Enveric Biosciences has made advancements with its drug discovery and development progress targeting mental health indications and intellectual property (IP).
Enveric Biosciences has been advancing its drug discovery and development progress.
Based on extensive direct clinical understanding of the current unmet needs in anxiety, depression, PTSD and other mental health indications, coupled with in-depth knowledge of the current treatment landscape, Enveric has stated that its clinical team is well positioned to tackle the challenges ahead, while aiming to shepherd novel new treatments for a host of mental health indications.
Enveric CEO, Dr Joseph Tucker, PhD, commented: “The first half of 2022 was foundationally successful for Enveric. We validated and executed on the corporate premise that we can deploy PsyAITM, our proprietary artificial intelligence tool, and PsybraryTM, our expanding proprietary portfolio of new chemical entities and drug candidates, to design and improve upon new drug molecules inspired by legacy psychedelic drugs.
“Enveric is pleased to advise that our predictions have materialised, and our platforms have successfully generated a large number of promising new molecules that have successfully passed primary screening and moved on to lead optimisation, providing us with a strong slate of drug candidates.
“Our leading program, EVM-201, includes a number of new molecules currently in lead optimization that are geared towards providing improved characteristics and drug-like properties compared with psilocybin.
“The successful outcomes from our testing efforts completed in the first half of 2022 have positioned the company very well to advance our drug candidates towards the clinic.”
Enveric’s Clinical Team is led by a past Board-certified psychiatrist and clinical trialist Chief Medical Officer, Dr Bob Dagher, MD.
Dr Dagher joined Enveric in December 2021, bringing a wealth of clinical trial management and new CNS-drug development experience from his past roles, including at WCG, Cadent, Covance, Sanofi and GSK, in addition to his first-hand experience in treating patients from his previous clinical practice in psychiatric medicine.
Next-generation drug discovery
Enveric’s Discovery Team, spearheaded by Chief Innovation Officer Dr Peter Facchini, PhD, an international leader in natural product biochemistry and biotechnology, completed the rational design of more than 300 Generation-2 (Gen-2) psilocin prodrug candidates using well-established design strategies, but adapted to the unique structure of psilocin.
The 300 Gen-2 original concept designs, now housed within the PsybraryTM, were screened using PsyAITM. The assessment helped predict chemical structures with appropriate receptor binding, toxicology, and pharmacokinetic profiles that would trigger the desired mechanisms of action while reducing undesirable side effects, and the initial candidate evaluation included, among other metrics, prodrug-likeness, toxicity, ease of chemical synthesis and degree of IP-white space surrounding the molecule.
Ranked scoring of these and other AI assessments, as well as commercial considerations (e.g., ease of procuring synthetic starting materials), prioritized 31 novel Gen-2 molecules that have been synthesized in sufficient quantities (~10 mg, 95 per cent purity) for preliminary pharmacological screening.
Enveric’s Chemistry Group, led by Dr Kaveh Matinkhoo, PhD, completed these syntheses, 29 of which were deemed stable enough to advance.
Deep-dive chemical structure searches, patentability, and freedom-to-operate reviews were performed on all 29 candidates, under the leadership of Lead Internal Counsel C. Michael Gegenheimer.
The company has stated that all the patentability analyses indicated potential patentability results, and 25 of the 29 molecules presented minimal concern with freedom to operate. To strengthen the IP protection for the overall Gen-2 prodrug program, three provisional patent applications, covering seven structurally diverse clinical classes and thousands of additional potential new drug candidates, have been filed so far in 2022, and additional provisional and PCT filings are expected to continue throughout the year.
In other IP developments, an additional three of Enveric’s international patent applications protecting tryptamine derivatives have been published by the World Intellectual Property Organization, bringing the total published so far to seven.
EVM-201 drug candidate testing
Following the initial Gen-2 ideation, patent filing, synthesis, and screening efforts, more extensive assays were performed on the advancing drug candidates.
Numerous internal assays were performed under the leadership of Dr Jill Hagel, PhD, Vice-President of Innovation and Dr Sheetal Raithatha, PhD, Director of Research and Development.
The internal results were then confirmed and validated using leading independent, third-party Contract Research Organisations (CROs), covering 122 Toxicology tests, 72 receptor-binding and potency tests, 31 pharmacokinetic tests and 24 animal-model tests to provide ample information to support candidate nomination.
The synthesis and analysis of these comprehensive pharmacology and toxicology datasets, both internal and external, was led by Dr Kevin Leach, PhD DABT, Vice President of Preclinical and Translational Research.
The company is now moving towards lead-candidate nomination and, in preparation for IND filing, has initiated numerous IND-enabling studies on several of the leading candidates at third-party CROs.
Recognising the need for stable drugs with robust, reproducible, and cost-effective manufacturing, several Contract Development & Manufacturing Organizations (CDMOs) are currently engaged with Enveric’s Chemistry Team to determine how best to manufacture its molecules.
Enveric also has plans in place to produce material at commercial facilities and the CDMO personnel have worked with its chemists to validate that our processes will work at their facilities. This is another necessary step prior to filing the IND. Preliminary formulation work is underway, with a particular focus on enabling improved routes of administration.
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