Enveric Biosciences Lead Drug Candidate EB-003 Demonstrates Positive Effects in Preclinical Model of Post-Traumatic Stress Disorder (PTSD)
In fear conditioned mice, oral administration of EB-003 significantly decreased context-induced freezing behavior when measured one-hour post-dose (p < 0.05) indicating a positive therapeutic effect with extinction of contextual fear after a single dose. These results were in line with the therapeutic effects observed with MDMA, which was used as a positive control in this study. MDMA is a psychedelic controlled substance that has demonstrated clinical benefit in the treatment of PTSD in human trials, although it is not approved by the FDA.
The pairing of electrical shock stimulus with a controlled environment generates context-based traumatic memories leading to freezing behaviors when the subject is re-exposed to the same environment. This well-established translational rodent model, performed by a third-party lab, is designed to induce a potent, trauma-related state of fear using a Pavlovian association paradigm.
'Only a few medications have been approved by the FDA for the treatment of PTSD, including the serotonin reuptake inhibitors (SSRIs) paroxetine and sertraline,' said Joseph Tucker, Ph.D., CEO and Director of Enveric. 'Only 20% to 30% of PTSD patients experience full remission with these drugs and it takes two to three weeks of SSRI administration before clinical and neuronal benefits become apparent. Clearly, there is enormous unmet need in PTSD, which has yet to be addressed with meaningful innovation.'
Dr. Tucker added: 'Research has implicated impaired hippocampal neuroplasticity as key underlying features of patients struggling with PTSD. We are very encouraged that a single dose of our lead neuroplastogen, EB-003, facilitated rapid fear extinction in mice.'
In light of this new data, EB-003, a next-generation neuroplastogen that may enhance hippocampal neuroplasticity without causing hallucinations, has the potential to significantly improve treatment outcomes for this chronic and debilitating mental health condition, representing a major opportunity in an underserved market.
About Enveric Biosciences
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.
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 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.
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Bloomberg
an hour ago
- Bloomberg
Big Take: Hims' Big Bet on Weight-Loss Shots
When a shortage of brand-name weight-loss drugs like Ozempic and Wegovy cleared the way for companies like Hims to fill the gap with cheaper, compounded versions, customers came flocking. But in February, the US Food and Drug Administration announced the shortage was over, leaving the company's strategy in flux and some investors worried. On today's Big Take podcast, host David Gura and Bloomberg healthcare reporter Madison Muller track how Hims became the king of copycat weight-loss drugs and what's next for the company as it fights to hold onto the crown.
Yahoo
2 hours ago
- Yahoo
FDA warns this cookware could be leaching lead into your food
Cookware that is likely still on shelves could be leaching lead into your food, the Food and Drug Administration said in an Aug. 13 warning. The FDA became aware of the issue after testing pots made by an Indian manufacturer and finding that they were made with Hindalium/Hindolium or Indalium/Indolium, metal alloys that are made from aluminum, aluminum alloys and brass. These substances are common in some types of imported cookware, said the FDA, but are not used in the U.S. due to their tendency to leach lead into food cooked or stored within. There is no known level of lead exposure that is considered safe and some people are at even higher risk of adverse effects, warned the agency, including young children, people of child-bearing age and people who are breastfeeding. Here's what to know. Which cookware is included in the warning? The FDA identified the manufacturer, an Indian aluminum cookware company called Saraswati Strips Pvt. Ltd that sells products under the brand name Tiger White. However, it was unable to contact a distributor to initiate a recall, meaning the impacted products are not being pulled from shelves on a large scale. Impacted products are Kadais/Karahis, or deep pots used for simmering and frying, with brand name Tiger White. The FDA tested two specific items at a Mannan Supermarket in Jamaica, New York, labeled "Pure Aluminium Utensils Tiger White RTM No: 2608606 An ISO 9001:2015 Certified Co. Saraswati Strips Pvt. Ltd. India." However, the FDA warns that these are not the only potentially affected products and more could be added as the investigation continues. What to do if you have an impacted product Consumers should check their homes for any listed products or similar cookware and throw them away. They should not attempt to refurbish or repair the cookware. If you are concerned about possible lead exposure, the FDA advises contacting your health care provider. Retailers and distributors are responsible for ensuring the safety of cookware they sell, said the FDA, meaning those that may have the affected products on the market should use the FDA's lead leach testing protocol for cookware or another testing method. They are also encouraged to consult with the FDA on the updated safety and regulatory status of food-related products. Questions for the FDA related to this topic can be sent to premarkt@ What is the risk of lead exposure? The FDA does not allow the use of lead in products related to food, including components of cookware and other food contact surfaces. Lead is toxic to humans and can be ingested when a product like the cookware leaches it into items it comes into contact with. Even low levels of exposure are linked to serious health issues, including fatigue, headache, stomach pain, vomiting or neurologic changes, according to the FDA. Exposure is especially dangerous to developing fetuses and children, potentially causing learning difficulties, low IQ and behavioral changes. Even when they don't show obvious symptoms, babies and children can be permanently impacted by elevated levels of lead in their blood, especially due to their smaller size and metabolism. This article originally appeared on USA TODAY: FDA warns about pots that may be leaching lead into food Solve the daily Crossword
Los Angeles Times
3 hours ago
- Los Angeles Times
What's Really in Your Kids' Furniture? How to Find Safe, Chemical-Free Pieces for Your Home
