Coronavirus Drug: FDA Completes Review For Treatment Of COVID-19 Cases

ViralClear Pharmaceuticals Inc. said Monday it’s ready to enter phase 2 trials of its treatment for coronavirus. The company, a subsidiary of BioSig Technologies Inc. (BSGM), said the Food and Drug Administration has finished reviewing its new investigational drug application for merimepodib.

“We plan to begin enrollment of this trial as soon as practicable given the importance of finding solutions to this pandemic,” Dr. Andrew Badley, enterprise chair of the COVID-19 Task Force, said in a press release.

Chief medical officer Jerome Zeldis said the phase 2 trial would be set up as a randomized, double-blind, placebo-controlled clinical trial involving patients hospitalized with COVID-19 or who require supplemental oxygen outside the hospital.

The trial,which will involve 40 patients, is expected to take place across the nation, including at three Mayo Clinic sites.

Merimepodib originally was under development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Inc., and already has undergone seven phase 1 trials and five phase 2 trials involving more than 400 subjects, BioSig CEO Ken Londoner said in an email to IBTimes. It’s a broad-spectrum antiviral candidate that has shown strong activity against COVID-19 in laboratory cell cultures, ViralClear said.

It is similar to Gilead’s (GILD) remdesivir, which has shown what Dr. Anthony Fauci, head of the National Institute of Allergies and Infectious Disease, called “modest” results against COVID-19.

An analysis of data from the Galveston National Laboratory at the University of Texas Medical branch based on preclinical data on meripodib currently is undergoing peer review. The article says the drug reduces viral application to undetectable levels.

The news came as Moderna announced positive results for its coronavirus vaccine, mRNA-1273, in phase 1 testing.

By late morning Monday, nearly 90,000 Americans had died from COVID-19. Worldwide, the death toll was approaching 316,000.

Public health officials have warned of a possible surge in cases as restrictions are lifted, and states try to get their economies going again. As of Sunday, just 18 states still had stay-at-home orders in effect, but nearly all states were allowing some level of economic activity by nonessential businesses. Orders in Oregon, New Jersey, Kentucky and California had no expiration dates.