Novamind (NM) began a Phase II trial on psilocybin for depression, which is sponsored by the non-profit Usona Institute.
MindMed’s latest study compared the experiences of LSD and psilocybin in high and low doses.
Subjects were assessed on a scale that measures changes in consciousness like feelings of unity and bliss, ego dissolution, auditory and visual sensations, spiritual experiences, and insightfulness.
Researchers found “no evidence of qualitative differences in altered states of consciousness” between the substances, except that LSD lasted longer. Any other differences could be attributed to the dose, not the substance.
They found that 20 mg psilocybin is equivalent to 100 µg LSD (a 1:200 ratio), and that body weight had no influence on the concentration of the drugs in blood plasma.
Robust Portfolio of Psychedelic-Inspired Molecules Positions Enveric to Achieve Global Patent Protection to potentially Cover Millions of Novel Pharmaceutical Candidates
NAPLES, Fla., March 1, 2022 —Enveric Biosciences(NASDAQ: ENVB) (“Enveric” or the “Company”), a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines, today announces that it has filed its 10th Patent Cooperation Treaty (“PCT”) patent application directed to tryptamine-based derivative molecules, completing the Company’s broad series of PCT applications covering this family of compounds.
The Company’s robust tryptamine-derivative intellectual property portfolio claims novel molecules structurally related to certain naturally occurring psychedelics, such as dimethyltryptamine (DMT), psilocybin, psilocin, and 5-MeO-DMT. Some of the naturally occurring molecules are themselves currently being investigated by researchers around the world as potential treatments for a broad range of psychiatric and neurologic disorders including depression, anxiety, schizophrenia, obsessive-compulsive disorder, posttraumatic stress disorder, eating disorders, pain, autism, and Alzheimer’s disease.1,2
“With the aim of optimizing commercial and regulatory success, a primary focus of Enveric is the creation of novel molecules with improved pharmaceutical characteristics that are also protected by composition of matter, manufacturing, and method-of-use patent claims,” said Dr. Peter Facchini, Chief Innovation Officer, Enveric. “Enveric’s extensive intellectual property portfolio enables the Company to invest in, and harness, the therapeutic potential of these molecules. In our pursuit to maximize the potential of our large and diverse library of novel and protected drug candidates, we intend to pursue out-licensing opportunities to collaborate with other leading drug development companies with a similar focus on delivering benefits to patients suffering from psychiatric and neurologic disorders”.
References:
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a neuroscience-focused pharmaceutical company developing next-generation, psychedelic-inspired mental health medicines. Enveric’s robust pipeline supports drug development from the clinic to commercialization aimed to help millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more. For additional 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”, “proposed”, “is expected”, “budgets”, “scheduled”, “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, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements 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 to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned pre-clinical or clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned pre-clinical or clinical trials; the ability to establish that potential products are efficacious 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 market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. 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 (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.
Investor Contacts
Valter Pinto / Allison Soss
KCSA Strategic Communications
212.896.1254 / 212.896.1267
valter@kcsa.com / asoss@kcsa.com
Media Contacts
Natalie Dolphin
Enveric Biosciences Inc.
416.706.6364
ndolphin@enveric.com
View original content:https://www.prnewswire.com/news-releases/enveric-biosciences-files-portfolio-of-patent-applications-for-tryptamine-based-molecules-301492335.html
SOURCE Enveric Biosciences
Producing psilocybin is wildly expensive if you want it to meet the FDA’s Good Manufacturing Practice (GMP) standards. With all the testing required, it can cost $7,000-$10,000 for a single gram of psilocybin.
Core One Labs (COOL) developed a new production method involving fermentation of bacteria that could reduce the cost of production to under $100 per gram.
Hopefully this will make psilocybin therapy much more affordable!
Filament Health (FH) will license its natural psilocybin to ATMA Journey Centers for use in clinical trials, including an upcoming phase I trial on healthy subjects, which has already received Health Canada approval.
Anorexia has a higher mortality rate than any other psychiatric condition, as patients have a high risk of death by both suicide and organ failure.
Current treatments work for less than half of patients, which is why Imperial College London is preparing to study psilocybin therapy as an alternative.
The school is recruiting female patients who have had a diagnosis for at least 3 years and have tried other forms of treatment without success. They’ll each receive 3 doses of psilocybin, and researchers will use several MRIs and EEG scans to understand the effects of the treatment.
TORONTO, Feb. 17, 2022 (GLOBE NEWSWIRE) — Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) (“Mindset” or the “Company”), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today announced that, under its Co-operative Psychedelics Evaluation Platform (“COPE”) program with InterVivo Solutions Inc. (“InterVivo”), the Company has identified new pharmacological insights related to the mechanisms of action and bioavailability of 5-MeO-DMT and other first generation psychedelics. Specifically, Mindset has further developed standard pharmacokinetics and drug discrimination data and protocols across LSD, psilocybin, 5-MeO-DMT, and now psilocin.
