5-HT1A receptor x 5-HT2C receptor

Psyence’s own psilocybin candidate is being prepared for a phase 2b trial as a potential treatment for patients adjusting to receiving a life-limiting cancer diagnosis. Psyence Biomedical is paying $500,000 in shares to acquire fellow psilocybin-based biotech Clairvoyant Therapeutics and its phase 2-stage alcohol use disorder (AUD) candidate.Privately-held Clairvoyant is currently conducting a 154-person phase 2b trial of a synthetic psilocybin-based candidate in AUD in the European Union and Canada with topline results expected in early 2025. This candidate “nicely" complements Psyence’s nature-derived psilocybin development program, Psyence’s CEO Neil Maresky said in a Sept. 6 release.“Additionally, this proposed acquisition may expand our pipeline into another high-value indication—AUD—with a regulatory pathway that could potentially transition us to a commercial-stage, revenue-generating company,” Maresky added.Psilocybin is the active ingredient in magic mushrooms. Nasdaq-listed Psyence’s own psilocybin candidate is being prepared for a phase 2b trial as a potential treatment for patients adjusting to receiving a life-limiting cancer diagnosis, a psychological condition called adjustment disorder. “With this proposed acquisition, we would have line-of-sight to two important phase 2 data readouts that, if successful, would position us as a leader in the development of psychedelic-based therapeutics to treat a range of underserved mental health and related disorders that are in need of effective new treatment options,” Maresky said in the same release.As well as the $500,000 in shares that Psyence will pay Clairvoyant’s disposing shareholders, Psyence will potentially make two more share-based payments of $250,000 each based on specific milestones. Separately, Psyence has set aside up to $1.8 million to settle Clairvoyant’s liabilities, such as its clinical trial costs.Psyence and Clairvoyant are far from the only biotechs dabbling in psilocybin, with Compass Pathways posting successful phase 2 results in post-traumatic stress disorder (PTSD) this year. But the wider psychedelics space suffered a high-profile blow this summer when the FDA turned down Lykos Therapeutics’ application to use MDMA to treat PTSD.

AI Simulation on MIRA1a Showcases Significant Potential Advantages Over Plant-Based Medical Marijuana Related to Anxiety, Appetite and Cognition BALTIMORE, Dec. 4, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, has released new data from artificial intelligence (AI) simulations that show that, compared to plant-based medical marijuana, there may be significant potential advantages to the therapeutic potential of MIRA1a, such as its potential to offer a superior anti-anxiety treatment, increased cognition and without the increased appetite associated with THC. The simulations on MIRA1a were conducted in conjunction with the Company's strategic collaboration with InSilicoTrials, a company specializing in leveraging AI and simulations to enhance drug and medical device development. In silico analysis is a computational technique that uses AI to predict the interaction between drugs and their targets. This innovative approach facilitates the virtual screening of compounds and the assessment of their pharmacological profiles before physical trials, expediting drug development and increasing the precision of therapeutic targeting. "The results of our AI analysis work with InSilicoTrial's efforts continue to validate MIRA1a as a potential pharmaceutical candidate within a multi-billion-dollar market to address the unmet needs of millions with anxiety and cognition issues with potentially fewer negative side effects than THC," said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. "Following positive results from recent in vivo animal testing and research indicating MIRA1a's potential therapeutic effects, without the common negative side effects seen with THC even at high doses, we believe these targeted studies with InSilicoTrials employing artificial intelligence and machine learning further underscores MIRA1a's position as a promising development in the evolution of neuropharmacological therapies as we work towards the goal of filing an Investigational New Drug ("IND") Application with the Food and Drug Administration ("FDA")." Decoding MIRA1a's Potential: A Possible Breakthrough in Anxiety, Appetite, and Cognition Through meticulous computer-aided simulations, researchers have uncovered MIRA1a's predicted ability to initiate a response at three pivotal receptors in the brain— Serotonin 1a (5-HT1a), Serotonin 2c (5-HT2c), and Dopamine D1 receptors. Third-party studies indicate that THC has no predicted activity at any of these three receptors, highlighting MIRA1a's apparent unique properties and potential as an intervention for neurological disorders. Unlocking Anxiety Relief: 5-HT1a Receptor Activation The simulations suggest that MIRA1a's agonistic action on the 5-HT1a receptor aligns with established anxiolytic properties in medications like Buspirone and certain SSRIs. This finding could potentially result in providing a new therapy for anxiety disorder interventions by addressing disrupted signaling