Viriom, Inc. announced the initiation of a Phase 2 clinical study to evaluate the efficacy of elsulfavirine in adults with moderate manifestations of COVID-19 (novel coronavirus).
San Diego, CA --(PR NEWS
WIRE) --April 8, 2020 -- Viriom, Inc.
today announced the initiation of a Phase 2 clinical study to evaluate the
efficacy of elsulfavirine in adults with moderate manifestations of COVID-19 (novel coronavirus). This randomized,
open-label, multicenter study will enroll approximately 240 patients at medical
centers primarily across Russia and EAEU countries, as well as other countries
globally with high numbers of diagnosed cases, beginning in May. The study will
assess two doses of elsulfavirine, administered as oral tablets. Elsulfavirine
is marketed in Russia and EAEU countries for the treatment of HIV infection.
The new clinical study expands the
ongoing research into elsulfavirine, which includes confirmation of elsulfavirine
antiviral activity against COVID-19 infection
by the State Key Laboratory of Diagnosis and Treatment of Infectious
Diseases, Zhejiang University in China.
“We would like to define
elsulfavirine efficacy as a potential treatment for COVID-19 which will
complement its safety and tolerability
in high doses of up to 1200mg and uniquely long 7.5 day half life. We would
like to further investigate elsulfavirine in a combination with favipiravir,
which is manufactured by Viriom-affiliated ChemRar Group, for the treatment of
severe COVID19 infection. We appreciate the concerted effort of China CDC,
Zhejiang University and other global research partners in accelerating the response to this public
health emergency, “ said Nikolay Savchuk, PhD, Chairman Viriom Inc
About
Elpida® (elsulfavirine):
Elsulfavirine
is an investigational new drug that is being studied in once daily and once
weekly oral long-acting formulations to treat HIV infection. Elsulfavirine was approved for treating HIV
infection in Russia and Kazakhstan and has been submitted for marketing
approvals in multiple countries in South
East and East Asia, and Latin America. U.S. Food and Drug Administration’s
(FDA) accepted Viriom’s investigational new drug (IND) filing for elsulfavirine
for the once weekly treatment of HIV infection. Elsulfavirine belongs to a
group of HIV drugs called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). Studies have shown that elsulfavirine appears effective for treating
HIV in people who have not previously taken HIV medicines. Elsulfavirine may be
effective against certain strains of HIV that can no longer be controlled by
FDA-approved NNRTIs or other viral infections. Viriom is also developing a
long-acting oral formulation of elsulfavirine and a long acting injectable
formulation of an investigational new drug VM1500A-LAI to prevent and treat
HIV.
About
Favipiravir
Favipiravir
an antiviral drug being developed by Toyama Chemical (Fujifilm group) of Japan
with activity against many RNA viruses. It was approved in 2014 for treating
viral strains unresponsive to current antivirals. On 15 March 2020 the drug was
approved in China with the name Favilavir for the treatment of influenza. The
drug was also approved for use in clinical trials for treating coronavirus
disease 2019 pneumonia. On 22 March 2020 Italy approved the drug for
experimental use against COVID-19 and has begun conducting trials in 3 regions
most affected by the disease. On March 26th the Russian Direct Investment Fund
(RDIF), Russia’s sovereign wealth fund, and
ChemRar Group announced creation of the joint venture for the manufacturing
of favipiravir and other innovative
antiviral medicines to treat COVID-19 infection.
About
Viriom-Sponsored Elsulfavirine Clinical Trial
The study will evaluate
the safety and efficacy of both a 5-day and a 10-day dosing regimens of elsulfavirine
administered as oral tablets in patients with moderate manifestations of
COVID-19. Approximately 240 participants will be randomized in a 2:1 ratio to
receive elsulfavirine 1200 mg on day
one, followed by elsulfavirine 200 mg or 400mg each day in combination with 500mg azithromycin each
day until day 5 or 10, in addition to
standard of care. The primary objective of this study is to evaluate the effect
of elsulfavirine, as measured by the proportion of participants in each group
discharged by day 14.
About
Viriom:
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, viral
hepatitis, flu coronaviruses and other pathogenic infectious diseases. Learn
more at www.viriom.com
