FDA clears phase 2 COVID-19 trial of ViralClear’s merimepodib

The US Food and Drug Administration (FDA) has cleared a pivotal phase 2 trial of ViralClear’s investigational antiviral merimepodib in patients hospitalised with COVID-19.

ViralClear may now proceed with its planned phase 2 study of merimepodib in adults with COVID-19 who have been hospitalised with the disease, and either require supplemental oxygen or are on non-invasive ventilation/high flow oxygen devices.

The phase 2 trial will be conducted at a number of centres across the US, including at three Mayo Clinic sites under the leadership of Andrew Badley, the enterprise chair of the COVID-19 Task Force.

“We thank the Mayo Clinic for collaborating with us to conduct the trials under the leadership of Professor Badley,” said Nick Spring, chief executive officer of ViralClear Pharmaceuticals.

“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. We further believe it can play a pivotal role in helping manage this type of public health crisis,” he added.

Merimepodib has already been in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals, with 12 clinical trials having been previously conducted.

Another investigational antiviral, Gilead’s remdesivir, has had huge success as a result of the pandemic after early preclinical tests demonstrated activity against SARS-CoV-2, the virus that causes COVID-19.

Like merimepodib, remdesivir had already been investigated in a broad spectrum of viral diseases, including Ebola Zaire disease, severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS).

As global cases of COVID-19 near five million, the urgency for a broad range of treatments for the disease is becoming ever more crucial, especially as countries begin to ease strict lockdown restrictions.

Although a host of candidates are currently undergoing clinical testing, the number of those treatments which have received regulatory approval is still slim. Aside from an emergency use authorisation for remdesivir and hydroxychloroquine/chloroquine in the US and a similar approval for remdesivir in Japan, there are no approved therapeutics options for the treatment of COVID-19.