D1 receptor

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.

Long-term safety data collected in pediatric patients treated with investigational drug ecopipam; durable treatment effect reported with no evidence of tachyphylaxis CHICAGO--(BUSINESS WIRE)-- An open-label extension study of 121 pediatric patients with Tourette syndrome evaluated the safety pro the investigational drug ecopipam for up to 12-months of treatment. No new safety concerns were identified based on an evaluation of adverse events, physical exams, vital signs, laboratory results and safety scales, according to Emalex Biosciences. A durable effect was also observed over the course of the study based on evaluation of the patients’ motor and vocal tics, which were assessed every three months. The findings were first presented at the International Congress of Parkinson’s Disease and Movement Disorder Society in Copenhagen and will be highlighted at the Child Neurology Society Annual Meeting this week in Vancouver. Patients in the open-label study previously completed a Phase 2b clinical trial involving more than 150 children and adolescents that found ecopipam significantly reduced the total number of motor and vocal tics compared to placebo, according to a study published in the journal Pediatrics. In this open-label study, ecopipam was generally well tolerated, with 33.1% (40/121) of patients reporting treatment-related adverse reactions (ARs). The most common ARs were anxiety (6.6%), insomnia (5.8%), and somnolence (5.8%). One patient experienced a serious adverse reaction (obsessive thoughts) and 11.6% (14/121) of patients discontinued the study due to adverse events. In addition, patients did not have observable evidence of excessive weight gain or metabolic side effects commonly reported with antipsychotic agents, which are often used to treat patients with Tourette syndrome. Ecopipam is a first-in-class dopamine-1 receptor antagonist. The antipsychotic agents currently approved to treat Tourette syndrome target the dopamine-2 receptor. Ecopipam is the lead candidate for Emalex Biosciences, a clinical-stage biopharmaceutical company founded by Paragon Biosciences. Emalex is currently conducting a Phase 3 clinical trial of ecopipam for the treatment of Tourette syndrome at more than 90 sites in North America and Europe. Tourette syndrome is a chronic, childhood-onset neurodevelopmental disorder characterized by motor and vocal tics. The condition is associated with both increased mortality and significant morbidity. In the majority of individuals, Tourette syndrome substantially impacts day-to-day physical and social function. “The fact that most patients who completed the Phase 2b study asked to participate in the open-label extension points to the unmet medical needs for people with Tourette syndrome. The 12-month data supports the continued development of ecopipam as a first-in-class novel therapy for children and adolescents with Tourette syndrome,” said Emalex Biosciences Chief Medical Officer Frederick Munschauer, MD. About Ecopipam Emalex’s first-in-class development candidate ecopipam, a novel investigational compound that is being studied as a potential treatment for certain central nervous system disorders, blocks the actions of the neurotransmitter dopamine at the D1 receptor. Dopamine is a neurotransmitter in the central nervous system, and its receptors have been classified into two “families” based on their genetic structure: “D1” (including subtypes D1 and D5) and “D2” (including subtypes D2, D3, and D4). D1 receptor super-sensitivity may be a mechanism for the repetitive and compulsive behaviors associated with Tourette syndrome. Currently approved therapies for the treatment of Tourette syndrome act at D2 receptors. Ecopipam has been shown to be generally well tolerated in clinical trials conducted to date and has received Orphan Drug and Fast Track designation from the FDA for the treatment of patients with Tourette syndrome. Adverse events affecting primarily the central nervous system have been reported in clinical trials conducted to date, including headache, fatigue, somnolence, insomnia, restlessness, anxiety, depression and rarely, suicidal ideation. About Emalex Biosciences Emalex Biosciences was created by Paragon Biosciences to develop new treatments for central nervous system disorders. Emalex is in late-stage development of a new class of drug targeting the D1 receptor for patients with Tourette syndrome and other conditions that have limited treatment options. Visit to learn more. About Paragon Biosciences, LLC Paragon Biosciences is a global life science leader that creates, builds and funds innovative biology-based companies in three key areas: cell and gene therapy, biology engineering and advanced biotechnology. Our portfolio companies use biology to accelerate scientific breakthroughs that solve some of society’s most challenging problems. Learn more at .