Comparisons of psilocybin and 5-MeO-DMT benchmarking data have revealed potential differences in the mechanism of action related to the hallucinogenic experience of 5-MeO-DMT versus psilocybin. Furthermore, data suggests that the oral bioavailability of 5-MeO-DMT increases at higher doses in rodents.
“In rodent drug discrimination studies, 5-HT2A antagonists completely block the ability of rats to perceive psilocybin, whereas the same antagonists do not completely block the effects of 5-MeO-DMT, suggesting that the perceptual experience of 5-MeO-DMT is due not only to 5-HT2A receptor agonism,” said Joseph Araujo, Chief Scientific Officer of Mindset. “Pharmacokinetics studies also show 5-MeO-DMT is not orally bioavailable at low doses, but at higher doses, 5-MeO-DMT is bioavailable and its half-life is prolonged, indicating that its metabolism is saturable. This exemplifies the importance of studying a range of doses of psychedelics for benchmarking purposes.”
“Mindset is developing a spectrum of differentiated, next-generation medical psychedelics with the goal of improving several factors compared to first-generation psychedelic drugs,” said James Lanthier, CEO of Mindset. “Thanks to this detailed benchmarking data, we’re better positioned to pre-clinically evaluate and assess drug candidates, which are essential towards reaching our treatment goals.”
The COPE Program is a translational testing platform developed in cooperation with InterVivo to introduce an industry standard against which the performance and efficacy of breakthrough psychedelic medicines are compared and assessed. Through this platform, Mindset and InterVivo intend to establish the first comprehensive psychedelics benchmark reference data set by evaluating a broad range of psychedelic drugs through a proprietary program of in vivo tests conducted at InterVivo’s facility. The COPE platform is anticipated to represent an invaluable tool to guide the development of next-generation psychedelic compounds and improve patentability and value of new potential drug assets.
To watch a video of Mindset’s CEO discussing the announcement in greater detail, please visit: https://youtu.be/kS6Rc0BhIK4
About InterVivo Solutions Inc.
InterVivo Solutions is Canada’s top neuroscience contract research organization, offering translational research services with a focus on next-generation neuroscience drug discovery. InterVivo and its sister company, Transpharmation, offer a wide range of contract services that are focused on discovery and development of neurological and neuropsychiatric new chemical entities including in vivo proof of concept, drug metabolism, pharmacokinetics and early safety research studies for a global client base.
www.intervivo.com / www.transpharmation.co.uk
About Mindset Pharma Inc.
Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next-generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next-generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin in addition to its own proprietary compounds. The company has a co-development agreement with the McQuade Center for Strategic Research and Development, a member of the Otsuka Pharmaceuticals family of companies, for its short-duration compounds, Mindset Families 2 & 4.
For further information on Mindset, please visit our website at www.mindsetpharma.com.
For more information, please contact:
Investor Contact:
Allison Soss/Tim Regan
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 212-896-1267/ 347-487-6788
Media Contact:
McKenna Miller
KCSA Strategic Communications
Email: MindSet@kcsa.com
Phone: 949-606-6585
Company Contact:
James Lanthier, CEO
Email: jlanthier@mindsetpharma.com
Jason Atkinson, VP, Corporate Development
Email: jatkinson@mindsetpharma.com
Phone: 416-479-4094
Forward-Looking Information
This news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “would”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Forward-looking information is based on the opinions and estimates of management at the date the information is provided and is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. Additional information regarding risks and uncertainties relating to the Company’s business are contained under the heading “Risk Factors” in the Company’s annual information form for the financial year ended June 30, 2020 dated March 5, 2021. The forward-looking information included in this news release is made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking information to reflect new information, subsequent events or otherwise, except as required by applicable law.
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
One of the few concerns that experts have about microdosing is the long term impact on heart health. Psilocybin binds to 5-HT2B receptors, which could increase risk of heart valve disease with frequent use.
Mydecine (MYCO) developed a group of patent-pending molecules that bind only to 5-HT2A receptors, making them safer for microdosing. The company aims to administer these compounds through a microdosing patch to eliminate another side effect: nausea.
Vancouver, British Columbia – February 16, 2022 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is pleased to announce that Nova Mentis successfully completed an oral microdose psilocybin preclinical study, in the laboratory of Dr. Viviana Trezza, Rome Tre University, Rome, Italy. The results exceeded all expectations with the findings that a very low dose of the Company’s proprietary psilocybin significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of fragile X syndrome (FXS).
“The science team led by Dr. Hausman, together with Dr. Viviana Trezza from Roma Tre University, continues to deliver promising preclinical results. The recent oral microdose data set not only confirms but exceeds our original injectable formulation results,” says Will Rascan, CEO of NOVA. “The clear positive data is critical as we prepare to submit our clinical trial application to Health Canada for a Phase 2A study evaluating psilocybin microdose therapy for fragile X syndrome.”
Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder for which no treatments exist. Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent monogenic cause of ASD (1). The aim of the present study was to evaluate various oral doses of the company’s proprietary psilocybin in a rat model of FXS. A major question to be answered in this preclinical study was whether microdose therapy could be the potential treatment of choice in ASD, as compared to single dose macrodose therapy with associated hallucinogenic and other side effects.
