MSD has announced results from a Phase I study evaluating the pharmacokinetics and safety of a prototype subdermal drug-eluting implant for islatravir, an antiretroviral therapeutic for the prevention and treatment of HIV.
The investigational drug is a nucleoside reverse transcriptase translocation inhibitor (NRTTI), and MSD is currently conducting a broad development program to evaluate the potential of the therapy for the treatment and prevention of HIV-1 infection.
The Phase I double-blind, placebo-controlled study found that the implant containing 62mg of the drug was estimated to deliver levels well above the threshold at 12 months, providing early evidence for its potential as a once-yearly option for PrEP.
The company is also exploring several potential options for PrEP, including a drug-eluting implant and a once-monthly oral formulation.
The company is “encouraged by the results of this proof of concept study exploring the potential of delivering meaningful doses of islatravir over a 12-week period,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, MSD Research Laboratories.
He continued, “At MSD, we recognise multiple options are needed to address the needs of individuals at risk of HIV-1, and we are committed to investigating those options. Through the application of our established expertise in drug delivery, we are seeking to capture the potential of islatravir for HIV-1 pre-exposure prophylaxis (PrEP).”