Adial at a clinical fork in the road after flunking phase 3 trial for its alcohol addiction med

Adial Pharmaceuticals failed the primary goal of a phase 3 trial of its alcohol use disorder treatment, but its CEO told Fierce Biotech the company had accrued enough encouraging data that it still intends to march to regulators for feedback. 

Data from the trial found that the treatment, AD04, did not significantly lessen drinking compared to placebo among heavy drinkers and very heavy drinkers, the primary endpoint of the trial. That was due in large part to a significant reduction in drinking among the placebo group in very heavy drinkers, defined as individuals who average 10 drinks per drinking day. 

But, when separated out, heavy drinkers—not including very heavy drinkers—were found to have a statistically meaningful 79% reduction in drinking. That’s also the population that Adial estimates would make up the majority of people taking the treatment.

No serious side effects or cardiac events were identified among the treated group, the latter of which was specifically mentioned by regulators at the end of phase 2 as an adverse event to monitor for. 

Evidently, that’s enough for Adial to tie a bow around the results and present them to both U.S. and European regulators, with the goal of still nabbing approval. But CEO William Stilley is not naive about the other options on the table given that the trial ultimately didn’t hit its intended mark. 

“We don’t get to play God on this; the regulators do,” he told Fierce in an interview. “So they will tell us what needs to happen.” Stilley said that in his mind, the worst-case scenario would be a request for two additional phase 3 trials, and a reasonable outcome would be for one more.

The prospect of more clinical development is daunting for a company that at the end of the first quarter reported just more than $12 million on hand, though Stilley said, if need be, the company is equipped to do that. However, building up a commercial operation is a much more daunting task, especially overseas, prompting the company to pursue partnerships.

“To get the full impact of the drug, you would really want somebody that has the capability to do direct consumer marketing, which would not be a small company,” said Stilley, who added there are a “number of companies that could potentially be partners” on AD04. 

Stilley’s confidence is based firmly in the potential cash windfall, with Adial estimating that alcohol use disorder represents a $36 billion market. The company is considering charging $255 a month wholesale for the treatment, but Stilley is optimistic that given how alcohol abuse translates to other diseases, payers could be lining up to buy it. 

Overall, the CEO considers this a win but concedes the primary endpoint may not have been the most ideal. 

“Maybe we didn't design the primary efficacy analysis appropriately given all the things that go on in a trial like this, but it does seem to have an effect,” he said. “And that means that we have … an obligation to get this into the hands of patients, and we're going to take those next steps.”