FDA Clears IND for Antiviral Merimepodib, Phase II Trial is Planned

The US Food and Drug Administration (FDA) today informed pharmaceutical manufactuer ViralClear Pharmaceuticals, Inc, that it had completed its review of the company's Investigational New Drug (IND) application.

The company announced in a press release that ViralClear may now proceed with its proposed phase II study of the antiviral agent merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.

This study will be a randomized, double blind, placebo-controlled trial to evaluate the efficacy and safety of merimepodib as an orally administered treatment. The phase II trial is expected to be conducted at multiple centers in the United States, including 3 Mayo Clinic sites under the leadership of Andrew D. Badley, MD, chair, Mayo Clinic COVID-19 Research Task Force.

“I’m very pleased to be involved in this planned Phase II study of merimepodib for the treatment of patients with COVID-19 disease,” said Dr Badley in the ViralClear press release. “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.”

“FDA clearance for our proposed phase II trial to proceed is an important step for the development of merimepodib,” commented Jerome B. Zeldis, MD, PhD, executive chair, co-founder and acting chief medical officer of ViralClear Pharmaceuticals, Inc, in the same news release. “We intend to conduct Phase II evaluations of our drug both in the hospital and outpatient settings as part of our clinical development plan.”

“Of the therapies that are currently being evaluated as treatments and can be available in the short term, we believe that a broad-spectrum antiviral that is orally administered and widely available could be very helpful in addressing the COVID-19 pandemic," said Nick Spring, chief executive officer of ViralClear Pharmaceuticals, Inc, in the release. "We further believe it can play a pivotal role in helping manage this type of public health crisis.”

Merimepodib is a broad-spectrum antiviral candidate that has shown strong activity against COVID-19 in cell cultures in laboratory testing. Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis with more than 10 clinical trials conducted andan extensive preclinical safety package completed.

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