Chicago, IL, July 13, 2026 – Sophrosyne Pharmaceuticals, a clinical stage biopharmaceutical company dedicated to developing novel therapies for patients suffering from Alcohol Use Disorder (AUD), related conditions, and other brain health afflictions, announced today that it has appointed Dr. Ashwani Singal to its Scientific Advisory Board, joining the existing group of highly esteemed academic and industry Company advisors. Dr. Ashwani Singal is a lead author on the American College of Gastroenterology guidelines for Alcohol-associated Liver Disease (ALD), and a co-author on guidelines on vascular disorders of the liver and nutritional management of patients with cirrhosis as well as revised guidelines on alcohol-associated liver disease. He has been a leader in recognizing the newly defined liver disease of metabolic and alcohol-associated liver disease (metALD), characterized by adverse effects on the liver of alcohol use in the 80-100 million persons in the US with steatotic liver disease. MetALD afflicts approximately 17 million people in the United States. It is a unique disease with the risk of cirrhosis, hepatocellular carcinoma, and mortality different from those with metabolic-associated steatotic liver disease (MASLD) or alcohol-associated liver disease (ALD). Its treatment includes achieving and sustaining abstinence from alcohol consumption.
“We are thrilled to have Dr. Singal join our scientific advisory board,” stated Herm Cukier, CEO of Sophrosyne Pharmaceuticals. “His expertise on the impact of alcohol across a wide range of liver diseases and his leading efforts in defining and understanding the rapidly emerging category of metALD will be of tremendous assistance in our efforts as we develop novel ALDH2 inhibitors. For the millions of Americans who need to achieve and sustain abstinence from alcohol consumption, Sophrosyne’s emerging portfolio of new chemical entities holds the promise of bringing transformational therapeutic options to a disease state that results in nearly 200,000 deaths per year in the US and an annual economic impact of more than $250 billion dollars. We look forward to working closely with Dr. Singal on the development of our products.”
Dr. Singal is a professor of medicine at the University of Louisville School of Medicine, Director of clinical trials program in liver diseases, transplant hepatologist at the Jewish Hospital and Trager Transplant Center in Louisville KY. In addition, he is a research scientist at the Robley Rex VA Medical Center in Louisville, KY, USA. He has over 385 original peers reviewed articles in national / international journals and book chapters. In 2024, Dr. Singal was recruited to the top 2% of world scientists database that is created and maintained by Elsevier in collaboration with Stanford University. Apart from editorial activities for major GI and liver society journals, Dr. Singal is an Associate Editor for Clinical Translational Gastroenterology, Current Hepatology Reports, Digestive Liver Disease, and Journal of Clinical and Experimental Hepatology. In addition to serving the NIH study section as a review of scientific grants, Dr. Singal is a lead author on ACG guidelines (ALD, vascular liver disorders, and nutrition in liver disease). Dr. Singal has been awarded the prestigious Edgar Achkar Visiting Professorship by the ACG, the Dr. Reddinger Lectureship at the University of Louisville, Dr. Deepak Amarapurkar Oration, and Dr. BD Pimparkar Oration. He has chaired the AASLD special interest group on ALD (2020-2021) and Liver Section of the AGA Council (2024-2026). Currently, he chairs the ALD section for CLD Foundation and is an Advisor to the AASLD SIG Task Force.
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 approximately 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 brain health afflictions. The Company has initiated a clinical study with its lead new chemical entity (NCE) in the United States for AUD and is planning to further advance its other novel development programs. The Company’s NCEs are globally patent protected through the mid-2040s. Sophrosyne has been granted FDA Fast Track Designation in the treatment of AUD for its lead asset, SOPH-110S.
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 employs an adaptive design using an efficient methodology to identify and secure 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 approximately 12 months from the time of initiation.
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
