Press release: Both primary endpoints successfully met in Phase 2 trial for patients with Alcohol Use Disorder (AUD)
Sobrera Pharma AB, a Swedish pharmaceutical company developing therapies for treatment and prevention of Alcohol Use Disorder (AUD), today announced successful results from a Phase 2 trial conducted by the Addiction Biology Unit, University of Gothenburg, Sweden. The study has evaluated the efficacy, safety and tolerability of a combination of varenicline and bupropion vs. placebo for patients with moderate to severe AUD. The study showed a statistically significant reduction in alcohol consumption in the patient population based on the outcome of both the primary variables: the objective alcohol biomarker phosphatidylethanol (B-PEth) and self-reported heavy drinking days.
The Phase 2 trial has given proof that this new and innovative concept to combine varenicline and bupropion to treat AUD, is effective. Sobrera Pharma intends to share the results with relevant regulatory authorities to discuss and consult around the appropriate next steps towards the development of a new treatment for AUD.
This randomized, double-blind, placebo-controlled, 13-week, multi-centre Phase 2 clinical trial with four parallel arms enrolled 384 patients with moderate to severe AUD. It was designed to evaluate the efficacy and safety of two substances that raise dopamine levels in the brain, varenicline and bupropion, alone and in combination vs. placebo for alcohol reduction in patients with AUD.
The investigator initiated clinical trial was conducted at four alcohol clinical research sites in Sweden, by Professor Bo Söderpalm, sponsor and principal investigator, and Senior Researcher Andrea de Bejczy at Addiction Biology Unit, University of Gothenburg, Sweden.
Highlights of topline data showed that:
- The combination of varenicline and bupropion during a treatment period of 13 weeks significantly (p=0.004) reduced levels of alcohol biomarker phosphatidyethanol (B-PEth) in blood compared to placebo.
- The combination of varenicline and bupropion during a treatment period of 13 weeks significantly (p=0.008) reduced proportion of heavy drinking days compared to placebo.
The full results of this Phase 2 trial are planned to be presented towards the end of 2023, or early 2024.
Ann-Charlotte Rosendahl, Chief Executive Officer of Sobrera Pharma, commenting on the trial results, says:
”Alcohol Use Disorder is a common chronic disorder that is estimated to account for about 5 percent of the global disease burden. Despite the high occurrence, significant unmet medical needs exist in the management of AUD. With the promising results from the Phase 2 clinical trial study, we intend to engage with relevant regulatory authorities to discuss and consult on the appropriate next steps in the product development.”
“I am hopeful that the development of a new pharmaceutical treatment option has the potential to make everyday life better for all those suffering directly and indirectly from AUD,” says Sobrera Pharma CEO Ann-Charlotte Rosendahl.
Bo Söderpalm, Professor at Addiction Biology Unit at the University of Gothenburg and the Principal Investigator of the trial, says:
“After many years of basic research and clinical work in the AUD and dopamine area, we now have proof of this new concept of combining varenicline and bupropion for treatment of AUD. Both these substances are well documented in their ability to raise dopamine levels, and we believe that they act complementary to restore depleted levels of dopamine in the brain’s reward system and thereby reduce alcohol intake. I am confident that this promising new treatment for reducing alcohol intake has the potential to be more effective than current medical treatments and offers a significant advance in healthcare for our patients.”
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.
- National Institute on Alcohol Abuse and Alcoholism. Click link here
- World Health Organization. Click link here
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 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, to reduce the risk of morbidity and premature death in patients with AUD, and to reduce the related societal costs by doing so. The company is headquartered in Gothenburg, Sweden.
More information at: www.sobrera.com
Ann-Charlotte Rosendahl, CEO Sobrera Pharma AB
Phone: +46 (0)732 096 405
Professor Bo Söderpalm, Addiction Biology Unit, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden
Phone: +46 (0)31 342 4724
Senior Researcher Andrea de Bejczy, Addiction Biology Unit, Institute of Neuroscience and Physiology, University of Gothenburg, Sweden
Phone: +46 (0)31 342 4724