Tryptamine Therapeutics advances psychedelic drug candidate TRP-8803 after positive safety review

Tryptamine Therapeutics (ASX: TYP) is preparing to move to the next stage of testing a psychedelic pro-drug compound after receiving positive feedback in the development of its TRP-8803 candidate for the treatment of eating disorders and other conditions.

The Safety Review Council (SRC) response regarding the company’s ongoing Healthy Human Volunteer Study (Phase 1b) has deemed TRP-8803 generally safe and well-tolerated in healthy volunteers at doses that achieve plasma levels of psilocin associated with beneficial effects in various patient populations treated with oral psilocybin.

Psilocybin and psilocin are naturally occurring compounds found in certain mushrooms that are being studied for their therapeutic potential.

Further trials

The company’s chief executive officer Jason Carroll described the results as a major milestone for the company, providing it with the confidence to advance additional Phase 2 clinical trials utilising the innovative and scalable IV infusion of psilocin.

“The safety clearance provided by the SRC on TRP-8803 […] further validates Tryp’s approach to drug development and also serves as a considerable de-risking catalyst moving forward,” Mr Carroll said.

“Work will now focus on finalising results from the Phase 1b study, which will allow the company to gain a broader understanding of the benefits TRP-8803 may provide to patients, refine and optimise the pharmacokinetic profile for the infusion of psilocin to achieve more precise blood levels and take steps to move TRP-8803 into a Phase 2 patient study for its first specific indication.”

Data review

The safety finding for TRP-8803 follows the completion of the company’s Phase 1b study, which was undertaken at CMAX Clinical Research in Adelaide.

The SRC oversight was implemented to review safety data and recommend any necessary modifications to the trial protocol and, in this instance, advise on the dose range of TRP-8803 that appears to have a favourable therapeutic index for use in patient trials.

The study is expected to refine and optimise the dose and infusion rate of TRP-8803 to achieve precise blood levels of psilocin with an acceptable pharmacokinetic profile in participants.

Clinical expansion

Tryptamine will now further develop a proposed clinical trial pathway for TRP-8803.

The company had previously obtained exceptional results from both a Phase 2a study with the University of Florida focused on binge eating disorder that delivered an average reduction in binge episodes of over 80% and a Phase 2a fibromyalgia trial with the University of Michigan that delivered a clinically meaningful reduction in pain, anxiety, brain fog and fatigue in patients.

A new report has identified a 21% increase in the number of people with eating disorders and a 36% increase in economic cost since 2012 in Australia to more than $60,000 per person per year.

It is estimated that around 1.1 million Australians, or 4.5% of the population, are currently living with an eating disorder.