Usona Institute

LAFAYETTE, Calif., May 31, 2024 /PRNewswire/ -- The Alexander Shulgin Research Institute (ASRI) has unveiled a groundbreaking discovery in the journal Molecular Pharmacology: the first bifunctional compound that acts as both a 5-HT2A receptor antagonist and a voltage-gated sodium channel blocker. This novel molecule, known as XOB, could revolutionize the treatment landscape for bipolar disorder. Key Findings: Continue Reading ASRI's discovery of XOB marks a significant milestone in psychiatric pharmacology. Post this 1. XOB's Dual Mechanism of Action: ASRI Co-Founder and President, Dr. Nicholas Cozzi, spearheaded the design and synthesis of XOB. His team collaborated with experts from leading institutions, including the University of Michigan-Ann Arbor, Stanford University, Medical College of Wisconsin, Usona Institute, and Promega Corporation. Lead author Dr. Nicholas Denomme, of the University of Michigan-Ann Arbor and Stanford University, guided and performed electrophysiology studies which revealed that XOB had a blocking effect on voltage-gated sodium channels in cultured cells and neurons. ASRI and Usona Institute scientists performed essential physical and chemical analyses of XOB, while researchers at the Medical College of Wisconsin and Promega Corporation assessed serotonin receptor binding and functional effects. 2. Potential Impact on Bipolar Disorder Treatment: Bipolar disorder management often involves a combination of drugs, such as a serotonin receptor antagonist (e.g., quetiapine) and a sodium channel blocker (e.g., lamotrigine). XOB's unique property lies in its ability to perform both functions simultaneously, at similar drug concentrations. Dr. Cozzi emphasized that XOB represents a proof-of-concept, opening doors to safer and more effective treatments for this challenging disease. 3. Polypharmacology: A New Paradigm: XOB exemplifies polypharmacology, wherein a single drug targets multiple disease-related pathways. This approach recognizes that many disorders have complex genetic origins, necessitating multifaceted therapeutic strategies. ASRI's discovery of XOB marks a significant milestone in psychiatric pharmacology. The potential to address bipolar disorder with a single, multifunctional compound could transform patient care and improve outcomes. Further research and clinical trials will determine XOB's efficacy and safety profile. Disclaimer: This press release is for informational purposes only and does not constitute medical advice. Consult a healthcare professional for personalized recommendations. About ASRI: Established on Bicycle Day in 2021 by Dr. Nicholas Cozzi, Dr. Paul Daley, and the late Ann Shulgin, ASRI continues the legacy of the esteemed chemist Alexander Shulgin, renowned for his pioneering work in discovering psychedelic compounds. At the forefront of the burgeoning interest in the potential therapeutic benefits of psychedelics, ASRI remains steadfast in its commitment to applied therapeutics, targeting neurological, neurodevelopmental, neuropsychiatric, pain syndrome, inflammation, and overall wellness enhancement domains. Drawing upon a wealth of knowledge in chemistry, pharmacology, and neuroscience, ASRI is committed to catalyzing positive change in global healthcare. Noteworthy is the Shulgin Vault, housing an extensive repository of over 500 compounds synthesized by Alexander "Sasha" Shulgin and ASRI scientists, offering a rich spectrum of novel variations spanning phenylalkylamines, tryptamines, lysergamides, isoquinolines, cathinones, and more. For more information on ASRI, please visit: . Forward-looking statement: This release contains forward-looking statements regarding ASRI's anticipated future events and outcomes, such as data projections and advancements in drug discovery methods. These statements are based on current expectations and assessments but are subject to various risks and uncertainties. Factors such as the ongoing impact of COVID-19, fluctuations in economic conditions, market dynamics, regulatory constraints, and other variables may cause actual results to differ from those anticipated. While ASRI's management has made reasonable assumptions, the actual outcomes may deviate significantly. It's important to note that ASRI has refrained from making medical assertions about its products, and regulatory bodies like the FDA have not yet evaluated their effectiveness. Rigorous clinical trials are necessary for validation, a process which ASRI has not yet undertaken. Without obtaining the required approvals or conducting essential research, ASRI's performance and operations may be negatively impacted. Therefore, stakeholders should be mindful of these uncertainties when considering the forward-looking statements contained in this release.‍ Media Contact: Kathy Lanser, [email protected] SOURCE Alexander Shulgin Research Institute

