Merck has succeeded in its Phase 3 trial for doravirine, an HIV-1 infection drug, by meeting efficacy and safety primary endpoints, the company said Tuesday.

Encouraged by the success, Merck will push ahead with submitting New Drug Applications to the U.S. FDA in the last quarter of 2017, it added.

Merck, also known as MSD outside the U.S. and Canada, presented results from the DRIVE-AHEAD study at the 9th International Conference on HIV Science in France. The study evaluated the safety and efficacy of doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI).

The investigational drug used to treat HIV-1 infections showed that a once-daily single tablet, a fixed-dose combination of doravirine and two other drugs (lamivudine, tenofovir disoproxil fumarate), proved non-inferiority to the compared drug combination (efavirenz, emtricitabine, and TDF).

The trial, conducted for 48 weeks on untreated HIV-1 adult patients, showed patients taking the doravirine combination reported fewer side-effects such as dizziness, sleep disorders, and inability to think clearly.

“Data from DRIVE-AHEAD at 48 weeks show that a fixed-dose combination tablet containing doravirine achieved viral suppression in HIV-1 infected treatment-naïve adults, comparable to a fixed-dose combination containing efavirenz,” said Dr. Kathleen Squires, a study investigator. “The results for doravirine are encouraging, as it may offer appropriate patients a new single-tablet treatment option.”

HIV affects around 1.1 million people in the United States with 1 in 7 unaware of having the disease. 39,513 people were diagnosed with HIV in 2015 alone in the U.S.

“For more than 30 years, Merck has been at the forefront of HIV research, making a difference for people living with HIV,” said Dr. George Hanna, associate vice president, clinical research, Merck Research Laboratories. “Based on our encouraging Phase 3 study findings, we plan to file regulatory applications in Q4 2017.”

Copyright © KBR Unauthorized reproduction, redistribution prohibited