associated with this receptor. Battling Appetite Concerns: 5-HT2c Receptor Modulation The in silico analysis reveals MIRA1a's interaction with the 5-HT2c receptor, suggesting its potential to avoid the appetite related side effects often linked to THC. Drawing parallels with Lorcaserin, known for its FDA approved appetite-suppressing effects, MIRA1a stands out as a potentially viable solution for those seeking neuropharmacological relief from anxiety and cognitive impairment without the side effect of an increase in appetite that accompanies THC. Cognitive Enhancement: Dopamine D1 Receptor Activation MIRA1a's engagement with the Dopamine D1 receptor suggests a potential pathway for cognitive enhancement. With the potential to influence learning and memory, MIRA1a's activation of the D1 receptor may pave the way for novel interventions in disorders associated with cognitive impairment. "In the groundbreaking field of neuropharmacology, artificial intelligence and machine learnings have ushered in a new era of drug discovery and analysis," said Adam Kaplin, MD, Ph.D., President and Chief Scientific Officer of MIRA Pharmaceuticals. "Through the lens of AI, one gains a more complete demonstration of MIRA1a's potential properties at receptors that are not affected by THC. MIRA1a is uniquely positioned to potentially provide anti-anxiety effects, mitigate THC's known side effects of increased appetite, and promote enhanced cognition, making it an exceptional candidate for addressing complex neuropsychiatric conditions." Luca Emili, Chief Executive Officer of InSilicoTrials, added, "Through this collaboration, InSilicoTrials and MIRA Pharmaceuticals are on a mission to optimize and de-risk drug development by using machine learning-based tools. Leveraging our advanced in silico platform and AI expertise, we contributed to enhance the development of MIRA1a, demonstrating the immense potential of collaborative innovation in the pharmaceutical sector." For investors and industry leaders, MIRA1a represents not only a potential scientific breakthrough but also a significant commercial opportunity to meet the urgent need for additional neuropharmacological therapies following clinical trials and undergoing the FDA approval process. About InSilicoTrials InSilicoTrials is an emerging startup founded by a team of life science, cybersecurity and digital innovation experts, which aims to revolutionize Healthcare through an innovative digital simulation platform. We specialize in leveraging AI and simulations to enhance drug and medical device development. Using in silico techniques, we analyze data to predict safety and efficacy of potential compounds, aiding Pharma, MedTech companies, and researchers in efficient, cost-effective advancement by minimizing extensive clinical trials. InSilicoTrials' cloud-based platform offers advanced tools for in silico trials analyses, facilitating the integration of AI and simulation technology into development workflows. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. The Company's novel oral pharmaceutical marijuana, MIRA1a, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA1a, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. MIRA has an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation (MDSI). The U.S. Drug Enforcement Administration (DEA)'s scientific review of MIRA1a and Ketamir-2 concluded that neither would be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations. Additional information about the Company is available at: . Forward-Looking Statements This press release may contain forward-looking statements about MIRA Pharmaceuticals, Inc. ("MIRA," "we," "us," or "our"). In some cases, you can identify forward-looking statements by terminology such as "anticipate,' "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would," or the negative of these terms or other comparable terminology. These forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including risks and uncertainties regarding our ability to develop and obtain regulatory approval for our product candidates, Ketamir-2 and MIRA1a. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, levels of activity, performance or achievements of and those of our industry to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Some of these risks and uncertainties are identified in our Registration Statement on Form S-1 filed with the SEC (File No. 333-273024) and in our other filings with the SEC, which are available at . You should not place undue reliance on any forward-looking statement. We undertake no obligation to update or revise publicly any of the forward-looking statements after the date hereof to conform the statements to actual results or changed expectations except as required by law. General Note This press release discusses product candidates that are in early stage pre-clinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration. No representations are made as to the safety or effectiveness of these product candidates for the uses for which they are being studied. There is no assurance that either product candidate will proceed through development or will receive FDA approval for marketing. SOURCE MIRA Pharmaceuticals, Inc.

