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- Trial against leading antidepressant treatment
- Pre-CTA secured with the University of California
- Escitalopram most widely prescribed antidepressant in the US
- Trial to recruit young adults in the US with MDD
Entropy Neurodynamics (ASX: ENP) has hit a major milestone in the assessment of its Major Depressive Disorder (MDD) treatment candidate with the signing of a pre-clinical trial agreement (pre-CTA) with the University of California, San Francisco (UCSF).
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Under the pre-CTA, phase two clinical trial will compare the company’s proprietary TRP-8803 (IV-infused psilocin) with escitalopram (Lexapro), the most widely prescribed antidepressant in the US.
The trial involving up to 80 young adults with MDD is an important expansion of the clinical development program for TRP-8803.
CEO, Jason Carroll said the trial will help establish a pathway into the US by evaluating the treatment directly against an established antidepressant treatment and the current standard of care in young adults with MDD.
“This is a bold and revolutionary step forward for TRP-8803 and significantly expands the clinical and regulatory pathway we are building around the program,” Mr Carroll said.
“Working with UCSF and Professor Carhart-Harris provides us with the opportunity to evaluate TRP-8803 directly against the most widely prescribed antidepressant in the US and the world, in a patient population where treatment decisions made early in the course of depression can have long-term implications.
“What is particularly compelling about this trial is that we are moving upstream in the treatment pathway. Until now, the development of novel therapies for depression have focused on patients who have already failed years on conventional treatments.
“We want to understand whether a limited number of precision-controlled TRP-8803 treatments can provide an effective alternative treatment in young adults experiencing major depression much earlier in the condition progression.”
Mr Carroll said the trial also has strategic importance beyond MDD.
Subject to FDA clearance, establishing an IND for TRP-8803 would provide Entropy with a US regulatory foundation that could support the broader development of the platform.
“As data emerges from our 72-patient Basket-design Study in Australia, this may support a pathway to advance selected indications into subsequent Phase 2b/3 studies in the US,” he said.
“We’ve been building these pieces very carefully and deliberately over the last 18 months. We now have a broad Australian clinical program underway, a proposed US trial with the world’s leading psychedelic researcher, a pathway towards an IND with the FDA and a manufacturing relationship with BioCina, designed to support TRP-8803 as the program advances.
“Together, these initiatives are intended to generate the clinical evidence required to determine where TRP-8803 may have the greatest therapeutic potential and open the company to commercial partnership discussions.”
Entropy and UCSF will now progress the activities required to develop the proposed Phase 2 trial in the US, including the development and finalisation of the clinical trial protocol and informed consent with UCSF.
The organisations also plan to schedule a pre-IND meeting with FDA to confirm the protocols acceptability; submit an IND application to the US FDA for TRP-8803 for the proposed trial; and following FDA clearance of the trial protocol, finalise the Clinical Trial Research Agreement (CTRA) with UCSF.
ENP was steady at 3.9¢ with a Mkt cap of $63.64M.
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