibromyalgia study undertaken with the University of Michigan with results presented at the
IASP 2024 World Congress on Pain earlier this month in the Netherlands.
All five patients dosed with TRP-8802 – TYP’s oral psilocybin formulation – and administered psychotherapy reported an improvement in fibromyalgia pain severity, sleep, pain interference and at least three other endpoints measured one month after dosing.
Fibromyalgia is a condition associated with widespread pain. It is estimated ~1m people in Australia and ~10m people in the US suffer from fibromyalgia and there are currently limited treatment options.
TYP has also completed a Phase 2a clinical trial for the treatment of binge eating disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%.
And in July, TYP announced dosing of the first patient at Massachusetts General Hospital for a Phase 2a clinical trial investigating the treatment of irritable bowel syndrome (IBS).
“It’s the first time that MGH has administered psilocybin in a clinical setting,” Carroll says.
“They are funding the study themselves and the trial seeks to evaluate TRP-8802 in conjunction with psychotherapy in patients with IBS.
“We believe there is a significant gut-brain relationship that comes with IBS, and we expect to get results from that study as well and if we do, that will be three from three.”
However, he says TYP can look at and potentially target every disorder being treated in the world with oral psilocybin.
Where a positive clinical response is demonstrated, Carroll says subsequent studies are expected to use TRP-8803 (IV-infused psilocin).
Australia became the first country in the world last year to recognise psychedelics as medicine, after the Therapeutic Goods Administration (TGA) allowed psychedelic substances, psilocybin and MDMA, to be provided to patients.
From July 1, 2023, medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) could be prescribed by authorised psychiatrists in Australia for treating certain mental health conditions.
TRP-8803 is currently being evaluated in a Phase 1b Healthy Volunteer Study through a two-hour infusion in Adelaide.
“It’s the only time anyone is using psilocin infusion anywhere in the world so when we get that data, we will talk with the TGA and ask what we need to do for a follow up clinical trial to target specific indications,” he says.
“We will work out what kind of study they want us to do and measurements they’d like us to take.”
As the field of psychedelic medicine continues to advance, Carroll says health regulators are playing a central role in assessing the safety and effectiveness of new treatments, which to date has included some high-profile rejections.
One recent example was US company Lykos Therapeutics, which recently saw the US FDA decline approval for its MDMA-based PTSD treatment.
“The FDA’s decision highlights the importance of pursuing your clinical trial programs in accordance with the highest standards of quality and safety,” Carroll says
He notes that, as an emerging field of medicine, the pathway to market for psychedelic treatments requires “a strategic focus on stakeholder management”.
“In particular, direct engagement with regulators is key and our programs have been designed in close consultation with the US FDA and the TGA in Australia to ensure the relevant data requests are being met,” he says.
TYP has patent applications and trade secrets based on novel methods for manufacturing, formulation, dosing, and specific disease indications.
Carroll notes that the company’s first studies have been with oral psilocybin, which are faster to do and inexpensive.
However, he says the problem is there are no patents available for naturally sourced products like psilocybin.
“So you can’t just have psilocybin and say now we have a product for the next 20 or 30 years because a generic company can also provide psilocybin.”
Carroll says a pharmaceutical company must have something proprietary around what nature provides, which is what TYP is developing.
“We use the active ingredient for our next studies called psilocin and put that into a format that can be delivered faster to the brain of patients without first-pass metabolism being required.
“So, you get a product that you have a patent around from a molecule perspective and then have protection around the way it is delivered which is IV infusion in terms of TRP-8803 and then the indications we’ve chosen so you generate three layers of protection.”
Carroll has more than 30 years in the pharmaceutical sector including as an executive with some of the world’s largest healthcare companies Johnson & Johnson Pharmaceuticals (J&J).
He also worked with Janssen, the pharmaceutical arm of J&J – where he focused on commercial leadership as well as licensing and acquisition roles. Carroll says the opportunity to join TYP as CEO was a “once-in-a-lifetime opportunity”.
“You can spend your entire career trying to find opportunities and products that can make a difference to people, and I think we have that here.
“I spent a lot of time assessing companies and working with the son of the founder of Janssen, who also invested in Tryp at its IPO.
“Dr Paul Janssen who founded Janssen Pharmaceuticals was a prolific scientist and has more than seven products on the WHO’s list of essential medicines.”
In addition to his own vast experience, Carroll emphasises that TYP has a world-class management team and scientific advisory board chaired by Robin Carhart-Harris, who is a global expert on use of psychedelics for medical indications.
This article was developed in collaboration with Tryptamine Therapeutics, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
