NEW YORK (GenomeWeb) — Adial Pharmaceuticals said today that it has signed on Eurofins Scientific to help validate a companion diagnostic for its alcohol use disorder drug AD04 and identify patients for enrollment in a Phase III trial.
AD04 is a formulation of the antinausea drug Zofran (ondansetron), which blocks the serotonin receptor 5-HT3. According to Charlottesville, Virginia-based Adial, the drug can prevent the ethanol-stimulated release of dopamine in certain subgroups of the alcohol-dependent population, and it has developed a genetic companion diagnostic to identify such individuals.
Under the terms of the deal, Luxembourg-based Eurofins will transfer the test's methodology into its facilities and perform the laboratory validation of the companion diagnostic using qPCR. Eurofins will also test potential study participants prior to their enrollment to determine if they have the genetic markers indicating they would likely respond to treatment. Only patients positive for the markers will be included in the trial, Adial said.
Additional terms were not disclosed.
"Our investigational product, AD04, uses a novel mode of action designed to reduce cravings for alcohol to effectively curb alcohol intake, without the requirement of abstinence prior to or during treatment," Adial President and CEO William Stilley said in a statement. "Genetically prescreening patients prior to enrollment ... is expected to dramatically enhance the efficacy rates of AD04 in the trial and reduce the time and cost needed to conduct the trial."