Enveric Biosciences, a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, established Enveric Therapeutics Pty. Ltd., an Australia-based subsidiary, to support the company’s plans to advance its EVM201 Series, including lead candidate EB-373, towards the clinic.

Enveric Therapeutics will oversee the company’s preclinical, clinical, and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the Therapeutic Goods Administration (TGA), Australia’s regulatory authority.

Enveric’s lead drug candidate, EB-373, is a next-generation synthetic New Chemical Entity (NCE) designed as a psilocin prodrug and developed leveraging its Psybrary drug discovery platform. Enveric expects to initiate a Phase 1 first-in-human clinical trial investigating EB-373 targeting anxiety disorders in the fourth quarter of 2023.

“Australia is an ideal location to advance the development of EB-373, as well as additional future therapies generated from our EVM201 and EVM301 Series, given the favorable clinical, regulatory and cost-saving opportunities available to biotechnology companies, particularly those advancing psychedelic-derived compounds for CNS conditions,” said Joseph Tucker, director and CEO of Enveric Biosciences. “With the establishment of Enveric Therapeutics Pty. Ltd., we now have a foothold in Australia that we expect will enable us to efficiently and expeditiously advance our lead program towards generating human data by early 2024.”

According to the company, Australia has enacted several policies designed to enable more efficient and cost-effective early-stage product development. Clinical trials conducted under the Clinical Trial Notification (CTN) Scheme or Clinical Trial Exemption (CTX) Scheme – the two pathways endorsed by the TGA for administering clinical trials in Australia – do not require an active Investigational New Drug (IND) application to proceed.

In addition, The Australian Government’s Research and Development Tax Incentive provides a 43.5 percent rebate for every dollar spent on R&D. Additionally, Australian regulators have recently advanced guidance intended to encourage the development of psychedelic-derived prescription therapeutics.

“Research conducted in Australia offers high quality and scientific rigor by leveraging strong local expertise and regulatory policies designed to encourage innovation. This forward-thinking approach has made the country an attractive option for conducting early preclinical and clinical programs and advancing psychedelic-inspired new therapeutics,” said Bob Dagher, chief medical officer of Enveric Biosciences. “Given this, we are eager to initiate our clinical development program of EB-373 in Australia and look forward to benefiting from the country’s high-quality clinical research sites.”