Parkinson's disease is a progressive disorder that is caused by the degeneration of nerve cells in the part of the brain called the substantia nigra, which controls movement. These nerve cells die or become impaired, losing the ability to produce an important dopamine chemical. Studies have shown that symptoms of Parkinson's develop in patients with an 80% or greater loss of dopamine-producing cells in the substantia nigra. Most Parkinson's patients are treated with medications to relieve the symptoms of the disease. These medications work by stimulating the remaining cells in the substantia nigra to produce more dopamine (levodopa medications) or by inhibiting some of the acetylcholine that is produced (anticholinergic medications), therefore restoring the balance between the chemicals in the brain. LAS VEGAS, April 19, 2023 /PRNewswire/ -- DelveInsight's ' Parkinson's Disease Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline Parkinson's disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Parkinson's disease pipeline domain. Key Takeaways from the Parkinson's Disease Pipeline Report DelveInsight's Parkinson's disease pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for Parkinson's disease treatment. Key Parkinson's disease companies such as Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., NeuroDerm Ltd., Pharma Two B, Serina Therapeutics, Sun Pharma Advanced Research Company Limited, CuraSen Therapeutics, Inc., Takeda, Xoc Pharmaceuticals, Sumitomo Pharma Co., Ltd., XWPharma, Athira Pharma, Aptinyx, VistaGen Therapeutics, Inc., 1ST Biotherapeutics, Inc., Novo Nordisk A/S, AstraZeneca, MedImmune, Anavex Life Sciences Corp., Living Cell Technologies, Intra-Cellular Therapies, Inc., Alkahest, Inc., Kissei Pharmaceutical Co., Ltd., and others are evaluating new Parkinson's disease drugs to improve the treatment landscape. Promising Parkinson's disease pipeline therapies in various stages of development include Tavapadon, IkT-148009, NLY01, PT320, BIIB122, Prasinezumab, KDT-3594, AAV2-GDN, AKST4290, anle138b, ITI-214, NTCELL, Buntanetap, ANAVEX2-73, ATH-1017, NE3107, MEDI1341, AZD0328, Liraglutide, UB-312, LY03003, FB-101, AV-101, ABBV-951, NYX-458, DSP-9632P, Valiloxybate, SER-214, UCB7853, TAK-071, XC130-A10H, K0706, Talineuren, Pirepemat, Lu AF28996, WD-1603, CVN424, CST-103, NBTX-001, MSK-DA01, Aadipose-Derived Mesenchymal Stem Cells, ND0612, P2B001, 1ST-103, 1ST-105, and others. In January 2023, Neurocrine Biosciences and Voyager Therapeutics announced the formation of a new strategic collaboration to advance multiple gene therapies for the treatment of neurological diseases. The collaboration includes Voyager's preclinical, intravenously administered GBA1 gene therapy program for Parkinson's and other GBA1-mediated diseases, combining a GBA1 gene replacement payload with novel capsids from Voyager's TRACERTM (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) platform. In addition, Neurocrine Biosciences and Voyager have agreed to collaborate on three new gene therapy programs directed to rare CNS targets, each also leveraging Voyager's novel TRACER capsids. In October 2022, Biogen Inc. and Denali Therapeutics Inc. announced that dosing has commenced in the global Phase 3 LIGHTHOUSE study to evaluate the efficacy and safety profile of BIIB122 (DNL151), as compared to placebo in approximately 400 participants with Parkinson's disease and a confirmed pathogenic mutation in the leucine-rich repeat kinase 2 (LRRK2) gene. In September 2022, Neuron23, Inc. an early-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases, and QIAGEN announced a collaboration to develop a companion diagnostic for Neuron23's LRRK2 inhibitor for Parkinson's disease. Request a sample and discover the recent advances in Parkinson's disease drug treatment @ Parkinson's Disease Pipeline Report The Parkinson's disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Parkinson's disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Parkinson's disease clinical trial landscape. Parkinson's Disease Overview Parkinson's disease is a progressive disorder caused by nerve cell degeneration in the substantia nigra, a part of the brain that controls movement. These nerve cells die