SAN DIEGO, Feb. 2, 2021 /PRNewsCentre/ — Viriom Inc (Viriom) announces that its antiviral drug Elpida®(elsulfavirine) has been included in the preferred first-line antiretroviral therapy (ART) regimens by the Ministry of Health of the Russian Federation according to updated clinical guidelines for the treatment of HIV infection in adults and children. Regimens for adults include the combination of elsulfavirine + lamivudine (or emtricitabine) + tenofovir. Viriom has filed for the market authorization of the fixed dose combination of elsulfavirine + tenofovir and emtricitabine in Russia and the Eurasian Economic Union.
Elsulfavirine (Elpida®) is a pro-drug and converted into the active metabolite VM-1500A (deselsulfavirine), an unique and novel non-nucleoside reverse transcriptase inhibitor (NNRTI) with a proven superior safety and tolerability profile, long acting pharmacology and lack of sensitivity to viral mutations resistant to other NNRTi drugs.
Clinical studies of elsulfavirine (Elpida®) assessed the safety, tolerability and pharmacokinetics in subjects with impaired liver function and following co-administration with either rifampicin or sofosbuvir. Based on the results of these studies, elsulfavirine was recommended as part of the ART regimen for HIV patients with mild to moderate liver dysfunction, as well as for patients with co-infection (HIV infection and tuberculosis or hepatitis C) receiving rifampicin or sofosbuvir, respectively.
The interim analysis of the post-approval use of Elpida® in clinical practice, which included 1296 patients, also confirmed the efficacy and safety results obtained during the registrational clinical trials. Among the HIV-positive patients who had not previously received treatment and completed 48 weeks of elsulfavirine therapy, more than 90% had undetectable viral load, regardless of their baseline viral level. The drug was well tolerated, with no new safety concerns.
"The results of these recent studies have confirmed slow release with sustained therapeutic concentration levels, which would enable VM1500A to be used once every 4 to 8 weeks," said Dr. Iain Dukes, CEO of Viriom Inc. "Now we know that VM1500A is also safe for patients with hepatic impairment and co-infection, increasing its potential as an HIV-1 long-acting therapy for pre-exposure prophylaxis (PrEP)."
Viriom is conducting a broad development program to evaluate the potential of elsulfavirine/VM1500A for the treatment and prevention of HIV-1 infection. While a 20mg daily capsule formulation of elsulfavirine is already approved in Russia (Elpida®) and the Eurasian Economic Union, the robust efficacy and favorable safety as well as the unique PK properties of the drug enabled the development of several follow-on programs. A once a week oral formulation of elsulfavirine is currently being studied in the US under an active Investigational New Drug (IND) application. In addition, market authorization submissions are under review in Thailand, China, Colombia, Indonesia, and South Africa. Furthermore, Viriom is conducting a clinical study of a once a month or even less frequent intramuscular and subcutaneous long-acting injectable nanoformulations of VM-1500A-LAI for the treatment of HIV-1 infection in Russia. The ongoing randomized Phase 2a study aims to select a therapeutic dose and assess the safety and efficacy of VM-1500A-LAI multiple injections in HIV-positive, virally suppressed patients comparing to the marketed Elpida® once a day oral regimen.
Considering the reporting of successful results of safety and pharmacokinetics of the oral once a week tablet formulation of elsulfavirine in Phase I studies and the advantageous distribution of elsulfavirine in lymphoid and epithelial tissues, Viriom is exploring options for oral PrEP formulations, and lower frequency oral HIV treatment including dosing with once a week oral tablets of elsulfavirine.
About pro-drug elsulfavirine and parent drug deselsulfavirine
Deselsulfavirine (VM1500A) is Viriom’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTi), currently being evaluated in clinical trials for the treatment of HIV-1 infection in combination with other antiretrovirals, as well as for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a single investigational agent, across a variety of formulations. Elsulfavirine, the pro-drug of VM1500A, is currently being marketed for the treatment of HIV-1 infection in combination with other antiretrovirals as an oral 20mg once a day capsule formulation. Elsulfavirine is also being evaluated in clinical trials for the treatment of HIV infection as an oral, once a week tablet and for the treatment of COVID-19 infection.
Viriom (San Diego, CA) focuses on the treatment, prophylaxis, and eradication of infectious diseases globally. Viriom is developing and commercializing the most innovative and affordable solutions to radically expand global access to the best antiviral treatments. Viriom’s broad, proprietary, and partnered pipeline covers therapeutic, prophylactic, and curative medicines for HIV, viral hepatitis and respiratory infections. Learn more at www.viriom.com.
Iain Dukes, DPhil, email@example.com