- 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.
Loading...
Loading...
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
