Barcelona, Spain, October 24th, 2015 - Viriom presented the results of a randomized, placebo-controlled, double-blind, dose-finding clinical trial of Elsulfavirine (VM-1500) in patients with HIV infection who are antiretroviral therapy-naïve at the EACS-2015 conference. Elsulfavirine is the pro-drug of the active compound VM-1500, a potent, highly selective NNRTI.
The purpose of these clinical trials was to evaluate the impact of different dosage regimens of Elsulfavirine (VM-1500) in combination with drugs used for standard antiretroviral therapy (ART) versus a combination containing efavirenz (EFV) and standard ART (2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTs)) on the efficiency of treatment in view of a reduction in viral load to an undetectable level (< 50 copies/ml) at 24 weeks in previously untreated HIV-1 infected patients. At this study stage (II), an interim analysis of the efficiency and safety of therapy was performed after a 12-week therapy.
In treatment-naïve patients, Elsulfavirine 20 and 40 mg QD (with TDF/FTC) at week 12 demonstrated potent antiviral activity, comparable to EFV, and favourable safety/tolerability profile. Fewer drug-related AEs were observed with Elsulfavirine compared to EFV. The safety of 12-week ART regimen incorporating Elsulfavirine (VM-1500) was higher than that of the regimen containing EFV. Elsulfavirine (VM-1500) 20 mg daily was chosen to be further investigated.
"Modern antiretroviral therapy is very effective, and, with the access to timely specialized care, the duration and quality of life of many HIV infected patients are almost comparable to healthy people," says Olga Aleshin, CEO of Viriom. "According to the results of the clinical trials, our Elsulfavirine drug improves the efficacy and safety of treatment in patients who have not received prior therapy. Elsulfavirine is being developed according to the international standards, in close international cooperation and in partnership with scientists from the Swiss company Hoffmann-La Roche. The development of domestic innovative antiretrovirals, their manufacturing and introduction into clinical practice is crucial in providing Russian patients with a new generation of highly effective drugs, becoming independent from drug imports and realizing the export potential of domestic products."