Clinical-stage biopharmaceutical company Tryptamine Therapeutics Ltd laid the groundwork during the March quarter to initiate a world-first clinical trial evaluating TRP-8803 for the treatment of Binge Eating Disorder (BED), while also strengthening its financial position.
Strong foundation for the future
CEO Jason Carroll said: “The work undertaken during the last quarter has laid a very strong foundation for the coming months, allowing the company rapidly advance its clinical development pathway for TRP-8803.
“The pending clinical trial with the University of Swinburne marks the first time that Tryp’s lead asset will be tested against a specific indication, alongside a leading research institution.
“The formal receipt of ethics approval for this trial post quarter-end marked another important step forward for the company and highlights the high standard of the trial framework.
“During the current quarter, the company will be focused on advancing patient recruitment, the collection of baseline data and administering first dosing.
“This will be undertaken alongside ongoing negotiations with potential research partners to broaden our clinical development pipeline, with the aim of generating additional data on the potential for TRP-8803 across a broader range of neuropsychiatric conditions that do not have clear treatment routes.”
During the March quarter, Tryp finalised negotiations with Swinburne University, culminating in a post-period Clinical Trial Research Agreement to assess TRP-8803 – a proprietary psilocin-based intravenous formulation – in adult BED patients.
The open-label trial will commence in the June quarter and recruit 12 patients across two six-person cohorts, each receiving two doses of TRP-8803 administered two weeks apart.
Binge-eating and comorbidities
The trial will primarily assess safety and feasibility, with secondary outcomes examining TRP-8803's impact on binge-eating behaviours and associated comorbidities such as anxiety, depression and post-traumatic stress disorder.
BED patients suffer from a range of other comorbidities including depression, anxiety, PTSD and compulsive behaviours, and the data from this trial are expected to provide Tryp with an indication of TRP-8803’s utility in treating these other conditions.
The initiative follows encouraging results from an earlier study using oral TRP-8802 at the University of Florida, which recorded an over 80% mean reduction in binge-eating scores.
The company had an opportunity to connect with investors and strategic partners – as well as investor groups that collectively manage over US$400 billion in capital – when CEO and managing director Jason Carroll was invited to present at the Biotech Showcase, held on January 15 in San Francisco.
Tryp was selected, along with 400 companies from across the world, to present its recent findings and progress to date.
Financials and operations
The company’s corporate activities during the period included the appointment of BDO Audit Pty Ltd as external auditor and the promotion of chief financial officer Hamish George to Company Secretary, replacing outgoing secretary David Franks.
As at March 31, Tryp held A$4.6 million in cash, up from A$2.8 million in the prior quarter, following the settlement of the second tranche of a previously approved placement.
A further A$0.9 to 1.0 million is expected from the Australian Tax Office as an R&D rebate.
Net operating outflows were reduced to A$1.47 million, as a result of the completion of earlier Phase 1b trials.
The company estimates funding runway for around three quarters and remains focused on expanding its clinical pipeline for TRP-8803 across other neuropsychiatric conditions.
Patient recruitment for the BED trial is set to begin imminently, with high-level results expected by the fourth quarter of calendar year 2025.