Chicago, IL, November 3, 2025 – Sophrosyne Pharmaceuticals, a clinical stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from Alcohol Use Disorder (AUD), related conditions, and other drug addictions, announced today that it has formed a Scientific Advisory Board (SAB) consisting of internationally recognized academic and professional experts who have made contributions to the understanding and treatment of Alcohol Use Disorder (AUD) and other associated neuropsychiatric conditions. The SAB will provide important guidance to Sophrosyne as it pursues development of its novel compounds for the treatment of AUD and other future strategic considerations. Sophrosyne plans to start a comprehensive phase-1 study with its lead product, SOPH-110S, in the coming months.
“We are thrilled to have such esteemed academic advisors in the fields of Alcohol Use Disorder (AUD and addiction as we begin human clinical studies with our lead compound, SOPH-110S, in the coming months,” stated Herm Cukier, CEO of Sophrosyne Pharmaceuticals. “Our proprietary asset is a highly potent and selective agent targeting the inhibition of ALDH2, an enzyme required for the breakdown of ethanol in humans and holds the promise of bringing new clinical solutions for a disease state that has had little innovation over the last several decades. Alcoholism remains a leading cause of preventable morbidity and mortality in the U.S. and around the world with more than 200 thousand estimated deaths per year in the U.S. alone. Sophrosyne’s novel compounds hold the promise of transforming the treatment experience for the roughly 30 million patients of AUD in the U.S. and hundreds of millions more globally.”
Raymond F. Anton, M.D. is a Distinguished Emeritus University Professor of Psychiatry and Behavioral Science at the Medical University of South Carolina in Charleston, SC where he has held the Thurmond Wellness Endowed Chair. He was the Scientific Director of an NIAAA funded Alcohol Research Center for over 25 years and is the founder and immediate past Director of the Clinical Neurobiology Laboratory in the Department of Psychiatry as well as a former Director of the Center for Drug and Alcohol Programs at MUSC.
Dr. Anton is a Past-President of the Research Society on Alcoholism (RSA) and served on the Board of Directors (Secretary) of the International Society for Biomedical Research on Alcoholism (ISBRA). He is an elected Fellow to the American College of Neuropsychopharmacology and a Distinguished Life Fellow of the American Psychiatric Association. He is currently serving as Founder and Chair of the Alcohol Clinical Trial Initiative (ACTIVE) workgroup, a public-private consortium of academics, government agencies and the pharmaceutical industry whose task it is to define the best methods for clinical trials for alcohol use disorders (AUD). This group initiated a process that culminated in the FDA approving a new drinking reduction efficacy measure for AUD regulatory clinical trials in January 2025. He also has consulted for numerous Pharmaceutical Companies over the course of his career.
He is internationally known for his expertise in AUD pharmacotherapy and the use of lab tests to identify drinking patterns. He had been funded by the NIH for over 25 years, has published over 330 scientific articles and book chapters, and has conducted over 25 (federal and industry funded) clinical trials in Alcohol Use and Psychiatric Disorders. His research work incorporated brain imaging and genetics into alcohol treatment trials to better predict who will respond to alcohol pharmacotherapy. He currently has a pharmacogenetic patent under review. Dr. Anton helped pioneer the clinical utility of the CDT blood test for the detection and monitoring of heavy alcohol use and was a member of the International Federation of Clinical Chemistry workgroup on CDT measurement standardization. He is a recipient of the prestigious Henri Begleiter Award for “Research Excellence” by the Research Society on Alcoholism. He has consulted for several pharmaceutical companies and others in the development of treatments, rating scales, and biomarkers for Alcohol Use Disorder.
Kelly J. Clark, MD, MBA, DFAPA, DFASAM, board certified in both addiction medicine and psychiatry, is a practicing physician, business leader and recognized expert on issues related to substance misuse involving opioids as well as other illicit and prescription substances. Known for building consensus across diverse stakeholder groups, Dr. Clark works actively across the medical, scientific, criminal justice, and business communities to transform addiction care into evidence-based, cost-effective practice.
Dr. Clark is author of Guide for Future Directions for the Addiction and OUD Treatment System, from Prevention Treatment and Recovery Group of the National Academy of Medicine’s Action Collaborative in Countering the US Opioid Epidemic, and also an author of Integrating Telehealth and Traditional Care in Chronic Pain Management and Substance Use Disorder Treatment: An Action Agenda for Building the Future State of Hybrid Care. Dr. Clark also served as a member of the Steering Committee, a Co-Chair of the Research Data and Metrics Workgroup, and a Co-Chair of the Telemedicine Group. She is a member of the Milken Institute Public Health Advisory Board and National Rx and Heroin Abuse Summit Advisory Board, as well as Founder and Chair of the Forensic Addiction Medicine Special Interest Group of the American Society of Addiction Medicine (ASAM).
