Merck Initiates EXPrESSIVE Phase III Trial for Once-Monthly HIV PrEP Drug MK-8527

Merck Initiates EXPrESSIVE Phase III Trial for Once-Monthly HIV PrEP Drug MK-8527

Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) announced the initiation of the EXPrESSIVE Phase III clinical trial program to evaluate the safety and efficacy of its investigational once-monthly oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) MK-8527 for HIV pre-exposure prophylaxis (PrEP). This marks a significant advancement in the development of novel HIV prevention strategies.

Drug Mechanism and Development
MK-8527 is an investigational once-monthly oral HIV-1 prevention drug that works through multiple mechanisms, including reverse transcriptase translocation inhibition and delayed chain termination. This innovative approach offers a new potential option for individuals at high risk of HIV exposure.

Global Trial Expansion
The EXPrESSIVE-11 trial (MK-8527-011, NCT 07044297) will enroll individuals at high risk of HIV-1 exposure across 16 countries, with patient recruitment set to begin in August 2025. Additionally, the EXPrESSIVE-10 trial (MK-8527-010), conducted in collaboration with the Bill & Melinda Gates Foundation, will launch in the coming months. This trial will specifically assess the safety and efficacy of MK-8527 among women and adolescent girls in sub-Saharan Africa, highlighting the global commitment to addressing HIV prevention in vulnerable populations.-Fineline Info & Tech