Merck’s monthly oral HIV drug Phase 2a clinical results are positive

Merck’s monthly oral HIV drug Phase 2a clinical results are positive.  As a PrEP drug, this randomized, double-blind, parallel-group, placebo-controlled, multi-center Phase 2a clinical trial is conducted in adults with a lower risk of HIV-1 infection.

On January 26, 2021, Merck announced the latest interim data of its Phase 2a clinical trial (NCT04003103). The study evaluated the safety, tolerability and medication of monthly islatravir oral tablets for pre-exposure prophylaxis (PrEP). Generation Kinetics (PK). The results of the interim study showed that both doses of islatravir (60 mg and 120 mg) reached the preset effective PK threshold for PrEP and were acceptable tolerable.

Islatravir is a nucleoside reverse transcriptase translocation inhibitor (NRTTI) under development. In addition to pre-exposure prophylaxis (PrEP) for HIV-1 infection, Merck is also evaluating the combination of this drug with other antiretroviral drugs. It is used to treat HIV-1 infection, including the once-daily clinical trial ILLUMINATE.

As a PrEP drug, this randomized, double-blind, parallel-group, placebo-controlled, multicenter Phase 2a clinical trial was conducted in adults with a lower risk of HIV-1 infection, and subjects were randomly assigned (2:2: 1) To three oral treatment groups once a month: islatravir 60mg, islatravir 120mg or placebo. During the 24-week blinding treatment period, subjects receive islatravir or placebo once a month, followed by a 12-week blinding phase (after which the sponsor will unblind for an interim assessment of safety), and A 32-week unblinded follow-up in the islatravir treatment group to characterize the terminal elimination period.

During the interim data analysis, 76.8% (n=192/250) of the planned subjects had been randomized and administered. Of these subjects, 32.8% (n=63/192) were male, 67.2% (n=129/192) were female, 30.2% (n=58/192) were black or African American, and 16.1% ( n=31/192) is Hispanic or Latino. Most adverse events (AE) were mild or moderate, and the most common (reported by> 4% of subjects) included headache (7.3%), diarrhea (5.7%), nausea (4.7%), abdominal pain (4.2%) ) And upper respiratory tract infection (4.2%). Due to categorized as possible drug-related AEs, including foreign body sensation in the throat (mild), rash, and itching (moderate), two subjects discontinued treatment.

Interim PK analysis of islatravir triphosphate (active form of islatravir) in peripheral blood mononuclear cells (PBMC) showed that the minimum concentration between two doses was still higher than the preset for preventing HIV-1 infection, regardless of the 60 mg or 120 mg dose PK threshold (0.05 pmol/106 PBMC). The PK of Islatravir showed approximately linear dose ratios at the two study doses. Preliminary PK analysis of mucosal tissues (rectum, cervix and/or vagina) of a part of subjects (n=54) showed that islatravir can be quickly and continuously distributed into the sampled tissues. This ongoing Phase 2a study has been recruited, and the preliminary analysis of the entire data set is expected to be completed in the second half of 2021.

(source:internet, reference only)

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