Merck to start new late-stage studies of investigational HIV drug with a lower dose


U.S. pharma major Merck (NYSE:MRK) on Tuesday said it would start new phase 3 clinical studies with its investigational HIV drug islatravir, more than six months after the U.S. FDA placed the trials on hold.

The regulatory agency in Dec. last year had placed Merck’s (MRK) investigational new drug applications for islatravir on hold, citing decreases in total lymphocyte and T-cell counts in some patients who were taking the treatment in trials.

MRK had also put on hold a phase 2 trial assessing islatravir in combination with Gilead Sciences’ (GILD) lenacapavir.

In Tuesday’s statement, Merck (MRK) said the mid-stage study with GILD’s lenacapavir would resume with a lower dose of islatravir.

The company also decided to discontinue the development of a monthly oral dose of islatravir for pre-exposure prophylaxis.

The new late-stage trials with islatravir will evaluate a lower dose of the drug in combination with Merck’s (MRK) other HIV treatment doravirine.

One study will evaluate the doravirine/islatravir combination in previously untreated adults with HIV-1 infection and two studies will evaluate the combination as a switch in antiretroviral therapy in adults with HIV-1 infection who are virologically suppressed, MRK said.

The U.S. FDA had reviewed and agreed to the plans for the new late-stage clinical program.

MRK also said a phase 1b study in adults with HIV-1 infection assessing its inhibitor MK-8527 will start soon.

MRK stock -0.5% to $86.21 in morning trading.

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