Enveric Biosciences has confirmed it has completed the manufacture of its lead drug candidate – EB-373 – a New Chemical Entity (NCE) designed as a next-generation proprietary psilocin prodrug.
Now manufacturing of EB-373 is complete, the company expects to complete all remaining preclinical studies required for Human Research Ethics Committee (HREC) submission in Australia before year-end 2023.
HREC Australia reviews research proposals that involve human participants to ensure that they meet ethical standards and guidelines.
In February, Australia updated its laws on access to psychedelic treatments in the country. Under the new classification, the substances will change from Schedule 9 which is prohibited substances, to Schedule 8, which is controlled drugs, of the Poisons Standard, with authorised psychiatrists now able to prescribe MDMA and psilocybin for PTSD and treatment-resistant depression, respectively, from 1 July.
Joseph Tucker, Ph.D., Director and CEO of Enveric commented: “We are excited to highlight the extremely high-quality formulation and manufacturing work of our team and partners as we take the final steps required to bring EB-373 into initial clinical trials.
“By eliminating the restrictive requirements of handling and shipping controlled substances, our research teams and partners will be able to work more efficiently, saving Enveric time and costs both now and in our future clinical trials.”
According to the company, in preclinical studies, EB-373 has so far displayed efficient prodrug parameters, demonstrating rapid and complete generation of psilocin both in vitro and when orally administered.
Mice treated with EB-373 demonstrate dose-dependent induction of head twitch response characteristic of psilocin. In the Marble Burying Test, an animal behavioral model of anxiety, EB-373 was able to rescue the enhanced rate of marble burying observed in chronically stressed mice, in line with the control baseline behaviour and with long-term anxiolytic benefits lasting the length of the study, seven days post-dose.
Preclinical work for EB-373 will includes all bioanalytical method validation, GLP toxicology and GLP safety pharmacology studies and the company will now commence remaining GLP studies to provide critical data required to initiate human trials for EB-373.
Enveric worked with a contract development and manufacturing organization (CDMO) partner to optimise and scale up the manufacturing process for EB-373, successfully producing sub-kilogram amounts of the EB-373 salt form with 99% purity.
The company has stated that, with the high purity of EB-373 manufactured drug product, it measured no controlled impurities within the analytical limit of quantitation, meaning Enveric and its research partners will be able to handle and ship EB-373 without restrictive limitations required for controlled substances.