Considered one of the nation’s leading experts on substance use disorder and addiction care, she is frequently invited to speak about the disease of addiction and needed systems of treatment to federal organizations and other drug policy stakeholders, which has included the United States Presidential Opioid Commission, Bipartisan Heroin and Opioid Task Force, the Food and Drug Administration (FDA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Office of Comptroller General, the National Association of Attorneys General, the National Association for the Advancement of Science, Pew Trusts, National Safety Council, National Business Group on Health, American Psychiatric Association Foundation’s Judges and Psychiatrists Initiative, and the Council of State Governments’ Justice and Mental Health Collaboration Program.
Dr. Michelle Lofwall, board-certified in psychiatry and addiction medicine, is a Professor in the Departments of Behavioral Science and Psychiatry and the Bell Alcohol and Addictions Endowed Chair at the University of Kentucky (UK). She received her bachelor’s degree from Northwestern University in Psychology and her MD and Masters in Pathology from Chicago Medical School. She completed her internship, psychiatry residency, and a fellowship in behavioral pharmacology at Johns Hopkins University. She is the inaugural medical director of UK’s First Bridge Clinic, which provides low barrier comprehensive substance use disorder treatment within the UK Center on Drug and Alcohol Research.
Dr. Lofwall’s research has been funded by both industry and the NIH and has included medications development that led to FDA approvals for long-acting buprenorphine implants and depot injections for opioid use disorder treatment, as well as physician training, improving care of complex patients with substance use and comorbid conditions, and development of novel peer and care navigator work force training to improve workforce and community health literacy and patient engagement in the continuum of care. She was elected as a Distinguished Fellow of American Society of Addiction Medicine (ASAM) and the American Psychiatric Association, is a past ASAM board member, codirector of the American Academy of Addiction Psychiatry’s annual addiction treatment review course, and recipient of the national Dole/Nyswander Award from the American Association for the Treatment of Opioid Dependence that honors individuals who have completed extraordinary service and commitment to improving lives of patients in the opioid treatment system. She has received numerous teaching and mentoring awards, was an expert panel member for SAMHSA’s Treatment Improvement Protocol on Medication Treatment for Opioid Use Disorder, where she is currently working on its update, and past invited speaker to the National Academy of Medicine.
The study is titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Exploratory Alcohol Challenge Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Profile of SOPH-110S for Subcutaneous Injection in Healthy Adult Subjects.” The study is an adaptive design using an efficient methodology to identify and secure confirmatory evidence of the safety, tolerability, and efficacy for the ideal dose of SOPH-110S to proceed with in future patient studies. Analysis of the data will also inform on the durability of the efficacy effect for SOPH-110S. The study will consist of up to 104 subjects and is expected to be completed within 12 months from the time of initiation. Sophrosyne expects to start the study by early 1Q26.
Alcohol Use Disorder (AUD), encompassing the conditions referred to as alcoholism, alcohol abuse, and alcohol addiction, is a chronic disease characterized by uncontrolled drinking and the preoccupation with alcohol despite adverse social, occupational, or health consequences. AUD is the inability to control drinking due to both a physical and emotional dependence on alcohol. Considered a brain disorder, AUD may create lasting changes in the brain, thus perpetuating the need and consumption of alcohol despite the resulting consequences. AUD affects approximately 30 million Americans and has a relapse rate of more than 90% with today’s treatments. It is a leading cause of preventable morbidity and mortality leading to more than 200 thousand deaths in the U.S. Hundreds of millions of people are estimated to suffer from AUD worldwide.
Sophrosyne Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing and commercializing novel therapies for patients suffering from Alcohol Use Disorder (AUD), related conditions, and other drug addictions. The Company is planning to initiate clinical studies with its leading new chemical entity (NCE) in the United States in the coming months for AUD, as well as further advance its other novel development programs. The Company’s NCEs are patent protected globally through 2042.
This press release contains, or may contain, forward-looking statements that involve significant risks and uncertainties. Actual results may differ materially from those expressed or implied in such forward-looking statements due to various factors and circumstances, without limitation, many of which are outside of Sophrosyne Pharmaceuticals’ control. Readers are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date of this press release. Sophrosyne Pharmaceuticals undertakes no obligation to update or revise its forward-looking statements to reflect future events, circumstances, or otherwise.
Neil Chapman, Investor Relations, at nchapman@sophrosynepharma.com or visit the company website at www.sophrosynepharma.com.
