Candidate: Merimepodib (MMPD; also called Vicromax™)

Type: Oral antiviral candidate targeting RNA-dependent polymerases.

Status: ViralClear said July 13 that it had launched enrollment of adult patients for a Phase II trial (NCT04410354) designed to evaluate merimepodib in adult patients with advanced COVID-19. The patients, who are hospitalized and require oxygen, are being enrolled at four trial sites that include three from the Mayo Clinic—including Rochester, MN, Jacksonville, FL, Phoenix, AZ—as well as St. David’s South Austin Medical Center in Austin, TX.

An estimated 40 patients are set to be enrolled in the trial, whose primary endpoints include number of subjects not hospitalized, or hospitalized and free of respiratory failure, as well as numbe of adverse events. The first patient was dosed in June, ViralClear said at the time.

The trial’s lead investigator is Andrew D. Badley, MD, Professor and Chair of Department of Molecular Medicine and the Enterprise Chair of COVID-19 Task Force.

Five days earlier, ViralClear said July 8 it was partnering with CDMO Albany Molecular Research Inc. (AMRI) in studying the potential of merimepodib to fight SARS-CoV-2, either alone or in combination with other antiviral agents or immune modulators. AMRI is ViralClear’s second U.S.-based active pharmaceutical ingredient (API) supplier. In a statement, ViralClear Chief Operating Officer Steve King cited the company’s need for rapid transfer, scale-up, and validation of merimepodib API manufacture—and ViralClear’s commitment to using U.S.-based CDMOs for the development and commercialization of merimepodib.

In April, BioSig said Jerome Zeldis, MD, PhD, Executive Chair and co-founder of BioSig subsidiary ViralClear, served as corresponding author for a study highlighting in vitro data generated by the combination of merimepodib and Gilead Sciences’ remdesivir. The study, published May 13 in F1000 Research, reported that at 16 hours, a significant reduction in viral production was seen for both 2.5 and 5 µM concentrations of merimepodib, but only at the higher concentration of remdesivir.

At 24 hours, both concentrations of both drugs significantly reduced viral production—but 2.5 µM remdesivir reduced viral titer by 1.5 logs, compared to a decrease of 3.9 logs for 5 µM remdesivir, whereas 2.5 and 2.7 log reductions were seen for the 2.5 and 5 µM concentrations of merimepodib.

The data was generated under ViralClear’s contract with Galveston National Laboratory at The University of Texas Medical Branch. The work began with Trek Therapeutics, and continued with ViralClear after it acquired merimepodib.

In a preprint published April 9, ViralClear researchers reported the first preclinical data on merimepodib in SARS-CoV-2, generated with Galveston National Laboratory at The University of Texas Medical Branch. The data showed that merimepodib decreased viral production by over 98%, suppressing SARS-CoV-2 replication in vitro. After overnight pretreatment of Vero cells with 10 μM of MMPD, viral titers were reduced by 4 logs of magnitude, while pretreatment for 4 hours resulted in a 3-log drop.

“MMPD may therefore be a viable treatment option for COVID-19 that can be quickly tested and deployed,” the researchers concluded.

Merimepodib has shown activity against a broad spectrum of RNA viruses and has generated satisfactory safety data from more than 300 patients treated for hepatitis C, BioSig said.

Zeldis joined ViralClear on March 31 after serving as CEO of Celgene Global Health and Chief Medical Officer of Celgene, acquired last year by Bristol-Myers Squibb for $74 billion.

 

Zeldis joined ViralClear on March 31 after serving as CEO of Celgene Global Health and Chief Medical Officer of Celgene, acquired last year by Bristol-Myers Squibb for $74 billion.


COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA