Merck To Start New Islatravir HIV Trials With Lower Dose After FDA Hold

Merck & Co Inc MRK will initiate a new Phase 3 program with once-daily islatravir to treat people with HIV-1 infection.
These new Phase 3 studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL).
One study will evaluate DOR/ISL in previously untreated adults with HIV-1 infection, and two studies will evaluate DOR/ISL as a switch in antiretroviral therapy (ART) in adults with HIV-1 infection virologically suppressed.
Certain study participants currently enrolled in once-daily treatment studies with DOR 100 mg/ISL 0.75 mg will have the option of transitioning to a new study with the lower islatravir dose.
The FDA has reviewed and agreed with this plan.
The investigational new drug application (IND) for the once-daily oral DOR/ISL treatment program remains under a partial clinical hold for any studies that would use doses higher than the dose to be studied in the new Phase 3 program.
The Phase 2 trial evaluating an oral once-weekly combination of islatravir and Gilead Sciences Inc's GILD lenacapavir in virologically suppressed adults with HIV-1 infection will resume under an amended protocol with a lower dose of islatravir.
The IND under which the islatravir + lenacapavir once-weekly treatment regimen remains under a partial clinical hold for any studies that would use weekly oral islatravir doses higher than the doses considered for the revised clinical program.
Additionally, Merck will discontinue the development of once-monthly oral islatravir for preventing HIV infection.
Price Action: MRK shares are down 0.61% at $86.11 on the last check Tuesday.

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