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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).

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


Elpida® (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





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.


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.




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

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