Entropy Neurodynamics Appoints BioCina for Global Manufacture of TRP-8803 IV Psilocin

Clinical-stage biotechnology company Entropy Neurodynamics (ASX: ENP) has appointed global contract development and manufacturing organisation BioCina to produce its proprietary TRP-8803 intravenous psilocin formulation for international markets.

The appointment establishes the pharmaceutical manufacturing capabilities required to support the ongoing development of TRP-8803 as it progresses beyond current clinical activities towards broader regulatory and commercial opportunities.

Under the terms of the agreement, BioCina will manufacture placebo and active drug product batches at its Perth facility using its Cytiva SA25 robotic aseptic filling line to bottle TRP-8803 into sterile 10 millilitre glass vials.

Pharmaceutical and stability data generated from the program will form a core component of Entropy’s regulatory submissions in the US, Europe, and other major markets.

Manufacturing is expected to take six months followed by two years of real-time stability studies.

Oral Psilocybin Alternative

TRP-8803 has been designed to overcome the variability and unpredictability of oral psilocybin, enabling consistent therapeutic exposure and offering precise control over the onset, intensity, and duration of the psychedelic experience.

It delivers psilocin directly into the bloodstream, avoiding gastrointestinal absorption and conversion from psilocybin while allowing clinicians to control treatment intensity and pause or terminate an infusion if required.

Entropy is currently advancing TRP-8803 through a 72-patient study across eight neuropsychiatric indications of high-unmet clinical need including treatment-resistant major depressive disorder, anorexia nervosa, body dysmorphia, obsessive compulsive disorder, generalised anxiety, post-traumatic stress, fibromyalgia, and irritable bowel syndrome.

Each patient will receive two doses of the drug approximately two weeks apart alongside a structured psychedelic-assisted psychotherapy program.

Recruitment is due to begin shortly, with dosing in one or more indication cohorts occurring before year end.

Critical Strategy Component

Entropy chief executive officer Jason Carroll said a robust and scalable manufacturing process was a critical component of the company’s trial and commercialisation strategy.

“Our agreement with BioCina is an important strategic step in building the infrastructure required to realise the broader potential of TRP-8803,” he said.

“We are generating an expanding body of clinical evidence around our precision-controlled intravenous approach to psychedelic therapy and it is important that we build a pharmaceutical manufacturing engine alongside it, capable of rapid scale-up, global distribution and commercial-grade consistency.”

“With scalable GMP manufacturing now secured, Entropy is positioned to advance TRP-8803 as a globally relevant therapeutic platform across multiple indications, multiple geographies, and with multiple regulatory pathways.”