Entropy Neurodynamics (ASX:ENP) has announced progress in the clinical development of TRP-8803 after an independent Data Safety Monitoring Board (DSMB) completed its review of Cohort 1 safety data and recommended the trial proceed to Cohort 2 without any changes to the protocol.
The Phase 2 study is testing TRP-8803, an intravenous psilocin formulation, in 12 patients divided into two cohorts of six, each receiving two administrations 14 days apart alongside supportive therapy.
The DSMB review confirmed a favourable safety and tolerability profile across all six participants in Cohort 1. No serious adverse reactions and no suspected unexpected serious adverse reactions were reported. All participants completed both dosing sessions, and there were no discontinuations due to safety events. Most adverse reactions were assessed as mild or moderate, and one Grade 3 event was observed and managed in accordance with protocol.
Based on the Cohort 1 data, the DSMB recommended that Cohort 2 proceed under the protocol-specified 60-minute infusion regimen. Cohort 1 used a 20-minute loading dose followed by a 120-minute maintenance dose for a total of 140 minutes. The DSMB selected a 60-minute option for Cohort 2, consisting of a 20-minute loading dose followed by a 40-minute maintenance dose to further characterise safety, feasibility, and pharmacokinetics at a clinically relevant infusion duration. Cohort 2 has been fully recruited and is ready to commence dosing, with completion expected in the third quarter of calendar year 2026. Topline results are anticipated in late 2026.
Entropy CEO Jason Carroll said, “The DSMB’s recommendation to progress to Cohort 2 without any protocol changes is an important milestone for the TRP-8803 program and provides independent validation of the favourable safety profile observed in Cohort 1.”
He added, “The DSMB’s endorsement of the planned 60-minute infusion regimen is particularly encouraging, reflecting confidence in both the tolerability and operational feasibility of the approach. With Cohort 2 fully recruited, we are well positioned to continue advancing this promising program.”