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

  • Merck & Co Inc (NYSE: 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 (NASDAQ: 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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