Safety Signals Force Merck and Enanta to Stop HIV and HBV Programs

Safety Signals Force Merck and Enanta to Stop HIV and HBV Programs

Merck and Enanta Pharmaceuticals released updates on their HIV and HBV programs, respectively. Merck was evaluating MK-8507 in a phase 2 trial and Enanta was evaluating EDP-721 in a phase 1 trial. Both trials showed emerging safety observations deemed serious enough to stop development. 

Merck’s Phase 2 IMAGINE-DR clinical trial (MK-8507-13) was designed to evaluate the combination of MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, as a once-weekly oral treatment for HIV-1 infection. Decreases in total lymphocyte and CD4+ T-cell counts were observed in study patients randomized to receive ISL+MK-8507. A review by the external Data Monitoring Committee determined that this effect was related to treatment with the combination of ISL+MK-8507; the greatest decreases were seen in the arms of the study receiving the highest doses of MK-8507 (200 mg and 400 mg). At the recommendation of the committee, Merck halted dosing in the trial and will continue to monitor all 161 study participants.

Enanta was evaluating EDP-721, an oral HBV RNA destabilizer, in a phase 1 single ascending dose trial ...

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