FDA clears way for study of merimepodib against COVID-19

[Image courtesy of CDC]

BioSig Technologies (Westport, Conn.) said today that its majority-owned ViralClear Pharmaceuticals subsidiary has secured FDA clearance for an Investigational New Drug application to use merimepodib to treat advanced COVID-19 cases.

FDA told ViralClear that it may proceed with a phase II trial — a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of merimepodib as an orally administered treatment.

The clinical trial will take place at multiple centers in the United States, including three Mayo Clinic sites under the leadership of Dr. Andrew D. Badley.

“We are grateful to the FDA for their prompt response in helping accelerate opportunities to find treatments for the novel coronavirus. We plan to begin enrollment of this trial as soon as practicable given the importance of finding solutions to this pandemic,” Badley, who is the chair of Mayo Clinic’s COVID-19 research task force, said in a BioSig news release.

Merimepodib is a broad-spectrum anti-viral candidate that has demonstrated strong activity against COVID-19 in cell cultures in laboratory testing, according to BioSig. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceutical.

Early this month, FDA granted an EUA for use of Gilead Sciences’ remdesivir experimental drug to treat COVID-19.