Tryptamine cleared for BED trial supply
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.
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