Viriom Initiates Phase 2 Clinical Study of Elsulfavirine for Treatment of COVID-19
- Category: Small Molecules
- Published on Wednesday, 08 April 2020 18:43
- Hits: 1515
SAN DIEGO, CA, USA I April 8, 2020 I 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 COVID-19 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.
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.
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