Merck to Begin New Phase 3 Trial for Islatravir HIV-1 Treatment
20 September 2022 - 1:42PM
Dow Jones News
By Chris Wack
Merck & Co. said Tuesday it will begin a new Phase 3
clinical program with once-daily islatravir for the treatment of
people with HIV-1 infection.
The company said these new Phase 3 studies will evaluate a
once-daily oral combination of doravirine 100 mg and a lower dose
of islatravir, known as 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 in adults with HIV-1 infection who
are virologically suppressed, the company said.
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, it
said.
The U.S. Food and Drug Administration has reviewed and agreed
with this plan. The investigational new-drug application 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 company
said.
Merck said it will discontinue the development of once-monthly
oral islatravir for pre-exposure prophylaxis. Participants in the
ongoing Phase 3 PrEP once-monthly oral studies will continue to be
monitored. A Phase 1b study in adults with HIV-1 infection
assessing MK-8527, a novel nucleoside reverse transcriptase
translocation inhibitor, or NRTTI, candidate, will begin soon, the
company said.
Merck also said the Phase 2 clinical trial evaluating an
investigational oral once-weekly combination treatment regimen of
islatravir and Gilead Sciences Inc.'s lenacapavir in adults with
HIV-1 infection who are virologically suppressed will resume under
an amended protocol with a lower dose of islatravir.
The IND under which the islatravir-plus-lenacapavir once-weekly
treatment regimen is being investigated 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, the company said.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 20, 2022 07:27 ET (11:27 GMT)
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