Enveric Creates Subsidiary Down Under To Further Next-Generation Psychedelics Program

Drug development biotech company Enveric Biosciences ENVB has created Australia-based subsidiary Enveric Therapeutics Pty. Ltd. to support the progress of its next-generation psychedelics program for anxiety disorders, EVM201, towards the clinical stage.

The series includes lead candidate EB-373, a synthetic New Chemical Entity (NCE) designed as a psilocin prodrug, developed using the company’s drug discovery platform Psybrary and which provided positive preclinical results in animal behavioral models of anxiety. 

The new subsidiary will oversee Enveric’s preclinical, clinical and regulatory activities in Australia, including ongoing interactions with the local Human Research Ethics Committees (HREC) and the federal Therapeutic Goods Administration (TGA), with hopes of beginning a Phase 1 first-in-human trial on EB-373 in Q4 2023.

Why Australia?

Several companies are expanding their businesses in the Aussie landscape, as recent regulations have laid the ground for psychedelic-friendly activities. 

See also: Incannex Healthcare Prepares To Launch Psychedelics Clinics Via New Subsidiary

Enveric’s CEO and a speaker at the upcoming Benzinga Psychedelics Capital Conference (see below) Dr. Joseph Tucker, Ph.D., says that the country is “an ideal location” to advance the development of both the company’s lead drug candidate and additional future therapies generated from its next-gen compound series given the “favorable clinical, regulatory and cost-saving opportunities” available to biotechnology companies, and particularly to those advancing psychedelic-derived compounds for CNS conditions. 

“With the establishment of Enveric Therapeutics, 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,” Tucker said.

CMO Dr. Bob Dagher added that Australia-based research 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,” Dagher said.

Australia’s policies towards enabling more efficient and cost-effective early-stage product development include clinical trials conducted under the Clinical Trial Notification (CTN) or clinical trial exemption (CTX) schemes, which do not require an active Investigational New Drug (IND) application to proceed, plus a federal R&D tax incentive of a 43.5% rebate for every dollar spent.

Benzinga’s PCC

The second edition of the Benzinga Psychedelics Capital Conference is coming your way! 

The event will take place at the Fontainebleau Miami Beach Hotel in Florida on April 13, 2023. This is THE place to get DEALS DONE, raise money, jumpstart M&A and meet investors and key partners including Dr. Tucker. 

Get your tickets now before prices go up.

Photo by Srikant Sahoo on Unsplash