Naturally occurring compound psilocybin – the psychedelic found in certain species of mushrooms – has been around in the public imagination for a long time.
After a long period of prohibition starting in the early 1970s, it is currently experiencing a resurgence in clinical interest, with more than 200 studies underway to try to bring the compound to market as a therapeutic drug to treat an enormous range of unmet needs.
Australian biotech Tryptamine Therapeutics Ltd (ASX:TYP) is targeting solutions to indications as diverse as binge eating disorder and Irritable Bowel Syndrome (IBS) – but the company is steering a different path to market than many other psychedelic-focused companies.
Unlike it competitors, Tryptamine is agnostic about the asset being a psychedelic compound and focused on the end treatment, leveraging the drug’s therapeutic potential to create innovative, commercially viable treatments.
“Our reason for being is not because of psychedelics,” says CEO Jason Carroll.
“The idea behind the business is that we look at ways we can develop and deliver innovative opportunities that we can turn into commercial successes and in a reliable way for patients, within the psychedelic space.”
Well-known psychedelic compound
Psilocybin was originally synthesised in 1958 and – following a long period of prohibition coming out of the 1970s – has experienced a resurgence in recent years, with more than 200 global studies examining its efficacy.
Because of its natural origins, proprietary protections are unattainable for psilocybin itself.
Instead, the company is focused on getting three layers of patent protection that cover the product, the process of infusion and each specific indication it treats.
“The idea is that you find an opportunity within a certain disease state or an indication where you go in first and then you deliver the treatment and you get to get a result,” Carroll says.
“And if you get a result that shows the product is effective, then you can get a proprietary intellectual property protection around that indication itself.
“It's as powerful as a standard patent around a molecule because other companies can't start exploring that disease state because you were there first.”
On its own this is no mean feat, but CEO Jason Carroll says such is the groundbreaking nature of the company’s work, that “every study we’re working on is a world first."
The company’s comprehensive protection strategy not only stands to enhance its shareholder value but also underscores the potential for significant advancements in treatment options for patients with difficult-to-treat conditions.
How the brain processes pain
IBS affects up to 20% of Australians and 15% of the US population and represents a significant unmet medical need, impacting productivity and quality of life.
The hypothesis linking IBS to both gastrointestinal and neural components is an example of the innovative nature of the company’s research – which explores the neural component of pain and how the brain processes it.
In the case of IBS, Tryp is exploring the gut-brain relationship through ongoing and future clinical trials.
More broadly, psilocybin's role in resetting neural pathways is central to the company’s therapeutic strategy, and potentially offers relief for conditions like fibromyalgia and phantom limb pain, which traditional treatments fail to adequately address.
IV offers precise dosing and better efficacy
Another significant point of difference for Tryptamine is its approach to drug delivery.
The company favours intravenous (IV) infusion of psilocybin over oral administration.
IV infusion ensures consistent delivery and efficacy by bypassing the metabolic variability inherent in oral consumption.
“With IV, you avoid the need for the person that's taking the product to then metabolise it,” Carroll says. “And therefore, you can understand how much active ingredient they need in their brain to form a result.”
This method allows for improved efficacy, safety, faster onset, precise dosing and reduced variability and intervention in patient outcomes, bypassing a critical challenge in administering psychedelic therapies across a wide range of patients and indications.
IV makes the therapeutic session shorter and more effective, which is better from the point of view of the health system and the patient.
While the company believes IV provides the optimal delivery to the body, it is still running trials based on an oral formulation, which is easier to access and provides an avenue to de-risk the business.
“The idea being that if we see a signal in oral psilocybin trials while knowing that the active ingredient still is thin, we'd be pretty sure that when we do IV studies here in Australia that it's going to come through as a positive result.”