SAN DIEGO, Dec. 21, 2018 /PRNewswire/ — Viriom (San Diego, CA) announced today that it plans to report results from its Phase 1b clinical trial of once weekly dosing of oral elsulfavirine (Elpida®, VM1500), a potent long acting nonnucleoside reverse transcriptase inhibitor (NNRTI) in HIV-uninfected volunteers in March 2019. This trial is designed to evaluate the safety and pharmacokinetics of elsulfavirine dosed once weekly for up to 8 weeks in up to 36 HIV-uninfected volunteers at a single clinical site in Moscow, Russia.
Subject to confirmation of pharmacokinetics and safety, Viriom is planning a Phase 2A clinical trial of once weekly oral elsulfavirine in up to 24 HIV-infected patients in combination with other antiretroviral agents to determine the safety and efficacy of this low frequency treatment of HIV 1 infection. An earlier development program confirmed safety, tolerability, efficacy and pharmacokinetics of elsulfavirine in HIV1-infected patients dosed once daily with two other antiretroviral agents for up to 100 weeks.
"This dosing and safety trial is critical for establishing a unique oral once weekly therapeutic treatment and confirming its efficacy, safety and tolerability potential for long term pivotal studies," said Nikolay Savchuk, Ph.D., President and Executive Chairman, Viriom. "Our adaptive Phase 1b/2a study design approach is focused on providing streamlined results and data for the evaluation of elsulfavirine's potential to deliver a safe and efficacious once weekly option for the treatment of HIV infection. A seamless cooperation within the Viriom global development team has been proven by a successful development and approval of once daily oral elsulfavirine."
This Phase 1b trial (HIV-VM1500-09) is an open-label clinical study to evaluate the pharmacokinetics and safety of repeat dosing of elsulfavirine during an 8-week once weekly oral dosing in HIV-uninfected volunteers. After 14 days screening subjects are randomized to one of three treatment groups (40 mg, 80 mg, or 160 mg elsulfavirine) dosed once weekly in a 1:1:1 ratio. Subjects receive their randomized weekly dose of elsulfavirine orally for 8 weeks.
Subjects will undergo a series of safety assessments and pharmacokinetic samplings during the 8-week treatment period. Subjects will return for the end of treatment visit one week after completion of dosing. Subjects will also have two follow-up visits after completing the end of treatment visit.
The study participation for each subject will last for approximately 13 weeks, including 2 weeks of screening, 8 weeks of treatment and 3 weeks of follow-up.
Safety, tolerability, efficacy, pharmacokinetics and drug-drug interactions of Elpida® (20 mg elsulfavirine orally once daily) have been assessed in 7 complete Phase I to III clinical studies to date. Results of these trials demonstrate high antiviral and immunological efficacy of elsulfavirine non-inferior to efavirenz in 1st line antiretroviral therapy (ART) regardless of initial viral load, as well as good safety and tolerability profile superior to efavirenz in terms of adverse events from central nervous system, skin and allergic reactions. No resistance has been observed in conducted clinical studies up to date including one-week monotherapy and 96-week treatment in combination with Tenofovir disoproxil fumarate (TDF) and emtricitabine. Elsulfavirine has also shown the longest 7-9 days half-life of a parent drug among all the available NNRTIs.
Elsulfavirine received its first global approval in Russia in June 2017 and is recommended for treatment-naive HIV-1-infected patients in combination with other ART as a 1st line treatment choice.
A Phase IV Post-Approval Safety Study (PASS) of ELPIDA® in real practice in the first line therapy of HIV-1-infected patients with a background standard ART is currently in progress. To date 300 of planned 2000 patients have completed 24 weeks of treatment in this study. Additional clinical studies have been initiated to assess safety and efficacy of Elpida in HIV-infected persons with comorbidities and when co-administered with other drugs.
Elsulfavirine (Elpida®/VM-1500) is an orally bioavailable pro-drug of VM-1500A, which is a potent, highly selective novel NNRTI. Elsulfavirine showed potent antiviral activity with a high resistance barrier, a broad spectrum of activity against a variety of clinical forms of HIV-1, a favorable safety profile, as well as unique pharmacokinetic properties allowing for the development of long-acting dosage forms and fixed dose combinations.
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 and viral hepatitis. Learn more at www.viriom.com.
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Posted: December 2018
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