The trial is being conducted at the University of Alabama at Birmingham (UAB) under noted psychedelic researcher Dr. Peter Hendricks This exploratory study is the first investigation of the influence of low-dose psilocybin on human subjects suffering from demoralization TORONTO, Oct. 17, 2023 /PRNewswire/ - Diamond Therapeutics Inc. ("Diamond"), a clinical-stage drug development company focused on non-hallucinogenic, psychedelic-based therapies for use in the treatment of mental health, today announced the enrollment of the first patient in an FDA-approved clinical trial conducted at the University of Alabama at Birmingham (UAB). The principal investigator is Dr. Peter S. Hendricks, a clinical psychologist and professor at UAB's Health Behavior Department in the School of Public Health. This study is referred to as the UAB-Diamond Trial. Dr. Hendricks has published nearly 100 peer-reviewed manuscripts with 3,504 citations. His work has been recognized in media outlets, including National Geographic, The Economist, Business Insider, New York Times, Newsweek, U.S. News & World Report, Scientific American, Vogue, and Michael Pollan's bestseller, "How to Change Your Mind." Dr. Hendricks was recently named the first editor-in-chief of the journal Psychedelic Medicine, published by Mary Ann Liebert, Inc. He has provided keynote addresses on the topic of psychedelics nationally and internationally, including at the FDA and several other leading institutions. The UAB-Diamond Trial will enroll 60 patients to evaluate the treatment of low doses of psilocybin in demoralization, which involves feelings of hopelessness and meaninglessness. The trial will assess initial signals of efficacy, feasibility, and potential mechanisms of action. Psilocybin will be administered across a series of low doses that are not expected to produce hallucinogenic or other subjective effects, which may limit broad use. Demoralization is believed to be pervasive in the wake of COVID-19, resulting in a widely experienced unmet need for treatment. "This study is significant because it is the first to test low doses of psilocybin in the treatment of demoralization and is also among the first to test the effectiveness of low doses of psilocybin in a clinical rather than a healthy sample group," notes Dr. Hendricks. Dr. William J. Tyler serves as a scientific advisor and Chief Technical Officer to Diamond, as well as professor at UAB's School of Engineering-Biomedical Engineering and head of the UAB's Alabama BRAIN Lab, although he is not actively involved in the UAB-Diamond study. Dr. Tyler says, "Diamond has achieved many notable milestones, including cellular studies, animal studies, and studies with healthy humans. Commencing the UAB-Diamond Trial is a landmark moment for Diamond and for the future of psychedelic medicine. The research community is keen to understand low-dose psilocybin's impact on a clinical population. It is our sincere hope that these efforts will help provide solutions to the mental health crises facing our nation." Diamond Therapeutics Diamond Therapeutics is a clinical-stage drug development company founded to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic take-at-home prescription treatments that hold potential for use across a broad patient cohort —maximizing the positive impact better drugs can have on global mental health. To learn more about Diamond, visit About UAB Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is an internationally renowned research university and academic medical center with over $700 million in research awards annually, as well as Alabama's largest single employer, with some 28,000 employees, and has an annual economic impact exceeding $12.1 billion on the state. The pillars of UAB's mission include education, research, innovation and economic development, community engagement, and patient care. Learn more at . Cautionary Statements Regarding Forward-Looking Information This news release includes certain "forward-looking information" under applicable Canadian securities legislation. Forward-looking information includes statements other than statements of historical fact that can be identified by phrases such as "expects", "anticipates", "intends", "aims", "plans" and "believes", and are based on expectations, estimates and projections as at the date of this news release. Forward-looking statements in this news release include, but are not limited to, the potential effects of low dose psilocybin and other psychedelic treatments, the potential use in treating mental health conditions and the timing and completion of Diamond's clinical programs and trials. Forward-looking information is necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; delay or failure to receive applicable regulatory approvals; that factors may occur which impede Diamond's future business plans; the results of continued development, marketing and sales; and other factors beyond the control of Diamond. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking information. Diamond disclaims any intention or obligation to update or revise any forward-looking information in this news release, whether as a result of new information, future events or otherwise, except as required by law. SOURCE Diamond Therapeutics Inc.