The Register Citizen (Torrington, CT)
Westport firm begins trials for COVID drug
WESTPORT — A subsidiary of a local medical device company is entering a second phase of clinical trials for a new oral COVID-19 treatment.
Studies of the drug, called merimepodib and developed by ViralClear Pharmaceuticals, a subsidiary of Westport’s BioSig Technologies, will soon start human clinical trials in as many as eight hospitals nationwide, according to the company’s executives.
During a teleconference last week with leaders from BioSig and ViralClear, Dr. Jerome Zeldis explained there are two separate trials set to begin, in which a total of 80 patients with COVID-19 will be studied.
“The first is the standard of care for patients who are hospitalized who require oxygen but are not yet intubated,” said Zeldis, executive chairman of ViralClear. “The standard of care right now is supportive care with supplemental oxygen and remdesivir (an antiviral medication recently authorized for use in the U.S). These patients will be randomized to use a placebo or our drug, merimepodib, and we will follow them.”
The second study will be conducted at facilities where remdesivir is not yet available. The first study will track the effectiveness of merimepodib in combination with remdesivir, while the second will provide insight on merimepodib’s effectiveness independently. According to Zeldis, early research has shown positive outcomes in instances when remdesivir and ViralClear’s drug are combined to fight the coronavirus. “The beauty of both these trials is that one trial will tell us what our drug can do by itself,” Zeldis said. “And we also think that the combination of remdesivir with our drug we should get as good, if not better, clinical response.”
The drug, initially called Vicromax, was acquired in March by BioSig through a separate subsidiary, NeuroClear Technologies. By April, ViralClear had formed and an application for a second round of studies was submitted to the U.S. Food and Drug Administration.
The FDA approved the drug for Phase II clinical trials on May 18, putting it in an elite group of treatments moving toward market as part of the federal Coronavirus Treatment Acceleration Program.
“There’s only a handful of drugs right now in Phase II or Phase III of trials in the USA and we’re one of them,” said Nick Spring, ViralClear chief executive officer.
Three months after the subsidiary was formed, BioSig and ViralClear secured $10.8 million in funding for the development of merimepodib and clinical studies, for which the companies are partnering with the MayoClinic. Results are expected to be available roughly three months after the trial starts.
Merimepodib performed well in clinical trials, especially when combined with remdesivir, reducing viral replication by as much as 98 percent. But, unlike remdesivir, which is administered intravenously, merimepodib is taken orally, which allows for both inpatient and out-patient use. Spring said that aspect of the drug gives BioSig and ViralClear a competitive advantage.
“Ultimately, the biggest market both for prevention and cure is going to be the out-patient market, not the in-patient market,” Spring said.