Our goal: to make the world a safer place by developing a therapeutic platform to address existing and emerging pathogenic threats, including COVID-19, so that people can engage in everyday life normally and safely.
Our subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), is comprised of an accomplished team of pharmaceutical industry veterans who are working to provide safe and efficacious treatments for pathogenic threats. ViralClear is currently developing merimepodib, a novel, orally administered, broad-spectrum, host-directed, antiviral agent for the treatment of COVID-19.
An Urgent Global Challenge:
At the time of writing (October 19, 2020), SARS-CoV-2, the novel coronavirus that causes COVID-19, has resulted in over 40 million confirmed global cases and 1.1 million global deaths.* As the United States and other countries continue to struggle with public health and economic burdens due to COVID-19, the need for effective treatments is urgent.
The last time the world responded to a global emerging disease epidemic of the scale of COVID-19 was the 1918-1919 H1N1 influenza pandemic, which killed at least 50 million people globally. Even with modern technology and healthcare, some experts predict that COVID-19 is on track to become the third leading cause of death in the US by the end of the year*.
*Source: University of Washington's Institute for Health Metrics and Evaluation (IHME) COVID-19 Projections and the Centers for Disease Control and Prevention Leading Causes of Death
ViralClear is developing merimepodib, a novel, orally administered, host-directed, antiviral agent to treat COVID-19.
Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis, undergoing extensive nonclinical and clinical testing (including 12 clinical trials with more than 400 subjects). Due to its demonstrated broad-spectrum, antiviral activity, merimepodib is currently being developed as a treatment for COVID‑19 when used alone or in combination with other antiviral agents or immunomodulators.
In a cell culture model, merimepodib was shown to significantly reduce SARS-CoV-2 viral titers, with the combination of merimepodib and remdesivir reducing the titers to undetectable levels. ViralClear is currently conducting a Phase 2 trial of an oral solution of merimepodib in combination with intravenously infused remdesivir for the treatment of patients with advanced COVID-19.
Merimepodib is a small molecule which can be easily scaled to produce the quantities of product required for global treatment.
On May 13, 2020, ViralClear’s Jerome B. Zeldis, co-authored and contributed to an F1000 Research article on merimepodib. The in vitro study focused on testing merimepodib in combination with remdesivir, an antiviral that was recently authorized for emergency use in the US.
The researchers found that in a cell culture model, the combination of merimepodib and remdesivir reduced the production of SARS-CoV-2 virus more effectively than either drug alone. At concentrations comparable to blood levels that have been achieved clinically, the SARS-CoV-2 was undetectable. This research supports the hypothesis that the combination of merimepodib and remdesivir may be an effective treatment for COVID-19.
On June 17, 2020, ViralClear announced the commencement of patient enrollment in its Phase 2 trial for merimepodib in combination with remdesivir. The study is a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of orally administered merimepodib in combination with intravenously infused remdesivir in hospitalized patients who have confirmed infection with SARS-CoV-2 and who either require supplemental oxygen or are on non-invasive ventilation or a high flow oxygen device.
On July 20, ViralClear announced the formation of its scientific advisory board (SAB). The SAB will review all aspects of drug discovery and development and will advise the Company on its mission to control emerging infections and viral diseases of special interest, including COVID-19. The board is comprised of Robin Robinson, Ph.D., the former Head of Biomedical Advanced Research and Development Authority (BARDA), J. Paul Waymack, M.D., ScD, formerly of the Food and Drug Administration (FDA), Dr. Michael J. Sofia, the principal inventor of sofosbuvir (currently marketed as the backbone of hepatitis C curative therapies), and Angus Dalgleish, M.D., the Foundation Chair of Oncology and Honorary Consultant in Medical Oncology at St. George's University and Hospital in London and Principal of the Institute of Cancer Vaccines and Immunotherapy.
On September 22, 2020, ViralClear announced a size increase of the ongoing randomized, double-blind, placebo-controlled Phase 2 trial of merimepodib in combination with remdesivir from 40 to 80 subjects. The decision to increase the trial's subject number was based on advice from industry experts and discussions with government agencies and non-governmental organizations. Once additional subjects are enrolled, and further clinical data is obtained, the team will discuss the appropriate size for a Phase 3 trial with the FDA. The Company also announced two new Principal Investigators for the ongoing Phase 2 trial, expanding the total number of hospital locations to 10.
On September 30, 2020, ViralClear announced a partnership with Sorrento Therapeutics, Inc. (Nasdaq: SRNE). The companies are exploring the synergistic potential of small molecules and antibodies combination therapies against COVID-19. ViralClear and Sorrento's agreement will allow for the testing of merimepodib with neutralizing antibodies in the Golden Syrian hamster model of COVID-19. Sorrento will initially make available STI-1499 neutralizing antibody candidate for testing.
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This is the most significant healthcare crisis in a generation. With passion and urgency, ViralClear Pharmaceuticals, Inc. is committed to doing everything it can to help.
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