Merck Presents Early Data on Extended Delivery Subdermal Anti-HIV-1 Agent

Merck & Company (NYSE: MRK), known as MSD outside the United States and Canada, announced today results from a Phase 1 study evaluating the pharmacokinetics and safety of a prototype subdermal drug-eluting implant for extended administration of islatravir, the company’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI), in healthy volunteers. The early findings of this prototype were presented as a late-breaking oral presentation (Abstract TUAC0401LB) at the 10^th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City and featured in the official IAS 2019 press program.

“We are 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, Merck Research Laboratories. “At Merck, we recognize 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).”

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. The company is also exploring several potential options for PrEP, including a drug-eluting implant, as noted above, and a once-monthly oral formulation. The investigational once-daily, 2-drug regimen for the treatment of HIV-1 treatment will be presented as a late-breaking oral presentation tomorrow (July 24) and is in the official press program at the IAS 2019. For the once-monthly oral formulation for PrEP, Merck plans to initiate a Phase 2, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of investigational oral islatravir once-monthly in participants at low- risk for HIV-1 infection (ClinicalTrials.gov: NCT04003103). The trial is due to commence recruitment in September 2019.

https://www.biospace.com/article/releases/merck-presents-early-evidence-on-extended-delivery-of-investigational-anti-hiv-1-agent-islatravir-mk-8591-via-subdermal-implant/