Adial taps Finnish CRO Crown for phase 3 trial of alcohol abuse treatment

Man saying no to alcohol
The 24-week trial with 290 patients is expected to begin in the first half of next year. (GeorgeRudy/iStock/Getty Images Plus)

Addiction drug developer Adial Pharmaceutical has tapped Finnish CRO Crown to manage phase 3 trials for the company’s AD04 designed for the treatment of alcohol use disorder (AUD).

The FDA has approved the protocol for a 24-week trial with 290 patients expected to begin in the first half of next year. Five sites throughout Europe have been designated for the trial, the company said.

The investigational new drug candidate is a genetically targeted therapeutic agent aimed at treating AUD. In a phase 2b trial, the treatment showed promising results in reducing the frequency of drinking, quantity of drinking and heavy drinking with no overt safety concerns.

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“The alcohol addiction market is dramatically underserved with very limited and often ineffective options for patents,” Tarja Leikas, Crown’s chief executive, said in a statement. “Given the prevalence of alcohol use disorder and the targeted genotype for AD04, we expect to be able to leverage our geographic expertise, especially within Scandinavia and Eastern Europe, to rapidly enroll patients while effectively managing costs.”

Leikas estimates that more than 55 million people in Europe alone suffer from AUD.