MADISON, Wis.--(BUSINESS WIRE)-- Usona Institute announces the launch of its Phase 3 clinical trial, titled "A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Psilocybin in Adults with Major Depressive Disorder (MDD)." Known as the uAspire trial, its launch represents the beginning of an important next stage in the development of psilocybin as a potential therapeutic option for those diagnosed with MDD. "The initiation of the Phase 3 uAspire trial marks an important milestone in the clinical development of psilocybin as a potential new treatment for major depressive disorder," says Dr. Mike Davis, Chief Medical Officer at Usona Institute. "Following the robust safety and efficacy findings from our Phase 2 study PSIL201, the uAspire trial is designed to deepen our understanding of psilocybin’s treatment durability and long-term safety. To ensure broad applicability of the study findings, we are committed to the inclusion of adults from diverse backgrounds and treatment settings, including top academic institutions, clinical research sites, and VA medical centers across the country.” ClinicalTrials.gov Identifier: NCT06308653 Study Details: The uAspire trial is designed to evaluate the efficacy and safety of psilocybin 25 mg as a treatment for MDD that is administered, with psychosocial support, to adults when they experience a major depressive episode. Following an initial 6-week randomized, double-blind treatment period, participants will be monitored for one year to characterize the treatment durability and long-term safety of psilocybin treatment. Further Information: For additional information or for inquiries about participation, please visit the study record at clinicaltrials.gov. About Usona Institute: Usona Institute is a 501(c)(3) nonprofit medical research organization (MRO) that conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Their focus is the treatment of society’s most challenging mental health conditions for which existing treatments fall short. For more information visit .

Chemists Synthesize Novel Series Derived from Mushroom Tryptamine, Revealed in Latest Publication MADISON, Wis.--(BUSINESS WIRE)-- Medicinal chemists at Usona Institute have designed a series of new compounds inspired by norpsilocin, a tryptamine natural product found in psychedelic mushrooms. The research, published this week in ACS Chemical Neuroscience, sheds light on the impact of strategic chemical modifications at a specific region of the norpsilocin molecule, providing new lead compounds in pursuit of psychedelics with optimized therapeutic properties. Key findings reported in the publication include: Structural modifications to norpsilocin result in new compounds with improved ability to enter the brain. Brain activity and potency measurements in animal behavioral models indicate five out of the eight tested compounds can produce psychedelic-like effects. Testing with cell-based models elucidated chemical features important for high activity at the serotonin 2A (5-HT2A) receptor, a common characteristic of all known psychedelics. High-throughput screening experiments demonstrate that compounds in the series activate additional therapeutically relevant receptors across the brain, warranting further research. “Through traditional medicinal chemistry techniques paired with contemporary pharmacology assays, this research builds upon a rich and unique history of psychedelic discovery efforts inspired by natural products,” says Alex Sherwood, lead author on the paper and Head of Medicinal Chemistry at Usona. “We are excited to reveal a new branch on the tree of psychoactive tryptamines.” Usona’s medicinal chemistry lab designed and synthesized the compounds reported in the publication, and the pharmacological studies were carried out in collaboration with the Designer Drug Research Unit of the National Institute on Drug Abuse Intramural Research Program (NIDA IRP) and the National Institute of Mental Health's Psychoactive Drug Screening Program (NIMH-PDSP). Usona Institute is a non-profit medical research organization that takes an open science approach to established findings, therefore making public the scientific discoveries and processes that arise from its research. The study published January 8, 2024, in ACS Chemical Neuroscience is an open access paper. To learn more about Usona, visit About Usona Institute Usona Institute is a 501(c)(3) nonprofit medical research organization (MRO) that conducts and supports pre-clinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines. Its focus is on alleviating depression and anxiety in people for whom current medical treatments fall short in offering relief and a better quality of life. Research reported in this press release was supported by the National Institute on Drug Abuse (NIDA) and National Institute of Mental Health (NIMH) of the National Institutes of Health under award number ZIADA000522 and through a Cooperative Research and Development Agreement with NIDA, and under Contract No. HHSN-271-2018-00023-C with NIMH. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. View source version on businesswire.com: Contacts Kristine Lohman Sr. Communications & Marketing Manager, Usona Institute kristine.lohman@usonainstitute.org Source: Usona Institute View this news release online at: