NEW YORK – Adial Pharmaceuticals this week announced it has entered into an agreement with Boudicca Dx, which provides consulting services for precision medicine testing, to develop its regulatory strategy for the companion diagnostic for its AD04 drug candidate.
Boudicca Dx will advise the biopharma company as it refines a regulatory strategy for the genetic test it plans to submit for approval with the US Food and Drug Administration as a companion diagnostic for AD04, a genetically targeted drug it's developing as a treatment for alcohol use disorder (AUD).
AD04 is an oral medication that targets a specific set of genetic variants related to serotonin that Adial says is present in about 20 percent of patients with AUD. AD04 blocks serotonin-3 receptors to inhibit the dopamine reward system that's activated by alcohol, which could reduce cravings for these patients.
Adial believes that, in AUD patients with this genetic makeup who are considered heavy drinkers, AD04 can reduce binge drinking. Heavy drinking is defined as fewer than 10 drinks per drinking day.
Boudicca Dx will work with Glen Allen, Virginia-based Adial to ensure the companion diagnostic test is validated technically and clinically in compliance with FDA guidelines.
Adial previously tested AD04 in a broader population of drinkers in the Phase III ONWARD trial, but the drug missed its primary endpoint of significantly reducing heavy drinking days. However, the company determined that the drug showed promising results among the subset of patients with heavy drinking and certain genetic variants, which it has decided to home in on in a new Phase III trial.
Adial last week said it dosed the final patient in an open-label pharmacokinetics clinical trial of AD04 in healthy volunteers, top-line results of which are expected to be reported during Q4. The company said it will use these results in discussions with the FDA to seek feedback on the design of a Phase III trial.
"As we continue to prepare for the Phase III study for AD04, this agreement with Boudicca Dx is another key component toward achieving clinical success and is expected to support our next FDA interaction," Adial President and CEO Cary Claiborne said in a statement. He said Adial will also work with Boudicca Dx to develop a commercial strategy for the genetic test.
Separately, Adial has said it believes AD04 could be a treatment for other addictive disorders such as opioid use disorder, gambling, and obesity.