SAN DIEGO, Feb. 17, 2017 /PRNewswire/ -- Viriom, Inc. announced the top-line results of its Phase IIb comparator study of Elpida® versus Efavirenz (EFV) in combination with Tenofovir/Emtracitabine (TDF/FTC) at the Conference on Retroviruses and Opportunistic Infections (CROI 2017).
The study was presented by Professor Robert Murphy, Northwestern University, Chicago, as a late-breaker poster. In this Phase IIb, randomized, placebo-controlled, double-blind, multicenter study, 120 antiretroviral therapy (ART)-naïve HIV-1-infected patients were treated with once-daily oral dosing with either 20 mg Elpida or 600 mg Efavirenz in combination with TDF/FTC for 48 weeks. Sixty patients were assigned to each of the Elpida and EFV treatment groups.
Both 20 mg Elpida and 600 mg QD EFV treatment groups showed an acceptable decrease in HIV-1 viral loads compared to baseline. More Elpida patients (91.7%) completed treatment than EFV patients (78.3%), and Elpida patients had fewer adverse events (AEs), including central nervous system and skin adverse events.
"We are excited about these clinical results," commented Dr. Vadim Bichko, Viriom's Chief Scientific Officer. "This 48-week study demonstrated equivalent virologic and immunologic efficacy of ART regimens including 20 mg Elpida or 600 mg EFV in ART-naive HIV-1 infected patients. Elpida was significantly better tolerated than EFV-based therapy, offering a safer alternative to EFV-based ART."
Viriom is an emerging leader in the development of innovative antiviral drugs and drug combinations, as well as treatment and diagnosis methods. Viriom's most advanced drug is Elpida/elsulfavirine, a once-daily oral prodrug of VM-1500A, a novel HIV non-nucleoside reverse transcriptase inhibitor (NNRTI). Viriom expects to obtain first market registration for Elpida in 2017. Development is underway for once-weekly oral and longer-acting parenteral formulations of Elpida/elsulfavirine, as well as drug combination formulations. Learn more http://viriom.com/
SOURCE Viriom, Inc.