Merck Presents Results from Phase 1 Trial Evaluating Investigational Islatravir Subdermal Implant for the Prevention of HIV-1 Infection at CROI 2021
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from a Phase 1 study evaluating the safety, tolerability and pharmacokinetics (PK) of the company’s investigational subdermal drug-eluting implant with potential for extended administration of islatravir for pre-exposure prophylaxis (PrEP) of HIV-1 infection. Islatravir is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated across a variety of doses, formulations and frequencies for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a single agent. Study results, presented as a late-breaking oral presentation [Presentation 88] at the 2021 Conference on Retroviruses and Opportunistic Infections (CROI 2021), demonstrate that the implant achieved active drug concentrations above the pre-specified PK threshold at 12 weeks across the three doses of islatravir studied (48 mg, 52 mg and 56 mg), and is projected to provide drug concentrations likely above threshold for one year at the 56 mg dose. Based on these findings, Merck plans to initiate a Phase 2 trial to further explore the potential of a subdermal implant containing islatravir as a long-acting option for PrEP for up to 12 months.
“We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “We know that PrEP can have a positive impact in curbing the spread of HIV and are looking forward to evaluating our implant further with the goal of developing new long-term options for HIV prevention.”
Phase 1 Implant Study Results for Investigational Anti-HIV agent Islatravir
The Phase 1 double-blind, placebo-controlled trial evaluated the safety, tolerability and PK of islatravir administered using a drug-eluting implant placed subdermally in healthy participants. People in the study received an implant containing islatravir at doses of either 48 mg (n=8), 52 mg (n=8), 56 mg (n=8) or placebo (n=12; 4 in each dose level). After 12 weeks, the implant was removed, and participants were evaluated for an additional eight weeks.
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