Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a neuroscience-focused biotechnology company developing next-generation psychedelic-inspired mental health drugs, today disclosed advances in drug discovery and development targeting mental health indications and advances in intellectual property (IP) achieved in the first half of 2022.

“The first half of 2022 has been fundamentally successful for Enveric. We validated and executed on the principle of the company that we can deploy PsyAIMTour proprietary artificial intelligence tool, and PsybraryMTour expanding proprietary portfolio of new chemical entities and drug candidates, to design and improve new drug molecules inspired by legacy psychedelic drugs,” said Dr. Joseph Tucker, PhD, CEO of Enveric.

“Enveric is pleased to report that our predictions have come to fruition and that our platforms have successfully generated a large number of promising new molecules that have successfully passed primary screening and moved on to lead optimization, providing us with a strong list of drug candidates. Our lead program, EVM-201, includes a number of novel lead molecules currently being optimized that aim to provide enhanced characteristics and drug-like properties over psilocybin. The positive results from our testing efforts completed in the first half of 2022 have positioned the company very well to advance our drug candidates to the clinic,” continued Dr. Tucker.

Focused on clinical needs

Based on an in-depth direct clinical understanding of current unmet needs for anxiety, depression, PTSD and other mental health indications, combined with an in-depth knowledge of the current treatment landscape, the clinical team d’Enveric is well positioned to meet the challenges ahead, while aiming to pilot new treatments for a host of mental health indications.

Enveric’s clinical team is led by former board-certified psychiatrist and Chief Clinical Trials Physician, 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 WCG, Cadent, Covance, Sanofi and GSK, in addition to his first-hand experience in treating patients from his previous clinical practice in psychiatric medicine.

Discovery of next-generation drugs

Enveric’s discovery team, led by Chief Innovation Officer Dr. Peter Facchini, PhD, an international leader in natural product biochemistry and biotechnology, has completed the rational design of more than 300 prodrug candidates of generation 2 (“Gen-2”) psilocin using well-established design strategies, but adapted to the unique structure of psilocin.

The original 300 Gen-2 designs, now housed in the PsybraryMTwere screened using PsyAIMT. The assessment predicted chemical structures with appropriate receptor binding, toxicology, and pharmacokinetic profiles that would elicit the desired mechanisms of action while reducing unwanted side effects, and the candidate’s initial assessment included, among other measures include prodrug-likeness, toxicity, ease of chemical synthesis, and degree of IP-white space surrounding the molecule.

Ranked scoring from these and other AI assessments, along with commercial considerations (e.g., ease of sourcing synthetic raw materials), prioritized 31 novel Gen-2 molecules that were synthesized in sufficient quantities (~10 mg, 95% purity) for preliminary pharmacological screening. Enveric’s chemistry group, led by Dr. Kaveh Matinkhoo, PhD, performed these syntheses, 29 of which were deemed stable enough to move forward.

Extensive chemical structure, patentability, and freedom-to-operate reviews were performed on the 29 applicants, under the direction of senior in-house counsel C. Michael Gegenheimer. All patentability analyzes indicated potential patentability outcomes, and 25 of the 29 molecules had minimal freedom-to-operate concerns.

To strengthen intellectual property protection for the entire Gen-2 prodrug program, three provisional patent applications, covering 7 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. continue throughout the year.

In other intellectual property developments, Enveric’s three other international patent applications protecting tryptamine derivatives have been published by the World Intellectual Property Organization, bringing the total published to date to seven.

Test of the drug candidate EVM-201

Following the initial Gen-2 ideation, patent filing, synthesis and screening efforts, more extensive testing has been performed on the advancing drug candidates. Extensive internal testing was conducted under the direction of Dr. Jill Hagel, PhD, Vice President of Innovation and Dr. Sheetal Raithatha, PhD, Director of Research and Development. The in-house results were then confirmed and validated using leading independent third-party Contract Research Organizations (CROs), covering 122 toxicology tests, 72 receptor binding and potency tests, 31 pharmacokinetic tests and 24 animal model tests to provide ample supporting information. nomination of candidates.

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. Enveric is now moving towards lead candidate nomination and, in preparation for the IND filing, has initiated numerous IND-enabling studies on several of the lead candidates at third-party CROs.

Recognizing the need for stable drugs with robust, reproducible, and cost-effective manufacturing, several contract development and manufacturing organizations (CDMOs) are currently working with Enveric’s chemistry team to determine the best way to manufacture our molecules. Enveric has plans in place to produce material in commercial facilities and CDMO staff have worked with our chemists to validate that our processes will work in their facilities. This is another necessary step before filing the IND. Finally, preliminary formulation work is in progress, with particular emphasis on improving the routes of administration.

“The first half of the year has indeed been a busy and productive one for Enveric’s dedicated team. We are all delighted to see how these efforts have started to bear fruit. We look forward to updating our shareholders on other key developments, which we believe will continue through the remainder of 2022,” Dr. Tucker concluded.

About Enveric Biosciences

Enveric Biosciences, Inc. (NASDAQ: ENVB) is a neuroscience-driven pharmaceutical company developing next-generation psychedelic-inspired mental health drugs. Enveric’s robust pipeline supports clinical-to-market drug development aimed at helping millions of needy patients around the world suffering from conditions such as cancer-related distress, PTSD and more. For more information, please visit www.enveric.com.

Forward-looking statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as “anticipates”, “expects” or “does not expect”, “proposed”, “is planned », « budget », « planned ». “, “estimates”, “plans”, “intends”, “anticipates” or “does not anticipate” or “believes”, or variations of these words and expressions, or by the use of words or of expressions indicating that certain actions, events or results can, might, might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including statements regarding beliefs, plans, expectations or intentions regarding the future. These forward-looking statements are based on management’s beliefs as well as assumptions made by management and information currently available to it. Actual results could differ materially from those contemplated by the forward-looking statements due to certain factors, including, but not limited to, the Company’s ability to successfully dispose of its cannabinoid assets; the ability to achieve the value creation envisaged by the technical developments; the impact of the novel coronavirus (COVID-19) on ongoing and planned clinical trials of Enveric; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct business and raise capital in the future should the need arise; delays in planned clinical trials; the ability to establish that potential products are effective or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to commercialize potential products; the ability to obtain future financing for development products and working capital and to obtain such financing on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaboration with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to obtain and enforce legal rights relating to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties regarding Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including the company’s Annual Report on Form 10. -K and its quarterly reports on Form 10 -Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

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