Westport medical technology company BioSig Technologies Inc. and its majority-owned subsidiary ViralClear Pharmaceuticals Inc. have received FDA approval to proceed with a proposed COVID-19 treatment.
ViralClear can now go forward with its phase II study of merimepodib oral solution in adults who are hospitalized with the coronavirus and either require supplemental oxygen or are on noninvasive ventilation or high-flow oxygen devices.
The study will be a randomized, double blind, placebo-controlled trial to evaluate the efficacy and safety of merimepodib as an orally administered treatment. The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen.
ViralClear expects to begin enrollment of the trial as soon as practicable.
“We intend to conduct Phase II evaluations of our drug both in the hospital and outpatient settings as part of our clinical development plan,” said Jerome B. Zeldis, executive chair, co-founder and acting chief medical officer of ViralClear.