or become impaired, losing the ability to produce dopamine, an important chemical. According to research, symptoms of Parkinson's disease develop in patients who have an 80% or greater loss of dopamine-producing cells in the substantia nigra. Dopamine works typically in tandem with other neurotransmitters to help coordinate the millions of nerve and muscle cells involved in the movement. This balance is disrupted when there is insufficient dopamine, resulting in tremors (trembling in the hands, arms, legs, and jaw), rigidity (stiffness of the limbs), slowness of movement, and impaired balance and coordination - the hallmark Parkinson's disease symptoms. The cause of Parkinson's disease is largely unknown. However, as potential causes of the disease, theories involving oxidative damage, environmental toxins, genetic factors, and accelerated aging have been discussed. The majority of Parkinson's patients are given medications to alleviate their symptoms. These Parkinson's disease medications work by either stimulating the remaining cells in the substantia nigra to produce more dopamine (levodopa medications) or inhibiting some of the acetylcholine produced (anticholinergic medications), restoring the balance of chemicals in the brain. Find out more about drugs for Parkinson's disease @ New Parkinson's Disease Drugs A snapshot of the Parkinson's Disease Pipeline Drugs mentioned in the report: Learn more about the emerging Parkinson's disease pipeline therapies @ Parkinson's Disease Clinical Trials Parkinson's Disease Therapeutics Assessment The Parkinson's disease pipeline report proffers an integral view of Parkinson's disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Parkinson's Disease Pipeline Report Coverage: Global Parkinson's Disease Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Parkinson's Disease Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Parkinson's Disease Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Intravenous, Oral, Parenteral, Subcutaneous Parkinson's Disease Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem Cell, Vaccine Parkinson's Disease Therapeutics Assessment By Mechanism of Action: Dopamine D1 receptor agonists, Dopamine D5 receptor agonists, Bcr-abl tyrosine kinase inhibitors, Glucagon like peptide 1 receptor agonists, LRRK2 protein inhibitors, Alpha-synuclein inhibitors, Dopamine receptor agonists Key Parkinson's Disease Companies: Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., NeuroDerm Ltd., Pharma Two B, Serina Therapeutics, Sun Pharma Advanced Research Company Limited, CuraSen Therapeutics, Inc., Takeda, Xoc Pharmaceuticals, Sumitomo Pharma Co., Ltd., XWPharma, Athira Pharma, Aptinyx, VistaGen Therapeutics, Inc., 1ST Biotherapeutics, Inc., Novo Nordisk A/S, AstraZeneca, MedImmune, Anavex Life Sciences Corp., Living Cell Technologies, Intra-Cellular Therapies, Inc., Alkahest, Inc., Kissei Pharmaceutical Co., Ltd., and others. Key Parkinson's Disease Pipeline Therapies: Tavapadon, IkT-148009, NLY01, PT320, BIIB122, Prasinezumab, KDT-3594, AAV2-GDN, AKST4290, anle138b, ITI-214, NTCELL, Buntanetap, ANAVEX2-73, ATH-1017, NE3107, MEDI1341, AZD0328, Liraglutide, UB-312, LY03003, FB-101, AV-101, ABBV-951, NYX-458, DSP-9632P, Valiloxybate, SER-214, UCB7853, TAK-071, XC130-A10H, K0706, Talineuren, Pirepemat, Lu AF28996, WD-1603, CVN424, CST-103, NBTX-001, MSK-DA01, Aadipose-Derived Mesenchymal Stem Cells, ND0612, P2B001, and others. Dive deep into rich insights for new drugs for Parkinson's disease treatment; visit @ Parkinson's Disease Medications Table of Contents For further information on the Parkinson's disease pipeline therapeutics, reach out @ Parkinson's Disease Drug Treatment Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, among others. Parkinson's Disease Epidemiology Forecast Parkinson's Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Parkinson's disease epidemiology trends. 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Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Parkinson's Disease-Related Dementia Market Parkinson's Disease-Related Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease-related dementia companies, including AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP