Merck signs two deals for novel HIV drug candidates and initiates Phase II clinical trial of MK-1439 for HIV

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the company has signed two licensing agreements for investigational HIV drug candidates. Additionally, the company announced plans to initiate a Phase II study for a proprietary investigational next generation non-nucleoside reverse transcriptase inhibitor, MK-1439.

“Despite the tremendous advances made over the past 20 years, there remains considerable unmet need in the treatment of HIV infection,” said Robin D. Isaacs, M.D., vice president, infectious disease clinical research, Merck Research Laboratories. “Merck remains committed to improving on the standard of care for HIV therapy.”

Merck signed a deal with Chimerix Inc. based in Research Triangle Park, NC, for CMX157, an investigational oral nucleoside reverse transcriptase inhibitor currently in Phase I clinical development. Under the agreement, Merck will receive an exclusive worldwide license and will be responsible for development and commercialization of CMX157.

Separately, the company signed an agreement with Yamasa Corporation based in Choshi, Japan, to develop EFdA (4’-ethynyl-2-fluoro-2’-deoxyadenosine), a novel nucleoside reverse transcriptase inhibitor candidate that is in preclinical studies and has shown antiviral activity toward highly resistant HIV strains. As part of the agreement, Merck will pay an up-front fee and future milestone payments in return for exclusive worldwide license rights. This candidate was discovered in collaboration with a group led by the world renowned HIV research scientist Dr. Hiroaki Mitsuya of Kumamoto University’s Center for AIDS Research in Japan.

In addition, Merck announced plans to advance into Phase IIb clinical trial an internally developed candidate, MK-1439, a next-generation non-nucleoside reverse transcriptase inhibitor. Merck is initiating a dose-ranging clinical trial to evaluate the safety and tolerability and efficacy of MK-1439 in HIV positive, treatment-naive patients compared to efavirenz, both in combination with Truvada. The trial is expected to commence in September. More information is available at ClinicalTrials.gov using Identifier: NCT01632345.

Merck’s history in HIV research and access

Merck has been engaged in the fight against HIV/AIDS for more than two decades. In 1988, Merck researchers were the first to demonstrate that inhibiting the protease enzyme would prevent replication of HIV; the following year, Merck scientists published the first crystal structure for HIV protease. Years later, Merck scientists were the first to demonstrate inhibition of HIV integrase in vitro and in vivo. Currently Merck scientists are actively pursuing HIV research against at least five distinct targets and have several HIV compounds in development. Since our first HIV medicines became available, Merck has worked to expand access to these medicines, including through partnerships with others.