Groundbreaking Research Paves the Way for a Potential New Treatment for Alcohol Use Disorder

Research consistently shows that alcohol consumption is harmful to health, increasing the risk of cardiovascular disease, cancer, other serious diseases, and premature death. According to the World Health Organization (WHO), Alcohol Use Disorder is the leading risk factor for death among men under the age of 50 worldwide. Despite affecting millions of people, treatment options remain limited, and only around three percent of patients currently receive pharmacological treatment. Many patients experience insufficient efficacy or discontinue treatment prematurely, highlighting the urgent need for new therapeutic alternatives.

– Our ambition is to develop a treatment that can help more patients reduce their alcohol consumption and improve their quality of life, says Bo Söderpalm, Professor and Senior Consultant at the Addiction Clinic at Sahlgrenska University Hospital.

The development of SO-001 is based on nearly three decades of research into how alcohol affects the brain’s reward system and dopamine regulation. Through both preclinical and clinical studies, researchers have investigated how different mechanisms in the brain influence alcohol consumption and alcohol craving. This extensive body of research ultimately led to the development of Sobrera Pharma’s drug candidate, SO-001.

– Alcohol affects the brain’s reward system and dopamine release. After prolonged alcohol consumption, the dopamine system can change in ways that contribute to continued drinking and relapse. Our previous studies have produced results indicating that treatment with varenicline may reduce alcohol consumption in patients, says Bo Söderpalm.

The research team therefore decided to further develop the concept by combining varenicline with bupropion, two well-established active pharmaceutical ingredients with complementary mechanisms of action. The positive findings from earlier studies formed the foundation for the establishment of Sobrera Pharma in 2019.

– Sobrera’s objective is to develop SO-001 as a new treatment option for patients with Alcohol Use Disorder. We are now advancing towards the next important milestone, the planned Phase II clinical trial. At the same time, we continue to strengthen the company’s intellectual property portfolio and international development strategy, says Ann-Charlotte Rosendahl, CEO of Sobrera Pharma.

A New Treatment Concept

Sobrera’s treatment concept is based on a modern approach in which complete abstinence from alcohol is not necessarily the primary treatment goal. For many patients, a significant reduction in alcohol consumption can provide substantial health benefits and a markedly improved quality of life.

– Many patients find the step towards complete sobriety difficult. An important treatment goal, or intermediate milestone, is therefore to help patients reduce their alcohol consumption to levels associated with lower medical risks and a better quality of life. Our ambition is also to develop a simple treatment regimen that supports long-term adherence and sustained treatment, says Ann-Charlotte Rosendahl.

Sobrera expects to conduct additional clinical studies over the coming years. If the development programme progresses according to plan and the necessary regulatory approvals are obtained, the company’s ambition is to bring the treatment to market within approximately five years.

– Because SO-001 is based on two well-characterized active pharmaceutical ingredients, the development programme benefits from extensive existing knowledge, including well-established safety data. This creates the conditions for a more efficient development process compared with many traditional drug development programmes, says Janne Backman, Chairman of the Board of Sobrera Pharma.

The company is also experiencing growing international interest from clinical experts, investors, and potential strategic partners.

– We are currently in an exciting phase with increasing international interest, and we look forward to the next stage of our journey, concludes Ann-Charlotte Rosendahl.

About SO-001: SO-001 is an investigational drug candidate currently in clinical development. It has not been approved by any medicines regulatory authority and may not be prescribed, used, or marketed for the treatment of Alcohol Use Disorder. The information presented in this article is intended for general informational purposes only and does not constitute promotion of a medicinal product under the Swedish Medicinal Products Act (2015:315) or the Ethical Rules for the Pharmaceutical Industry (LER).