- Viriom's 20mg Daily Elsulfavirine (Elpida®)-based Regimen Demonstrated High Efficacy in High and Low HIV Titer Patients with Significantly Improved Safety Compared with 600mg Efavirenz-based Regimens -
SAN DIEGO, July 25, 2017 /PRNewswire/ -- Viriom, Inc (Viriom), a San Diego-based biotech company, today announced that on June 30, 2017 the Russian Ministry of Health (MoH) granted an approval to Viriom's non-nucleoside reverse transcriptase inhibitor (NNRTI) elsulfavirine (brand name Elpida®). Non-nucleoside reverse transcriptase inhibitors block HIV replication. The labeling requested was for the "treatment of HIV-1 infection in combination with other antiretroviral medicines." Viriom's first product on the market, elsulfavirine is a new-generation, potentially the best in class prodrug NNRTI approved for the treatment of the HIV-1 virus due to its potency, pharmacokinetic properties and favorable resistance profile.
The Russian MoH based its approval of elsulfavirine on the results of a 48-week multicenter comparative clinical study conducted in 12 clinical centers. The results presented to the MoH confirmed an efficacy non-inferior to efavirenz (currently used as a first-line treatment of HIV-1); elsulfavirine demonstrated equally superior efficacy in patients with a high or low HIV titer at baseline. Overall, it was 2-4 times safer and better tolerated than efavirenz including a lower frequency of adverse events related to the CNS, with no allergic reactions or skin rash observed. Elsulfavirine demonstrated a higher genetic barrier to the development of resistant drug mutations. Elsulfavirine is available as a 20mg capsule to be taken orally. Viriom is continuing the development of fixed dose combinations of elsulfavirine for the treatment of the HIV-1 infection and working towards market registration of elsulfavirine and fixed dose combinations globally. Viriom is also developing long-acting, injectable formulations of parent drug VM1500A for treatment and prevention of the HIV-1 infection based on the unique pharmacokinetic and pharmacodynamic properties of elsulfavirine demonstrated in clinical trials to date.
Viriom 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 antiviral treatments. Viriom's broad, proprietary, and partnered pipeline covers therapeutic, prophylactic, and curative medicines for HIV and viral hepatitis. Learn more at www.viriom.com.
Ronald Demuth, CFO, Viriom
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