Enveric Biosciences has signed an agreement with Australian contract research organisation (CRO) Avance Clinical, for the planned Phase I clinical trial of EB-373 to treat anxiety disorders.

Under the terms of the deal, Avance Clinical will be responsible for managing the trial in coordination with Enveric Therapeutics, Enveric Biosciences’ newly established Australian subsidiary.

The dose-ascending, multi-cohort clinical trial is expected to commence in the fourth quarter of this year, and has been designed for measuring the tolerability and safety of the company’s lead candidate, EB-373.

The next-generation psilocin prodrug EB-373 has been developed using the Psybrary drug discovery platform of Enveric Biosciences to target anxiety disorders. It was found to effectively interact with different serotonin receptor types, including the serotonin 5-HT2A receptor, in preclinical studies.

The Therapeutic Goods Administration (TGA) of Australia has recognised EB-373, which is currently in the preclinical development, as a New Chemical Entity (NCE).

Enveric Bioscience director and CEO Joseph Tucker said: “With our Australia subsidiary established, we are actively preparing to initiate the planned Phase I trial of EB-373 and are pleased to have Avance Clinical as our CRO partner, given the company’s proven expertise and experience managing early-stage clinical programmes in Australia.

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“EB-373 has the potential to bring much-needed innovation to the treatment of anxiety disorder, which is underserved by current therapeutic options.

“We are eager to evaluate the potential of EB-373 in this first-in-human Phase I clinical trial as an initial step towards building a broader pipeline of proprietary psilocin prodrugs and other innovative, psychedelic-inspired compounds for a range of mental health conditions.”