Charlottesville-based Adial Pharmaceuticals, a spin-off company from the University, is developing a drug to treat alcoholism in subjects with certain genetic makeups. Founded in 2011 at the University by Bankole Johnson, William Stilley and Joseph Truluck, Adial plans to begin Phase 3 of clinical trial testing for their drug as of Fall 2018.
According to the , society often views alcoholism as a choice — with strong doses of self-control and discipline often prescribed as its treatment. Those inside the medical community may be hesitant to treat it as a disease. FAR says that many medical professionals still only see diseases as something that can be “caught” or “spread.”
With the dawn of precision medicine, researchers are finding evidence that alcoholism is genetically linked. Johnson — chair of the Department of Psychiatry at the University of Maryland and previous chair of the Department of Psychiatry and Neurobehavioral Sciences at U.Va. — whose research uses the concept of precision medicine to find treatments for alcoholism, explains that precision medicine is all about targeting treatment to the individual. According to Johnson, about a third of the population possesses genetic predispositions such that their alcoholism can be treated with a simple pill.
Through Johnson’s prior genetic profiling research at the University, he found that about a third of us have a “genotypic patent” — or genetic pattern — that causes certain genes to become overexpressed when we drink, causing excessive levels of the chemical serotonin to be released.
Serotonin itself is not problematic. According to Medical News Today, it is the feel-good chemical of the brain; we need it to be productive, to feel happy, to form healthy relationships. What can be problematic, however, is when it is released into the body along with drinking alcohol, leading to drinkers to associate alcohol with pleasure. And for that third of the population, this pleasure is especially intense and can lead to alcoholism as a result.
Following 15 years of research, Johnson identified a drug — AD04 — that blocks this serotonin when taken at very low dose. Any higher dose, Johnson said, would be ineffective, even detrimental to patients.
Johnson said prescribing this drug will work much like prescribing insulin to a diabetes patient. Those struggling with alcohol abuse will see their doctor, receive blood tests to determine if they have the genotypic patent, begin taking the drug at low doses if they have the patent and continue to see their doctor once a week for check-ins. According to Johnson, the process is a simple one and has the potential to be accessible for most patients.
George Bloom, professor and chair of the Department of Biology, also recognized the accessibility of this drug. “Very routine lab work” is all it would take to determine if a patient has the genetic patent, Bloom said.
Adial Pharmaceuticals is capitalizing on this accessibility. Through collaboration with Johnson and the University, Adial is now in its third phase of FDA testing so that it can produce AD04 for public use.
Stilley, Adial CEO and Darden School alumnus, said the company received Initial Public Offering status back in July of this year, which means shares of Adial can be sold to investors on the stock market. Stilley hopes Adial will ameliorate the impacts of alcoholism.
“I love the pharmaceutical industry because you are always working for a higher purpose,” Stilley said.
According to Stilley, more than 35 million people in the United States suffer from alcoholism, which is the leading cause of death for those aged 15 to 40. If Adial continues to see significant data in the third phase of FDA testing as they did in the second, Stilley believes the drug can hit the market as soon as about a year from now.
Moreover, beyond AD04, Stilley plans to use precision medicine to expand into treatments for other addictions.
Bloom sees the potential for expansion as well. According to Bloom, that the science behind AD04 can be applied to other addictions, like opioid addictions.
To Johnson, the drug will reduce the stigma of addiction. He believes the process of genetic profiling and prescribing AD04 will remind society that alcoholism — and other addictions — are diseases, with corresponding genetic profiles to match.