LA Times Studios may earn commission from purchases made through our links. Most parents don't plan for their child's first taste of at some point, it happens. A tooth mark on the crib rail, a sticky mouth print on the dresser corner. In that moment, the question isn't just 'will it stain?' but 'is this safe?' As the realities of chemical exposure in kids' rooms come to light, decoding the labels on furniture has become more important. Thanks to mounting research and a new breed of food-safe furniture makers, there's starting to be clarity (and accountability) behind the labels that line showroom floors and pop up in your social feeds. Here's how to cut through the greenwashing, decode certifications, and shop with genuine peace of mind. A recent study put numbers to what every parent fears: more than two dozen phthalates, flame retardants, and other chemicals are hiding in children's bedrooms, not just in old toys but in the beds, nightstands, and even the mattress itself. Under the body heat and weight of a child, chemical emissions spike. Translation: your child's so-called safe space may be a chemical factory, especially if you don't know what's actually in that new furniture purchase. 'This isn't scare-mongering; these are real, measurable exposures, not 'trace' amounts,' says Arin Schultz, Chief Growth Officer at Naturepedic. 'Most people don't realize just how many harmful chemicals they're bringing into their children's bedrooms when they buy conventional furniture. So many pieces are made with glues, adhesives, and synthetic materials that can off-gas for years. It's a hidden issue in the children's furniture industry that deserves much more attention'. 'Non-toxic' and 'eco-friendly' are unregulated terms, says Schultz. 'When we talk about 'food-safe' furniture, we're really talking about finishes, i.e., the coatings and sealants that come in direct contact with kids' skin and mouths,' Schultz explains. 'If your child were to lick the bed rail or nibble on a dresser corner, there wouldn't be any harmful chemicals to worry about with a food-safe product.' Schultz continues that while 'food-safe' does not have a certification that goes with it in terms of furniture, there is a specific testing protocol. 'Food-safe means the finish meets FDA protocols for food-contact surfaces, just like a dinner plate or a spoon would,' Schultz says. 'It's an extra level of reassurance for parents who want to know that what's on the furniture is as safe as what goes in their child's mouth.' Certified food-safe finishes are tasteless, odor-free, and meet or exceed the same requirements as FDA-approved dinnerware. The best examples: solid, responsibly sourced wood, water-based coatings, and adhesives so clean you could, well, lick them. That cute nightstand or bookshelf in your child's room may have more in common with a chemistry set than we'd like to think. Phthalates, used to soften plastics, are known to disrupt hormones and have been well-documented by the CDC for their effects on children's health. Formaldehyde, found in adhesives and engineered woods, is classified as a carcinogen by the EPA and remains a mainstay in the construction of mass-market furniture. Flame retardants, often hailed as lifesaving, have instead been repeatedly linked by NIH studies to developmental and neurological problems. Then there are organic compounds. That 'factory-fresh' smell clinging to new dressers or cribs is more than a novelty. According to the EPA, it's the scent of chemicals evaporating into your child's space. Great. And when furniture warms up, gets heavy use, or starts to wear, the rate of chemical off-gassing gets worse. As Schultz explains, 'Kids are uniquely vulnerable: they breathe faster, their bodies are still developing, and let's be honest, if it's within reach, it's probably going in their mouths.' In a world of splashy marketing, what separates a truly safe product from empty promises? Certifications are where the details matter. If a brand can't offer them, keep shopping. Schultz points to transparency and independent testing as the only meaningful standards. 'If the language feels too broad, it's worth questioning. Also, be wary of prices that seem too good to be true. Solid hardwood furniture with real safety testing costs more to make than mass-produced particleboard with synthetic finishes.' Look for specifics: GREENGUARD® Gold certification means products are tested for hundreds of VOCs. FSC® labels guarantee responsibly sourced wood. MADE SAFE® screens for thousands of potential toxins. Some manufacturers, like Naturepedic, go further by batch testing for lead, phthalates, formaldehyde, and heavy metals. FDA food-contact compliance should never be assumed. Ask directly whether finishes meet the relevant standards. Any reluctance from a manufacturer to disclose these details is your cue to move on. 'Transparency and third-party testing are key,' Schultz insists. A safe product will come with receipts. Look for clear documentation on what's in the finishes and adhesives, and insist on solid wood over ambiguous 'wood products.' If you see claims like 'eco' or 'non-toxic' but can't find third-party verification, consider it a warning sign. 'Proprietary blend' ingredients? Vague descriptions? Walk away. Price is another indicator. Genuinely food-safe, well-crafted furniture rarely comes at a bargain-basement rate. Brands like Max & Lily are upfront about using GREENGUARD® Gold finishes on their solid pine pieces. And the new wave of heirloom-quality makers (Oeuf, Milton & Goose, and Piccalio) are direct about their use of natural, food-grade materials. Bigger names like Avocado are now featuring GREENGUARD® Gold collections too. The research is catching up: indoor air quality, chemical exposure, and children's health are all inextricably linked. U.S. regulations are beginning to reflect this, albeit slowly, as attention to issues like PFAS and formaldehyde grows. Schultz puts it plainly: 'Over the past decade, parents have become a lot more informed about indoor air quality and everyday exposures. We've seen this with organic food, non-toxic cleaning products, even mattresses. Now that same awareness is shifting to what kids are breathing in and touching day after day in their bedrooms.' Don't get distracted by cute hardware or a clever product name. Before you buy, ask for real answers: Will food-safe become the rule, not the exception? Schultz thinks so. 'Not just as a premium feature but as the baseline standard for kids' furniture. We're at this intersection of wellness and home design where people are rethinking what they bring into their homes, realizing it matters just as much as the food on their plates or the air they breathe.' Style doesn't have to come at the expense of safety anymore. The real measure of quality isn't a trend or a label, but the assurance that what's in your child's room is as safe as it is well made. When a bed rail is finished with food-safe materials, there's nothing left to second-guess.