Psilocybin efficacy was tested in FXS, in the Fmr1 knock-out (Fmr1 KO) rat (Fmr1-Δexon 8) – an established genetic model of FXS (1). Wild type control and Fmr1 KO animals were treated with 0.1 mg/kg and 0.3 mg/kg oral psilocybin every other day for 6 treatments, over a 2-week period, and on day 18 underwent object recognition testing. We had great results! Both 0.1 and 0.3 mg/kg were effective in reversing the cognitive impairment displayed by Fmr1 KO animals. Moreover, the 0.1 mg/kg worked best, and did not have any apparent side effects. The 0.1 mg/kg dose in the rat translates into approximately 1.5 mg oral dose in a 70 kg person.
“I am elated to be able to report to the medical community that at long last we may have opened the door to treatment of ASD, an unmet medical need, that has a devastating impact on the patient, family and society,” stated Marvin S. Hausman MD, Chairman of NOVA’s Scientific Advisory Board. “The rat model that we used mimics key autistic-like features in humans and the study results strongly supports an important role for microdose therapy of
FXS. Moreover, this positive response in the rat of every other day oral 0.1 mg/kg psilocybin, equivalent approximately to a 1.5 mg dose in a 70 kg person, may be the treatment of choice to modulate behavioural changes and cognitive defects, and perhaps have a longer term constructive neuroplastic response in the brain without the need for large doses of psychedelic drugs with associated detrimental hallucinogenic side effects.”
In addition, the Company announces a non-brokered private placement of up to $1,000,000 (the “Placement”).
The Company will issue up to 20,000,000 units at a purchase price of $0.05 per unit. Each unit will consist of common share of the Company and one transferable share purchase warrant. Each warrant will entitle the holder to acquire one additional common share at an exercise price of $0.075 for a period of 18 months from the closing date.
The Company will use the proceeds from the Placement towards the launch of its ASD observational study, Health Canada Phase 2A CTA and general working capital clinical trials. Finder’s fees may be payable in accordance with the policies of the Canadian Securities Exchange. All securities issued under the Placement will be subject to a statutory hold period of four months and one day from issuance.
References:
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve psilocybin orphan drug designation in both the United States and European Union.
The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).
For further information on the Company, please visit www.novamentis.ca or email info@novamentis.ca.
On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
Phone: 778-819-0244
Toll Free: 1-833-542-5323
Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc
Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.
SOURCE: NOVA MENTIS LIFE SCIENCE CORP.
VANCOUVER, BC (GLOBE NEWSWIRE – February 16, 2022) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional and novel psychedelic compounds for the health and wellness sector, is pleased to report that Health Canada has added the Company’s wholly-owned subsidiary Optimi Labs Inc. to a list of approved suppliers under the Special Access Program (SAP). With a mission to provide compassionate, frontline solutions to Canada’s growing mental health crisis, the Company plans to supply psychedelics like psilocybin to those truly in need.
Announced on January 5, 2022, the SAP allows qualified medical practitioners to request access to Schedule 3 controlled substances such as psilocybin on a case-by-case emergency basis. Prior to the new regulatory amendments, medical practitioners were prohibited from requesting access to psilocybin and MDMA for individual psychedelic-assisted psychotherapy. The amendments have the potential to positively affect the lives of people experiencing serious mental health conditions and end-of-life distress when other therapies have failed, are unsuitable or are unavailable in Canada.
Optimi’s CEO, Bill Ciprick, says the SAP is already having a positive impact on patients in need and will provide the Company with the right avenue to develop and supply the demand for natural psilocybin.
“Optimi is committed to bringing transformative change to those suffering from debilitating palliative and non-palliative mental health trauma,” said Ciprick. “We will leave no stone unturned in our effort to provide the safest and most efficacious natural psilocybin product in the world, because frankly we need to get this right for those depending on us for support and healing.”
“Between the science, research, and good manufacturing practices, the SAP is an excellent opportunity for all of us to learn, grow and expand our knowledge capacity and improve treatment outcomes for many people in the years to come,” added Ciprick.
With the Company’s Dealer’s License approved by Health Canada earlier this month, Optimi has received requests for supply agreements from potential partners interested in the Company’s new EU-GMP compliant 10,000 sq. ft. facility located in Princeton, British Columbia. Once fully commercialized, the production facility will position Optimi as a global frontrunner in the cultivation, extraction, and vertical integration of high-grade all-natural psilocybin.
“Establishing Optimi’s presence in the psychedelic market begins with trust, which we believe we have earned through our in-house expert research and world-class advisory team, and by setting the gold standard in GMP compliance,” added JJ Wilson, Optimi’s Chairman of the Board.
Optimi plans to host a grand opening of its new facility this May and is committed to building awareness and education about the benefits of the SAP to physicians qualified to recommend the program to patients.
Bill Ciprick
Chief Executive Officer
Optimi Health Corp.
ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN)
Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also been granted a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.
FOR FURTHER INFORMATION CONTACT:
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://optimihealth.ca/
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
The CSE does not accept responsibility for the adequacy or accuracy of this release.
