Entropy’s six-patient BED signal holds as TRP-8803 expands

TRP-8803 BED results remain intact at 12 weeks

Entropy Neurodynamics Limited (ASX:ENP) has carried its strongest clinical signal into a second checkpoint, reporting that all six patients in Cohort 1 of its Phase 2 treatment-resistant binge eating disorder study retained clinically meaningful improvement 12 weeks after receiving TRP-8803, its intravenous psilocin formulation. Half the cohort remained in clinical remission, while weekly binge-eating episodes were 73% below pre-treatment levels, broadly maintaining the 74% reduction recorded after four weeks.

The durability data, drawn from a small six-patient cohort, give the company an early basis for testing whether two infusions can produce sustained benefit. Three patients reported no binge-eating episodes during the full 84-day follow-up, while measures of anxiety, depression, life satisfaction and overall clinical impression also remained improved at 12 weeks. The company had previously reported the initial BED response in its six-patient BED cohort, but the size of the dataset remains an important qualification to the result.

Shorter infusion protocol becomes the next clinical test

After a favourable safety and tolerability review, Cohort 2 has begun testing whether the infusion period can be cut from 140 minutes to 60 minutes. The first patient completed the shortened protocol safely and recorded peak psychedelic intensity of 9/10, although that single observation is not evidence yet that the shorter regimen will reproduce Cohort 1’s efficacy or tolerability profile. Cohort 2 is fully recruited, with topline results expected by the end of calendar 2026.

That timetable gives Entropy a near-term test of the practical proposition behind TRP-8803: that faster onset, predictable intensity and a controlled treatment duration could make psychedelic-assisted therapy easier to deliver in clinical settings. The company presented data from 12 dosing sessions at the European College of Neuropsychopharmacology Congress, reporting no serious adverse events or treatment discontinuations, but the evidence remains early-stage and limited to six patients.

Eight-indication study broadens the development program

Entropy has also secured Human Research Ethics Committee approval for a Phase 1b/2a basket study covering up to 72 patients across eight indications: anorexia nervosa, body dysmorphic disorder, obsessive compulsive disorder, generalised anxiety disorder, post-traumatic stress disorder, treatment-resistant depression, fibromyalgia and irritable bowel syndrome. Treatment-resistant depression will be split between patients taking antidepressants and those who are not, giving the company two separate cohorts within the program.

The study marks a shift from building TRP-8803 around BED alone to screening several potential indications under one clinical framework. Entropy’s earlier 72-patient basket study had already established the multi-indication direction; the new quarter’s update adds the ethics approval and a further Clinical Trial Research Agreement with Swinburne University of Technology. Results will be used to inform which disorders receive greater development attention, rather than establishing that the therapy will work across all eight.

US trial pathway and manufacturing base take shape

A pre-Clinical Trial Agreement with the University of California, San Francisco has created a proposed US Phase 2 pathway for major depressive disorder. The planned study would compare TRP-8803 with escitalopram in up to 80 young adults, assess depression severity over eight weeks and six months, and be led by Professor Robin Carhart-Harris. The trial remains subject to protocol development, FDA acceptance of an Investigational New Drug application and other preparations, with commencement targeted for the first half of calendar 2027.

Entropy has paired that clinical expansion with a Development and Manufacturing Services Agreement with BioCina covering analytical verification, engineering batches and GMP production of active TRP-8803 and placebo. The arrangement is intended to generate pharmaceutical and stability data for future regulatory submissions, while the company retains ownership of its TRP-8803 intellectual property. That GMP manufacturing agreement gives the manufacturing work a clearer role in supporting international trials, rather than leaving it as a standalone supply announcement.

Cash position leaves limited room for execution

Entropy ended September with $3.626 million in cash and an undrawn $2.6 million R&D loan facility, giving total available funding of $6.225 million. Net operating cash outflow was $1.819 million for the quarter, up from $1.4 million in the June quarter, and the Appendix 4C calculates approximately 3.4 quarters of funding at that rate. The company also expects a $2 million R&D Tax Incentive refund in the current quarter, but that expected receipt is not included in the 3.4-quarter calculation.

The next readout is therefore unusually important for a company advancing several programs at once. Cohort 2 must show whether a 60-minute infusion can preserve the clinical and operational characteristics that underpin TRP-8803’s commercial case, while the basket study, UCSF regulatory work and GMP program will all compete for capital before larger trials can provide more decisive evidence.