Establishes First of its Kind Chemical Combination of a Novel ALDH2 Inhibitor with a GLP-1 for the Potential Treatment of Alcohol Use Disorder (AUD)
Chicago, IL, July 16, 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 created a new class of compounds for the treatment of Alcohol Use Disorder (AUD) by chemically combining its novel ALDH2 inhibitor, SOPH-110S, with a GLP-1 agonist. Sophrosyne has filed provisional patents as the creator of this new class of compounds as well as for its specific new products. Preclinical studies demonstrated that SOPH-110S is a highly potent and dose-dependent inhibitor of ALDH2. Furthermore, studies across several species highlighted an acceptable safety profile and NOAEL, as well as no off-target effects in a panel of 84 common targets, no CYP interactions, and no meaningful inhibition of the hERG channel. Across a multitude of clinical studies, GLP-1agonists have demonstrated the possibility of reducing the amount of alcohol consumed as well as the craving for alcohol consumption in patients suffering with AUD. The combination of the ALDH2 inhibitor and GLP-1 agonist pathways in a single product may offer synergistic benefit for AUD patients.
“Congratulations to the Sophrosyne team for this innovative step forward with the potential to bring significant clinical benefit for the tens of millions of patients suffering from AUD,” stated Herm Cukier, CEO of Sophrosyne Pharmaceuticals. “Sophrosyne is committed to developing novel new chemical entities for the treatment of AUD, a disease that has seen little to no innovation in nearly 4 decades despite being one of the leading causes of premature and preventable death in the US and around the world. This catastrophic condition is responsible for nearly 200,000 deaths every year in the US and has a negative annual economic impact of roughly $250 billion dollars. We look forward to further advancing our entire portfolio of new chemical entities which now also includes our ALDH2 and GLP-1 combination.”
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 200,000 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.
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 companywebsite at www.sophrosynepharma.com
