Aelis Farma, a French biotechnology company specializing in brain disorders, announced that its Phase 2B clinical trial of AEF0117 for cannabis use disorder (CUD) did not meet its primary endpoint. The trial aimed to evaluate the efficacy and safety of AEF0117 in participants seeking treatment for moderate to severe CUD.
The study's primary goal was to reduce participants' cannabis use to one day or less per week. Secondary endpoints included complete cessation of marijuana use and reduction of use to two days or less per week. Aelis Farma reported that AEF0117 failed to demonstrate a statistically significant difference compared to placebo in achieving these endpoints.
According to Aelis Farma, the placebo effect observed in the trial was notably low, suggesting that participants with CUD in this study may have been resistant to changing their frequency of cannabis use. Despite the lack of efficacy, AEF0117 was well-tolerated, with the frequency and type of adverse events being similar across all treatment groups, including the placebo group.
Indivior's Decision
The Phase 2B trial was part of a strategic collaboration between Aelis Farma and Indivior PLC, a pharmaceutical company focused on substance use disorders (SUD) and serious mental illnesses. The collaboration included an exclusive option for Indivior to license the global rights to AEF0117. Following the announcement of the trial results, Indivior stated that it does not currently expect to exercise its option, citing the lack of separation from placebo on both primary and secondary endpoints. Indivior had paid $30 million for the option to license the candidate in 2021.
About AEF0117
AEF0117 is a first-in-class synthetic signaling specific inhibitor engineered to inhibit the cannabinoid type 1 receptor (CB1). The drug was being developed as a potential treatment for cannabis-related disorders. The failure of the Phase 2B trial raises questions about the future development of AEF0117 for CUD.
