Aelis' Cannabis Drug Fails Phase 2b, Indivior Rethinks $100M Option

Aelis Farma has faced a setback in its attempt to advance a promising treatment for cannabis use disorder (CUD). The French biotechnology company recently announced that its phase 2b clinical trial for its candidate, AEF0117, did not meet the primary and secondary endpoints. This development has also affected the company's partnership with Indivior, a British pharmaceutical firm that had previously invested $30 million for the option to license AEF0117.

In 2021, Indivior secured an option to license AEF0117, a specialized inhibitor that targets the cannabinoid receptor 1 (CB1). The goal was to determine its efficacy in treating CUD. The plan was for Indivior to make its final decision after evaluating phase 2b clinical data and receiving feedback from the U.S. Food and Drug Administration (FDA) regarding the clinical endpoints for future studies. However, the disappointing results from the phase 2b trial prompted Indivior to reconsider its options even before obtaining the FDA's input.

Aelis Farma's phase 2b study involved 333 participants who were actively seeking treatment for moderate to severe CUD. These individuals were randomized to receive one of three doses of AEF0117 or a placebo over a 12-week period. At the beginning of the trial, all participants used cannabis at least five days per week. The primary endpoint was to reduce cannabis use to one day per week, but AEF0117 showed no significant improvement over the placebo. Secondary endpoints, which included the proportion of participants who completely abstained or reduced their usage to two days per week, were also not met.

While Aelis Farma has not yet disclosed detailed figures, they indicated that there was a very low placebo effect for these endpoints. This observation implies minimal improvement in the treatment arms, challenging the hypothesis that selectively blocking CB1 could decrease cannabis use by inhibiting the signaling pathways responsible for its intoxicating effects.

The only positive aspects reported were related to safety and tolerability, which were comparable between the treatment and placebo groups. Additionally, there were some "consistent positive trends" noted in the highest dose group for secondary endpoints, particularly in terms of the total amount of cannabis used, and some near-statistically significant effects were observed concerning anxiety, depression, and sleep quality. However, these findings were more pronounced in participants with moderate CUD, a smaller subgroup since 82% of the study participants had severe CUD.

Following the trial’s outcome, Aelis Farma is reviewing the data and has not yet made a decision on the next steps for AEF0117. Indivior, on the other hand, has indicated that it does not currently plan to exercise its option to license the candidate but has not entirely ruled out the possibility. Favorable clinical data in the future might influence Indivior's final decision.

As it stands, the future of AEF0117 remains uncertain. Both companies are closely evaluating their positions in light of the recent clinical trial results, and further developments will depend on a more detailed analysis of the data and potential regulatory feedback.

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