SAN DIEGO, Dec. 20, 2018 /PRNewswire/ -- Viriom, Inc. (San Diego, CA) announced today that it has initiated the first Phase 1 clinical trial of the long acting nanoformulation of VM1500A in HIV-uninfected volunteers. This trial is designed to evaluate the safety and pharmacokinetics of VM1500A once monthly dosing in up to 36 HIV-uninfected volunteers in a single site clinical trial in Moscow, Russia.
Animal studies of VM1500A long acting injectable (VM-1500A-LAI) have shown an excellent pharmacokinetic profile suggesting feasibility of once monthly or once quarterly dosing to achieve effective antiviral target exposure. Viriom is evaluating intramuscular and subcutaneous injectable formulations of VM-1500A-LAI.
An early development program for VM-1500A-LAI has been co-sponsored by a grant from the Skolkovo Foundation to the Viriom affiliate Viriom Ltd. Viriom Ltd commercializes Elpida® (elsulfavirine), a highly potent nonnucleoside reverse transcriptase inhibitor (NNRTI) pro-drug that was optimized for oral bioavailability and broad-spectrum activity against HIV-1. Elpida was launched in Russia in 2017 and is indicated for the treatment of HIV infection in combination with other anti-retroviral agents. Elpida is in the process of obtaining marketing authorization in a number of additional markets. Viriom is developing a fixed dose combination of elsulfavirine, emtricitabine and a tenofovir for a first market launch in 2019. Viriom Ltd is clinically developing therapies for HIV and HBV therapy in Russia in coordination with the Viriom global development team.
"This trial is an important step in confirming the safety and tolerability of the nanosuspension formulation of VM1500A for long acting once monthly and potentially less frequent injections. After this we will conduct further studies in HIV-infected individuals," said Nikolay Savchuk, Ph.D., President and Executive Chairman, Viriom, Inc. "The expeditious movement of VM1500A into early clinical development Phase I/II trials is an impressive result of the Viriom global team commitment to delivering best in class HIV treatment and prevention."
This Phase 1 trial (HIV-VM1500ALAI-01) is an open-label, single-center study to evaluate safety, tolerability and pharmacokinetics of VM-1500A-LAI in single and multiple ascending doses in HIV-uninfected volunteers. Thirty-six healthy volunteers will be enrolled in one of 6 dosing cohorts. After a 2-week run-in period of daily oral administration of 20 mg elsulfavirine, the volunteers will receive a single intramuscular injection of VM-1500A-LAI. After a 4-week follow-up period including PK assessments for each subject, a data review will be conducted by the Safety Review Committee (SRC) to recommend whether to proceed to the next dose level. According to results from the single ascending dose part of the study, two dose levels will be selected for consecutive multiple administration cohorts, receiving doses once monthly followed by SRC review.
Pre-clinical studies have evaluated different doses and schedules of VM-1500A-LAI in animals. Multiple monthly dosing in dogs resulted in persistent plasma levels of VM1500A above effective target levels with dose-related increases in Ctrough levels (Yakubova E et al. 2018, THPEA013, 22nd International AIDS conference, Amsterdam). Pharmacokinetic modeling based on these results indicates that once quarterly administration of VM1500A could be sufficient to achieve consistent efficacious plasma exposures of VM1500A.
"Currently, there is a clear need for new long acting and low frequency treatments," said Rob Murphy, M.D., Chief Medical Officer, Viriom. "The VM1500A program has provided unique and encouraging results in addition to the pre-clinical and clinical studies that have been performed since 2014."
VM1500A is a novel, potent NNRTI with broad-spectrum activity across HIV-1 variants. VM1500A has a long plasma half-life in humans (~7.5 days) and can be delivered orally with a pro-drug (elsulfavirine) that optimizes oral bioavailability of VM1500A, or by injection of the nanoformulation (VM-1500A-LAI).
HIV Long Acting Treatment
The current standard of care of HIV treatment is chronic treatment with daily administration of a combination of antiretroviral drugs. The development of long acting treatment options aims to achieve durable efficacy with infrequent dosing requirements (once weekly, monthly, quarterly or less). The availability of long acting treatment options will simplify the life-long management of HIV infection and thus has the potential to facilitate adherence, improve the quality of life and reduce the risk of treatment failure.
Viriom, Inc. (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.
Ronald Demuth, CFO, Viriom
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