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Enveric Biosciences Receives Notice of Allowance for New Class of Low-Hallucinogenic Neuroplastogens Targeting Psychiatric Disorders

Enveric Biosciences Receives Notice of Allowance for New Class of Low-Hallucinogenic Neuroplastogens Targeting Psychiatric Disorders

National Post10-06-2025
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Patent-protected aminated tryptamine derivatives strengthen Enveric's leadership in next-generation mental health treatments
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CAMBRIDGE, Mass. — Enveric Biosciences (NASDAQ: ENVB) ('Enveric' or the 'Company'), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application covering compositions of matter and methods of use for a novel class of aminated tryptamine derivatives.
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The patented compounds were designed through Enveric's proprietary discovery platform and represent a first-in-class approach to non-hallucinogenic psychedelic-inspired therapeutics. The compounds demonstrated low hallucinogenic liability in preclinical testing, including minimal Head Twitch Response (HTR) and reduced 5-HT2A receptor activation – two established indicators of hallucinogenic activity in rodents.
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'The allowance of this application adds a new tier of patent-protected innovation to our pipeline of non-hallucinogenic neuroplastogens,' said Joseph Tucker, Ph.D., CEO of Enveric. 'Unlike traditional psychedelics that require intensive clinical monitoring due to their hallucinogenic effects, our molecules are designed for frequent, flexible, outpatient dosing, which we expect will be better aligned with patient lifestyles, clinics workflows, and payers established models.'
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Non-hallucinogenic psychedelic analogs represent a critical evolution in the treatment of psychiatric and neurological disorders, with potential to treat conditions like depression, anxiety, PTSD, and cognitive impairment, without the operational limitations of hallucinatory experiences. The patent covers both the molecular compositions and their therapeutic applications, further strengthening Enveric's competitive position in this emerging category.
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'This achievement reflects Enveric's continued execution on its mission to develop safe and effective neuroplastogenic therapeutics,' Dr. Tucker added. 'Each addition to our intellectual property portfolio helps build a more valuable portfolio of assets for long-term growth.'
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The patented molecules were discovered through the Company's proprietary discovery and development platform, which leverages computational and medicinal chemistry to identify optimized, next-generation therapeutic molecules with favorable safety, pharmacology, and scalability profiles.
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About Enveric Biosciences
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Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric's lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.
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Forward-Looking Statements
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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 may be identified by the use of forward-looking terminology such as 'plans,' 'expects' or 'does not expect,' 'proposes,' 'budgets,' 'explores,' 'schedules,' 'seeks,' 'estimates,' 'forecasts,' 'intends,' 'anticipates' or 'does not anticipate,' or 'believes,' or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric's products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.
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A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission, including Enveric'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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New data obtained by CTV News from Health Canada shows that 85 per cent of inspections of drug manufacturing sites supplying the Canadian market were conducted by international regulators—not Health Canada. (Guteksk7 / Getty Images) Drug manufacturers are tasked with formulating and producing the medications millions of Canadians take each day, from antibiotics to blood pressure medications. We trust them to stick to strict standards — because quality issues can compromise treatments, worsen health outcomes, and in the most severe cases, make patients seriously ill. New data obtained by CTV News from Health Canada shows that 85 per cent of inspections of drug manufacturing sites supplying the Canadian market were conducted by international regulators — not Health Canada. Given the scale and complexity of the global pharmaceutical supply chain for both brand name and generic drugs, reliance on partners is necessary. But the United States, which Canada relies on for 70 per cent of these inspections, has been facing an inspection backlog and remains behind its pre-pandemic inspection levels. Experts are raising concerns about how well the system can safeguard Canadians from substandard or dangerous medications. US FDA logo A U.S. Food and Drug Administration building is seen behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md., on Aug. 2, 2018. (AP Photo/Jacquelyn Martin, File) David Ridley is a health economist at Duke University in North Carolina who has studied the U.S. Food and Drug Administration (FDA) drug manufacturer inspection system in the United States. He said recent cuts to the regulator as part of the Department of Government Efficiency (DOGE) 'are disruptive and very stressful for FDA staff, but the problems with inspections date back for years, even decades.' 'Many of these establishments are not being inspected by Canadian or U.S. officials,' said Ridley. 