neuropsychiatric disorders – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Mon, 14 Mar 2022 16:46:33 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.4 Bright Minds Biosciences Announces Successful Completion of 28-Day Toxicology Studies and Advancement to First-in-Human Clinical Trial https://mjshareholders.com/bright-minds-biosciences-announces-successful-completion-of-28-day-toxicology-studies-and-advancement-to-first-in-human-clinical-trial/ Mon, 14 Mar 2022 16:46:33 +0000 https://www.cannabisfn.com/?p=2940625

Ryan Allway

March 14th, 2022

Psychedelics, Top News


VANCOUVER, British Columbia, March 14, 2022 (GLOBE NEWSWIRE) — Bright Minds Biosciences (“Bright Minds,” “BMB” or the “Company”) (Nasdaq: DRUG) (CSE: DRUG), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain, today announced the successful completion of 28-day repeat-dose toxicity studies for its lead product, BMB-101. Importantly, there were no major toxicological findings after twice daily oral administration of BMB-101 throughout the study period. The studies were conducted by the Company’s contract research partner, ITR Laboratories Canada in Baie d’Urfé, Québec, Canada.

Dr. Revati Shreeniwas, Bright Minds’ Chief Medical Officer, stated, “Dravet Syndrome, a severe form of epilepsy characterized by frequent, prolonged seizures, is a terribly debilitating disease and, unfortunately, remains an area of high unmet medical need. We’re encouraged and hopeful that BMB-101 will provide a new and effective approach to its treatment. These data, generated in our 28-day toxicology studies, provide further support for advancing our clinical program,” concluded Dr. Shreeniwas.

Repeat-dose oral toxicity studies were conducted in mice and dogs. These Good Laboratory Practice (GLP) compliant studies found that BMB-101, at doses up to 40 and 30 mg/kg/day in mice and dogs, respectively, were well tolerated at all dose levels. These data provide new information on a lack of major toxic effects after 28 days, including a lack of any effect to target organs. A no-observed-adverse-effect level (NOAEL) was identified in both species, which will be used in selecting starting dose levels and for establishing safety criteria for human exposure.

“We are delighted to have completed this important milestone, which is pivotal for supporting our forthcoming first-in-human clinical trial, currently expected to begin in 2Q22,” said Ian McDonald, Bright Minds’ Chief Executive Officer. “We have now officially entered the clinical development stage for our lead product, BMB-101, which represents an exciting new chapter for the Company and, hopefully, therapeutic alternative for patients suffering from Dravet Syndrome.”

About BMB-101

BMB-101, a 5-HT2C selective and biased agonist, has demonstrated compelling activity in a host of in-vitro and in-vivo non-clinical tests. Compared to Locaserin, BMB-101 exhibits strong Gq signaling coupled with minimal beta arrestin recruitment. Mechanistically, Serotonin (5- Hydroxytryptamine, 5-HT) is a monoamine neurotransmitter widely expressed in the central nervous system, and drugs modulating 5-HT have made a major impact in mental health disorders. Central 5-HT systems have long been associated with the control of ingestive behavior and the modulation of behavioral effects of psychostimulants, opioids, alcohol and nicotine. Over the past decade, the various 5-HT receptor subtypes have been cloned and characterized. Results of clinical trials and animal studies indicate that 5-HT2C up receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use.

About Dravet Syndrome

Dravet syndrome is an epilepsy syndrome that begins in infancy or early childhood and can include a spectrum of symptoms ranging from mild to severe. Children with Dravet initially show focal (confined to one area) or generalized (throughout the brain) convulsive seizures that start before 15 months of age (often before age one). These initial seizures are often prolonged and involve half of the body, with subsequent seizures that may switch to the other side of the body. These initial seizures are frequently provoked by exposure to increased temperatures or temperature changes, such as getting out of a bath. Other seizure types emerge after 12 months of age and can be quite varied. Status epilepticus – a state of continuous seizure requiring emergency medical care – may occur frequently in these children, particularly in the first five years of life. Dravet syndrome affects an estimated 1:15,700 individuals in the U.S., or 0.0064% of the population (Wu 2015). Approximately 80-90% of those, or 1:20,900 individuals, have both an SCN1A mutation and a clinical diagnosis of DS. This represents an estimated 0.17% of all epilepsies. As an area of high, unmet medical need, there currently exist only three FDA-approved medications for the treatment of DS: (1) Fintepla® (fenfluramine), which has a black-box label; (2) Diacomit® (stiripentol) and (3) Epidolex® (cannabidiol).

