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Pharma & Biotech

Tryptamine Therapeutics strengthens clinical development team

Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has further strengthened its TRP-8803 clinical development team, with the appointments of Professor Marcel Mozafari as senior formulation scientist, and Professor David Castle as consultant medical officer.

The pair is set to significantly bolster Tryp's clinical development efforts, particularly in anticipation of the world-first trial of their lead drug candidate, TRP-8803, for the treatment of Binge Eating Disorder in collaboration with Swinburne University.

Both Professor Mozafari and Professor Castle are Australian-based, which is expected to streamline operational structures and potentially leverage R&D tax rebates for more cost-effective research.

“We are pleased to confirm the respective appointments of Marcel and David to our clinical development team. The appointment of two exceptional team members come at a crucial time and are in line with Tryp’s strategy to grow its operations team commensurate with the anticipated expansion of our clinical program for TRP-8803. Importantly, both are based in Australia which will provide a streamlined operational structure, as well as the potential to further leverage R&D tax rebates for more cost-effective research,” Tryp CEO, Jason Carroll, said.

“Activity is ramping up for our world-first trial, in collaboration with Swinburne University, to assess the safety and efficacy of TRP-8803, alongside psychotherapy, in treating Binge Eating Disorder. We expect to provide regular updates on clinical progress throughout the next two quarters as we continue to advance the treatment pathway for this novel treatment solution.”

Professor Marcel Mozafari

Professor Marcel Mozafari joins Tryptamine Therapeutics as a senior formulation scientist in a full-time capacity. He is a highly credentialed scientist with 25 years of specialised expertise in pharmaceutical nanotechnology and direct experience in drug development and clinical trial programs.

Professor Mozafari was also the president and founder of the Australasian Nanoscience and Nanotechnology Initiative. Throughout his career, he has successfully guided numerous scientific projects from the research phase to commercialisation, serving as both a Formulation Scientist and Head of R&D. His extensive academic contributions include over 200 scientific publications, notably a March 2019 paper in Pharmaceutics that became the most cited paper in the journal's history with over 3,600 citations. His expertise is expected to be invaluable for the ongoing clinical development of TRP-8803 (IV-infused psilocin).

Professor David Castle

Professor David Castle has been appointed as a consultant medical officer on a permanent, part-time basis, adding valuable operational insight to Tryp's clinical trial program.

Professor Castle is one of Australia's most distinguished psychiatrists and a member of Tryp's Scientific Advisory Board, appointed in July 2024 for a three-year term. He currently serves as Professor of Psychiatry at the University of Tasmania's Centre for Mental Health Service Innovation. Previously, he held the position of Professor of Psychiatry at the University of Melbourne from 2006 to 2021.

Professor Castle has a specific research interest in the application of psychedelic therapies to achieve improved health outcomes and is one of Australia's most published researchers in mental health, with over 900 journal articles. He is also a lead clinician for multiple ongoing clinical studies using oral psilocybin in Australia and Canada.

TRP-8803 clinical development and company vision

Tryptamine Therapeutics is a clinical-stage biotechnology company focused on developing novel formulations of psilocin in combination with psychotherapy to address unmet medical needs.

Their lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin, designed to mitigate limitations of oral psilocybin by reducing onset time, controlling psychedelic experience depth and duration, and shortening intervention time to a commercially viable timeframe.

The company has completed a Phase 2a clinical trial for Binge Eating Disorder at the University of Florida, demonstrating an average reduction in binge eating episodes of over 80%.

Tryp has also completed a Phase 2a trial for fibromyalgia in collaboration with the University of Michigan and initiated a Phase 2a trial with Massachusetts General Hospital for irritable bowel syndrome.

These studies are currently using TRP-8802 (synthetic, oral psilocybin), with subsequent studies expected to transition to TRP-8803 for potentially improved efficacy, safety and patient experience.

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