Merck announced a Phase I study evaluating the pharmacokinetics and safety of a prototype subdermal drug-eluting implant for extending administration of islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), in healthy volunteers.
The prototype’s early findings were presented as a late-breaking oral presentation (Abstract TUAC0401LB) at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City.
What is Islatravir?
Also known as “MK-8591,” islatravir is an investigational drug for the treatment of HIV infection. Classified as a nucleoside reverse transcriptase translocation inhibitor (NRTTI), Merck is the drug developer behind this subdermal drug-eluting implant to administer the investigational therapy.
The investigational treatment has been evaluated against HIV in animal models and is being studied clinically for HIV treatment and prophylaxis. Islatravir is a nucleoside analog reverse transcriptase inhibitor that unlike other such inhibitors, inhibits HIV through multiple mechanisms, offering fast suppression of the virus when tested in primates and mice. Nevertheless, there are HIV strains resistant to islatravir and research is ongoing.
Merck is conducting a broad development program to evaluate the potential of islatravir for the treatment and prevention of HIV-1 infection. The lead program in treatment of HIV-1 infection is assessing a once-daily, oral, 2-drug regimen based on Merck’s press release. The sponsor is also exploring several potential options for PrEP, including a drug-eluting implant and once-monthly formulation.
Merck plans to initiate a Phase 2 double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of investigational oral islatravir taken once-monthly by participants at low-risk for HIV-1 infection. The trial will commence recruitment in September, 2019.
The Phase 2 Clinical Trial
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of two doses of oral MK- 8591 compared with placebo in adults at low risk of HIV-1 infection. Merck seeks to recruit 250 participants. The study planned end date is April, 2021.