Latest news with #TryptamineTherapeutics
The Australian
4 days ago
- Business
- The Australian
Tryptamine cleared for BED trial supply
Tryptamine trial partner Swinburne University receives key permit for world-first clinical trial of IV-psilocin (TRP-8803) to treat binge eating disorder Permit allows Tryptamine to start supply of TRP-8803 to Swinburne ahead of first patient dosing Patient screening progressing well with initial enrolment this month and first dosing this quarter Special Report: Tryptamine Therapeutics is edging closer to first patient dosing in its world-first clinical trial for binge eating disorder (BED) with TRP-8803, an intravenously infused (IV) formulation of psilocin designed for controlled and consistent delivery of the psychedelic therapy. Tryptamine Therapeutics (ASX:TYP)has secured key regulatory approval to supply its TRP-8803 product to Swinburne University, which is conducting the trial in collaboration with the company. Swinburne University has received a 'Permit to purchase or otherwise obtain poisons or other controlled substances for industrial, educational or research purposes' from the Department of Health, Victoria. The permit allows Tryptamine to start supply of TRP-8803 to the university, ahead of first patient dosing. Tryptamine said batches of the formulation were expected to be delivered in the near term, ensuring ample supply for the trial. Dosing forecast for this quarter Following the start of patient recruitment in July, Tryp advises that patient screening is progressing well. Several potential participants have completed the initial application processes and will move through to face-to-face interviews next week. Initial enrolments are then set to start with commencement of baseline data collection before administration of first dosing forecast for this quarter. The open-label trial will recruit a total of 12 patients suffering from BED, in two six-person cohorts. Cohorts will be administered two doses of TRP-8803, 14 days apart, in a monitored setting and following psychotherapy and integration. Cohort 1 will receive a mid-range dose, while the second cohort will be administered a high-range dose. The trial's primary endpoint is to assess TRP-8803's safety when administered twice in BED patients and during follow-up through the 12-week period after first dose. Secondary and exploratory objectives include: Evaluating ability of inducing the psychedelic state with TRP-8803 in a BED population; and Determining clinical activity and effects of TRP-8803 on frequency of binge-eating episodes and other weight-related indicators in a BED population four weeks post second dosing. Tryp will also use resulting data to explore TRP-8803's on comorbidities that BED patients may suffer from. The data will be used to finalise plans for future clinical development opportunities. 'Another milestone' in Tryptamine's journey CEO Jason Carroll said Tryptamine continued to make very strong progress on its trial for BED with TRP-8803 in conjunction with Swinburne University. 'The receipt of this permit marks another milestone in our journey to deliver a potential treatment for BED, which is a far-reaching and debilitating condition,' Carroll said. 'Our focus will now shift to supplying Swinburne with TRP-8803 for use in the trial, as well as assisting with patient enrolment. 'Given the level of enquiries to date and progress with initial patient screening, we remain on track for first enrolment this month and first dosing this quarter.' 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.
News.com.au
29-06-2025
- Health
- News.com.au
Green light for psychedelic drugs trial to treat binge-eating
Australian researchers will soon deploy a psychedelic compound found in 'magic mushrooms' to treat binge-eating in a world-first clinical trial. Experimental healthcare company Tryptamine Therapeutics announced the radical trial in a statement to the Australian Securities Exchange this week, telling investors Swinburne University would conduct the open-label research on 12 patients suffering from binge-eating disorder. Open-label means there are no placebos involved and all patients and researchers know what is being administered. The patients will receives two doses of TRP-8803, a psilocin-based IV infusion. Psilocin, which is produced when psilocybin is broken down in the body, is a psychedelic compound that triggers changes in mood, perception and thinking patterns. Cognitive neuropsychologist Professor Susan Rossell, from Swinburne, designed the trial with Tryptamine and told NewsWire she hoped the psychedelics would open up the trial's participants to new ways of thinking. 'What we have found in other psychedelics work is that the psychedelic itself opens up people to think differently,' she said. 'And one of the things that we know with a lot of mental health conditions, is they start to have repetitive thinking and it becomes very rigid. 'So people with binge eating disorder, 'I need to consume lots of food to help with my emotional issues'. 'They are in that very stuck, rigid thought pattern and they can't find other ways to deal with their life stressors.' Binge-eating is the uncontrollable consumption of food and can lead to a range of serious health problems, including social isolation and weight gain. It is the second most common eating disorder in Australia. In the US, an estimated 1.25 per cent of adults experience the disorder each year and 1.6 per cent of teenagers aged 13 to 18 are affected. 'It's extraordinarily costly,' Professor Rossell said. The trial is expected to run for three to four months, with initial results due at the end of the year. Tryptamine CEO Jason Carroll said the primary objective of the trial was to assess TRP-8803's utility in treating the disorder, but it could also generate insights into how the product might help with other neuropsychiatric disorders. 'With patient recruitment initiatives now underway, we look forward to first enrolment and the commencement of baseline data generation from participations, prior to first patient dosing,' he said. Clinical trials involving psychedelics to treat medical conditions are growing around the world, but the impacts are not yet clear. Psychedelic drugs are illegal in Australia and there is evidence that consuming mind-altering substances can lead to adverse outcomes. A study on single-dose Psilocybin for treatment-resistant depression, funded by psychedelics company Compass Pathways and published in the New England Journal of Medicine in 2022, revealed mixed results, with most participants experiencing 'adverse events'. 'Adverse events occurred in 179 of 233 participants (77 per cent) and included headache, nausea, and dizziness,' the researchers found. A small number of participants suffered serious negative impacts, the study revealed, including suicidal ideation and intentional self-injury. Professor Rossell said the Swinburne trial would be safe. 'I don't know whether these medications are going to work or not but I've worked with them now for two years and I haven't had anything negative happen with anybody in my trials, in the right and safe environment,' she said. She also said the use of an IV solution added an additional layer of control. 'The IV is even more safe,' she said. 'If we start to be aware that the person is having an unpleasant reaction, we can stop it straight away with the IV. 'With the oral preparations, they have to work through it. And it can leave people with some unpleasant feelings.' Tryptamine, a listed company with a market capitalisation of $43m, stresses the 'confirmed reversibility' of TRP-8803 as a key selling point for the product. 'This formulation aims to overcome several limitations of oral psilocybin, including significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the experience and reducing the overall duration of the intervention to a commercially feasible time-frame,' the company states. 'TRP-8803 also provides dosing flexibility and the ability to terminate treatment if the patient is experiencing an adverse event.' The company held $4.6m in cash as of March 31.
News.com.au
26-05-2025
- Business
- News.com.au
Tony's Takeaway: Tryptamine Therapeutics and the psychedelic sector
Tony Locantro has been a client advisor/investment manager in the stockbroking industry since 1998. He's focused on the small cap and emerging companies with a strong interest in identifying those in the mining, biotech and industrial sectors that offer growth potential. He also delves into the psychology of speculation and provides regular insights on a number of social media and finance related outlets. This week, Tony checks out an emerging psychedelic healthcare sector with some big developments and an Australian company in Tryptamine Therapeutics (ASX:TYP) who has recently made an eye-opening appointment of a global pharmaceuticals leader. The views, information, or opinions expressed in this video are solely those of the author and do not represent the views of Stockhead. Stockhead has not provided, endorsed or otherwise assumed responsibility for any financial product advice contained in this video. Viewers should obtain independent advice based on their own circumstances before making any financial decisions.