About Bright Minds

Bright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as psilocybin.

Investor Contacts:
Lisa Wilson
In-Site Communications, Inc.
489 Fifth Avenue, 29th Floor
New York, NY 10017
E: [email protected]

Josh Blacher
Bright Minds Biosciences, Inc.
19 Vestry Street
New York, NY 10013
E: [email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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atai Life Sciences announces the launch of PsyProtix, to develop a precision psychiatry approach for Treatment-Resistant Depression (TRD) https://mjshareholders.com/atai-life-sciences-announces-the-launch-of-psyprotix-to-develop-a-precision-psychiatry-approach-for-treatment-resistant-depression-trd/ Mon, 11 Oct 2021 16:25:33 +0000 https://www.cannabisfn.com/?p=2935496

NEW YORK, Oct. 11, 2021 (GLOBE NEWSWIRE) — atai Life Sciences (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced the launch of PsyProtix, a new platform company formed with Chymia LLC, a Duke University biotechnology spinout. PsyProtix is a precision psychiatry company focused on developing therapeutics for treatment-resistant depression (TRD) and other mental health indications.

PsyProtix takes a precision psychiatry approach, an emerging field that aims to treat disorders by factoring each patient’s variability in genes, metabolism, environment, and lifestyle. Traditionally, psychiatric patients are diagnosed and treated based on guidelines and protocols designed for the majority, which can often lead to trial and error as physicians attempt to best meet each individual patient’s needs.

Precision psychiatry is designed to allow physicians to prescribe treatments specifically targeted to the individual, rather than relying on the trial and error approach and/or adding on treatments, such as antidepressants or antipsychotics, in the quest to achieve a therapeutic benefit.

Over 300 million people suffer with a major depressive disorder (MDD) worldwide, with a third of these patients diagnosed with TRD. Direct medical costs for TRD patients are estimated to be two to three times higher than non-TRD MDD patients. These statistics highlight the importance and potential of a mechanistically targeted therapeutic approach. PsyProtix will focus on metabolomic mechanisms underlying depression symptoms for certain patients with the goal of deriving more tailored treatments.

“Our view is that each patient is unique, meaning that any given patient will likely have specific individual needs,” said Srinivas Rao, Chief Scientific Officer and co-founder of atai Life Sciences. “This emerging technology adapts to the variability of conditions, such as depression, with the aim of allowing patients with psychiatric disorders to potentially be diagnosed and treated more accurately and efficiently according to their specific needs. It’s an honor to be collaborating with Professor Rima Kaddurah-Daouk and her team at Duke, given their great work in advancing the research of metabolomics and their study of neuropsychiatric disorders.”

Dr. Kaddurah-Daouk, is a Professor of Psychiatry and Behavioral Sciences in Duke’s School of Medicine. She leads large NIH funded consortia to implement a precision medicine approach for the study of neuropsychiatric diseases where the metabolome is used to capture net influences of diet exposome gut microbiome and genome on brain health and disease.

The work licensed by Duke to start PsyProtix captures efforts of a large number of scientists working collaboratively under the Mood Disorder Precision Medicine Consortium which is led by a Duke principal investigator (PI). Their approach has the promise to potentially optimize the selection of drugs most effective for each patient, easing the healing journey in important and impactful ways.

About atai Life Sciences
atai is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. atai was founded in 2018 as a response to the significant unmet need and lack of innovation in the mental health treatment landscape. atai is dedicated to acquiring, incubating and efficiently developing innovative therapeutics to treat depression, anxiety, addiction, and other mental health disorders. atai’s business model combines funding, technology, scientific and regulatory expertise with a focus on psychedelic therapy and other drugs with differentiated safety profiles and therapeutic potential. By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines across its companies, seeking to effectively treat and ultimately heal mental health disorders. atai’s mission is to bridge the gap between what the mental healthcare system currently provides and what patients need. atai has offices in New York, London, and Berlin. For more information, please visit www.atai.life.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors discussed under the caption “Risk Factors” in atai’s prospectus pursuant to Rule 424(b) filed with the U.S. Securities and Exchange Commission (“SEC”) on June 21, 2021, as such factors may be updated from time to time in atai’s other filings with the SEC. atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Investor Contact:
Greg Weaver
atai – Chief Financial Officer
Email: [email protected]

Media Contact:
Camilla Dormer
atai – VP of Communications
Email: [email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

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