Sen-Jam Pharmaceutical, based in New York, has commenced a Phase II clinical trial to assess the efficacy of its hangover prevention treatment, SJP-001. The trial, taking place in Australia, will investigate the compound's ability to mitigate hangover symptoms following alcohol consumption.
SJP-001 is a combination therapy containing naproxen and fexofenadine, designed to target the inflammatory response believed to be the primary driver of hangover symptoms. Pre-clinical studies have indicated that SJP-001 can reduce both the severity and duration of these symptoms.
Prior Research and FDA Approval
Sen-Jam previously obtained an FDA Investigational New Drug Application (IND) to initiate Phase I and II clinical trials. This followed a pilot study published in the Journal of Clinical Medicine in 2020, which demonstrated that SJP-001 significantly reduced hangover severity compared to placebo. The study highlighted improvements in symptoms such as thirst, headache, dizziness, and nausea.
Addressing a Significant Economic Burden
According to the US Center for Disease Control, excessive drinking cost the United States an estimated $249 billion in 2010. This translates to approximately $2.05 in economic costs for every alcoholic drink consumed, highlighting the substantial economic impact of alcohol-related issues.
Innovative Funding Approach
The Phase II trial is notable for its partially crowdfunded nature. Sen-Jam is financing the trial through the sale of fractional royalty rights in the product and its patent portfolio. This approach allows individuals to support the development of SJP-001 while potentially receiving financial returns.
Management Perspective
Jim Iversen, CEO of Sen-Jam Pharmaceutical, stated that the fractional royalty rights offering allows people to directly support innovation while creating an opportunity for financial returns. He also mentioned that this enables them to return capital to their investors soon after licensing deals are in place.
Jackie Iversen, co-founder and chief clinical officer at Sen-Jam Pharmaceutical, emphasized that their approach is grounded in cutting-edge international research that has identified inflammation as the primary driver of these alcohol-related symptoms.
Competitive Landscape
Other companies are also exploring treatments for alcohol-related disorders. Imbrium Therapeutics has submitted an IND for a Phase II clinical trial of Sunobinop for moderate to severe alcohol use disorder (AUD). Additionally, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) awarded a $2 million grant to Amygdala Neurosciences to support an IND for an aldehyde dehydrogenase (ALDH2) inhibitor for AUD treatment.
