French Biotech Candidate For Cannabis Use Disorder Fails Phase 2B Clinical Trial, Indivior Will Not Exercise Option

French biotechnology company specializing in the treatment of brain disorders Aelis Farma reported Wednesday the results from its clinical Phase 2B trial with AEF0117, evaluating the efficacy and safety in treatment-seeking participants with moderate to severe cannabis use disorder (CUD).

The study did not meet its main goal, which was to reduce participants' cannabis use to one day or less per week. It also failed to meet other goals, such as getting participants to stop using marijuana completely or reduce their consumption to two days or less per week.

"It is noteworthy that there was a very low placebo effect for these endpoints, suggesting that CUD participants in this study may be resistant to change the number of days per week of use," Aelis Farma said in a press release.

AEF0117 was well tolerated, and no safety concerns were observed. The type and frequency of adverse events were similar across all treatment groups including placebo.

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Indivior Rethinks Exercising Option

This clinical Phase 2B study is part of the strategic collaboration between Aelis Farma and Indivior PLC INDV, which includes an exclusive option for Indivior to license the global rights to AEF0117. Following the results announcement, the U.K.-basedglobal pharmaceutical company focused on developing medicines to treat substance use disorders (SUD) and serious mental illnesses provided an update on the option.

"Given the lack of separation from placebo on primary and secondary endpoints and before seeing further additional favorable clinical data, Indivior does not currently expect to exercise its option," Indivior stated.

In 2021, Indivior and Aelis Farma announced a strategic collaboration that includes an exclusive option and license agreement for the global rights to AEF0117, a first-in-class synthetic signaling specific inhibitor engineered to inhibit the cannabinoid type 1 receptor. Indivior paid $30 million for the option to license the candidate.

Price Action

Indivior shares traded down 0.25% at $12.14 per share at market close Wednesday.

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