The Poster Highlights that SOPH-110S, a Novel Long-Acting Injectable ALDH2 Inhibitor, Was Safe and Well Tolerated Across All Doses in a Human SAD Study
Chicago, IL, September 28, 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 its poster, titled “SOPH-110S: A novel injectable ALDH2 inhibitor: Proof of mechanism and preliminary human results,” has been accepted as a late-breaking presentation at the annual International Society of Addiction Medicine (ISAM) congress being held in Rotterdam, Netherlands. The poster presentation will be conducted by Sophrosyne’s Chief Medical Officer, Dr. Randall Marshall, on Friday, October 2nd, and highlights data from study 110S-111 and the conclusion that SOPH-110S shows the potential to overcome key limitations of disulfiram and to be a superior treatment option for patients desiring to maintain abstinence from alcohol.
“We are pleased that the data from the first-in-human single ascending dose (SAD) study with our novel lead product has been selected for a late-breaking presentation at ISAM,” 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 U.S. 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 we believe have the potential to bring significant clinical benefit to the millions of patients suffering from AUD.”
The data from the study highlights that single doses of SOPH-110S ranging from 5mg to 40mg were safe and well tolerated with only non-dose dependent mild and transient pain and/or redness at the site of injection observed. In addition, the data indicates a linear PK and short half-life with no accumulation expected.
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 company website at www.sophrosynepharma.com.
