Sobrera Pharma: New treatment strategy reduces alcohol consumption

Two existing medications with complementary effect on dopamin - varenicline and bupropion - show in a study a statistically significant reduction in alcohol consumption in the patient population. The result has recently been published in The Lancet Regional Health – Europe. The clinical trial has been led by Bo Söderpalm, professor of psychiatry at the Sahlgrenska Academy, University of Gothenburg, and senior physician at Sahlgrenska University Hospital, together with Andrea de Bejczy, PhD researcher affiliated with the Sahlgrenska Academy and resident physician at Sahlgrenska University Hospital.

Alcohol Use Disorder (AUD) is a common chronic disorder that is estimated to account for about five percent of the global disease burden and shorten the lives of those with severe forms of the disorder by 25 years or more.

Sobrera Pharma AB is a Swedish pharmaceutical company developing therapies for treatment and prevention of AUD. Sobrera Pharma´s CEO Ann-Charlotte Rosendahl comments the promising result:

“Despite the high occurrence, significant unmet medical needs exist in the management of AUD. Our expectation is that the development of a new pharmaceutical treatment strategy has the potential to make everyday life better for all those suffering directly and indirectly from AUD,” says Sobrera Pharma´s CEO Ann-Charlotte Rosendahl.

The result of the study introduces a new treatment strategy: boosting dopamine levels in the brain. The researchers have based their approach on the hypothesis that a dopamine deficiency drives the craving for alcohol. To enhance dopamine signaling they combined varenicline, which stimulates dopamine release via nicotine receptors, with bupropion, which helps the brain maintain dopamine levels after release.

A total of 384 individuals with moderate to severe alcohol use disorder took part in the 13-week study at four alcohol clinical research sites in Sweden. Participants were randomly assigned to one of four groups, receiving either the combination treatment, one of the two drugs alone, or a placebo. Neither the participants nor the researchers knew who received what during the trial.

The result of the clinical trial shows that the combination reduces alcohol cravings, lowers consumption, and may decrease the risk of nausea. The greatest reduction in alcohol consumption occurs among those who received the combination therapy. Varenicline alone also produced a measurable effect. The outcome was assessed using both blood biomarkers (B-PEth, which indicates whether a person has consumed alcohol regularly over the past few weeks) and self-reporting.

“We observed a higher effect compared to currently available medications, which is highly promising. However, additional studies are required before the combination treatment can be approved for alcohol use disorder,” says professor Bo Söderpalm.

“Nausea is a well-known and troublesome side effect of treatment with varenicline. It was surprising but very encouraging to see that nausea decreased when bupropion was added. The fact that the combination treatment is more tolerable for patients increases the chances that they will complete the full course of treatment,” says Andrea de Bejczy, affiliated to research.

Efficacy and safety of varenicline and bupropion, in combination and alone, for alcohol use disorder: a randomized, double-blind, placebo-controlled multicentre trial
The Lancet Regional Health – Europe

About Alcohol Use Disorder

Alcohol Use Disorder (AUD) is a chronic relapsing brain disease characterized by compulsive use of alcohol and the inability to control intake. It is a common and serious health issue globally, and a major cause of morbidity and mortality. AUD is the third leading preventable cause of death in the United States, and according to the World Health Organization, harmful use of alcohol is responsible for 5.1% of the global burden of disease (1,2). There is a great need for new and improved treatments to help people suffering from AUD.

1. National Institute on Alcohol Abuse and Alcoholism. Click link here https://www.niaaa.nih.gov/

2. World Health Organization. Click link here https://www.who.int/

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About Sobrera Pharma AB

Sobrera Pharma AB is a clinical-stage pharmaceutical company focused on the development of new treatments for patients with substance use disorders. The Company is focusing initially on the product in development, SO-001 for Alcohol Use Disorder (AUD). Sobrera’s vision is to offer an effective and easy-to-use treatment to improve health and quality of life and to reduce the risk of morbidity and premature death in patients with AUD. The company is headquartered in Gothenburg, Sweden.

More information at: www.sobrera.com

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Contact:

Ann-Charlotte Rosendahl, CEO Sobrera Pharma AB

Email: ann-charlotte.rosendahl@sobrera.com

Phone: +46 (0)732 096 405

Bo Söderpalm, professor of psychiatry at the Sahlgrenska Academy, University of Gothenburg, and senior physician at Sahlgrenska University Hospital, Sweden

Email: bo.soderpalm@neuro.gu.se

Andrea de Bejczy, PhD researcher affiliated with the Sahlgrenska Academy and resident physician at Sahlgrenska University Hospital, Sweden

Email: andrea.debejczy@neuro.gu.se