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'I worry that people will start to cut corners,' said Herder. Past failures reveal the stakes The drugs Canadians take are manufactured around the world. In 2024, 30.8 per cent of Canada's pharmaceutical imports originated from the United States, at least 33.5 per cent from European countries, 3.2 per cent from India, and 2.9 per cent from China — according to trade data from Statistics Canada. Over the years the industry has been dogged with a series of safety lapses. In 2023, eye drops manufactured in India were recalled after contamination with drug resistant bacteria was discovered. The products were traced to three deaths and eight cases of blindness in the United States, according to the New York Times. Eye drops A selection of eye drops line a shelf at a pharmacy in Los Angeles on Dec. 12, 2023. Repeated recalls of eyedrops were drawing new attention to the limited powers U.S. regulators have to oversee medical products made overseas. Unlike prescription drugs, eyedrops and other over-the-counter products don't get preliminary review by the FDA. (AP Photo/Richard Vogel) The FDA reported more than 100 people died after taking a common blood thinner that was recalled in 2007 due to contamination with an unnatural chemical during manufacturing in China. Reporter Katherine Eban's 2019 book Bottle of Lies chronicled profit-motivated fraud and deceit at Indian generic pharmaceutical company Ranbaxy in a decade-long investigation. In recent years in Canada, drugs have been recalled for manufacturing issues like microbial and latex contamination. Mina Tadrous, the Canada research chair in real-world evidence and pharmaceutical policy and an associate professor at University of Toronto, estimates that the 2018 recall of valsartan for nitrosamine impurities (considered probable human carcinogens) led 200,000 patients to switch prescriptions in a single month in Canada. The recall rippled through the health care system causing disruptions for patients, doctors and pharmacists. While toxic contamination is a worst-case scenario, the most common impact is more insidious, said Ridley. 'If the product is low quality, the most likely outcome is it's just not going to be as effective. And that's going to be really hard for people to notice.' Ineffective prescription drugs can lead to failed treatments, prolonged illness, drug resistance, and a loss of trust in healthcare. 'Pharmacists count on a strong regulatory system to make sure medications are safe and high-quality,' said Tyler Gogo, senior manager of communications at the Canadian Pharmacists Association in an emailed statement. He said when that system falls short, 'it can cause real problems in delivering care.' Reliance on foreign regulators As of March 31, 2025, Canada's drug supply relied on 927 facilities within the country and 5,024 located abroad. Last fiscal year, Health Canada conducted 312 domestic onsite inspections, 47 foreign onsite inspections and relied on information from trusted international regulatory partners like the FDA, for another 2086 site inspections. Like the United States, Canada halted international inspections in 2020 due to pandemic-related travel restrictions. While the inspections resumed, they did not increase to make up for the missed year. However, Health Canada said it does not have any backlogs for planned inspections. 'That's the strength of the reliance model,' said Kim Godard, Director General, Health Product Compliance Directorate at Health Canada, 'everyone kind of pitches in, we're not in the same situation in terms of creating huge backlogs.' The number of facilities and the scope of the industry outstrips the resources of any single regulator. 'It makes sense to rely on partners,' said Ridley. 'The FDA is so big and the United States is so big. We have the scale. It does make sense to partner with us. But that's conditional on being able to count on us to make those foreign trips.' But Ridley said the U.S. has struggled to staff foreign offices in India and China, major sources of active ingredients in drugs. Regarding the situation in the United States, Health Canada's Godard said 'there's no concern right now in Canada.' She said if a site is particularly important, gaps will be filled in by Canadian inspectors or another partner like Australia. Industry pressures and generic drugs Concerns about inspection protocols come at a time when parts of the industry are under increasing pressure to produce drugs more cheaply. 'I worry most about generic manufacturers because they are in this race to the bottom with their competitors,' said Ridley. He said major U.S. drug purchasers, retailers and wholesalers are looking for the cheapest generic. Generic manufacturers in Canada face similar pressures. 'There's a potential disconnect between how we pay for drugs and our supply chain,' said Tadrous. He said though many hospitals look closely at where they source medications from, drug selection processes in Canada haven't always considered how or where a drug is made. 'For a very long period of time they have been agnostic to how drugs enter the country and the regulator and the payers have sort of been separate,' he said. Generics make up about 20 per cent of product sales by value and 75 per cent of the market share by prescriptions in Canada, according to IQVIA Pharmafocus 2027, a global forecast on pharmaceutical trends used by Health Canada. Expanded national pharmacare is likely to increase demand for generics. Last year Health Canada recalled three generic drugs (Accel-Ondansetron ODT, Mint-Betahistine and PMS-Pirfenidone) due to serious data integrity issues found at India-based Synapse Labs, the site that had tested the products. The European Medicines Agency identified 'irregularities in study data,' raising serious concerns about the bioequivalence of the drugs. Following the recall, the makers of Accel-Ondansetron ODT and Mint-Betahistine submitted new bioequivalence data, according to Health Canada. The regulator concluded the drugs to be safe and equivalent to the brand-name drugs and has granted approval for them to resume selling the products. When asked if industry pressures in the generics space was a concern the department said, 'Health Canada has not identified significant ongoing compliance concerns specific to generic drug manufacturers.' Despite concerns about oversight gaps and mounting pressure on regulators around the world, Health Canada said it is actively adapting. 'We're following the context, we're following the trends, we're following the technologies, we're following what's happening in the pharmaceutical industry to make sure that we're able to meet the demands of tomorrow,' said Godard.

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