Biosig cleared to test merimepodib plus remdesivir in COVID-19

US biotech BioSig Technologies’ subsidiary ViralClear has been cleared by the FDA to start a phase 2 trial of its antiviral drug merimepodib in patients who are severely ill with COVID-19.

The orally-active drug will be tested multiple sites in the US - including three Mayo Clinic locations - in adults with COVID-19 who have been hospitalised and need oxygen support or a non-invasive ventilator or oxygen device.

BioSig says the new study will involve around 40 patients who will be randomised to treatment with either a combination of merimepodib and Gilead Sciences’ remdesivir, or remdesivir and placebo, with first results expected next month.

In preclinical testing, merimepodib – also known as Vicromax – has been found to suppress replication of SARS-CoV-2, the virus that causes COVID-19. It has also been shown to work in tandem with remdesivir, cutting viral replication to "undetectable levels" at low concentrations.

Testing the drug with remdesivir immediately elevates the prospects of merimepodib to the top tier of coronavirus drug candidates, as Gilead’s drug is at the forefront of COVID-19 treatment at the moment.

Remdesivir has already been approved as treatment under emergency measures in the US and Japan and – according to some sources – it could be given a green light in Europe in the coming days.

Merimepodib – originally developed by Vertex Pharma – is an inhibitor of the enzyme inosine monophosphate dehydrogenase (IMDPH), which is required for the synthesis of viral RNA.

It reached the phase 2b testing stage in hepatitis C before being dropped from development because it showed only modest improvements over established drugs, but is still being evaluated for other viral diseases, including Zika, foot and mouth virus and now SARS-CoV-2.

The combination trial will be led by the Mayo Clinic’s Andrew Badley, a specialist in viral diseases and molecular medicine, who said: "We plan to begin enrolment of this trial as soon as practicable given the importance of finding solutions to this pandemic."

BioSig has also said it plans to carry out additional trial in the outpatient setting with merimepodib monotherapy.

The company – which raised $10 million in a fundraising round earlier this year and focuses primarily on cardiovascular devices – is also considering a spin-out of ViralClear this summer, according to a Bloomberg Law report.