A Triangle drugmaker is beginning trials for a potential treatment for Covid-19 while at the same time the company is close to locking down a federal contract to stockpile treatments for another deadly disease.
Durham-based Chimerix (Nasdaq: CMRX) has begun a Phase 2/3 study for one of its drug assets, dociparstat sodium (DSTAT), in Covid-19 patients suffering from acute lung injury.
The drug has been under development by the company for years, most recently being explored as a treatment for Acute Myeloid Leukemia patients in a Phase 2 study. But the company has realized that it may prove to be an advantageous treatment for some hospitalized coronavirus patients suffering from acute lung injury, says Chimerix CEO Mike Sherman.
Sherman says the company has been working “closely with critical care physicians treating Covid-19 patients” and with the U.S. Food and Drug Administration (FDA) – those partnerships led to the latest trials. The Phase 2/3 trial will seek to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in Covid-19 patients in severe condition.
“The FDA has actually been great with the pace of which they reviewed our materials and our proposal,” he says. “I was really pretty impressed, they’re obviously working hard and trying to work with companies to try to expedite the programs, so they were very supportive of us.”
However, Sherman says the company has not yet received any federal funding for the trial because they did not want to “wait for that process.” He says they are applying for funding while the trial continues.
The news that federal regulators have accepted the company’s plan to explore DSTAT is not the only potential pay-out the company may soon see.
The company has officially received approval from the FDA for submission of its new drug application (NDA) for brincidofovir (BCV) as a medical countermeasure for smallpox.
Smallpox was eradicated in the late 1970s, but Sherman says the country is mandated to have two potential treatments for the virus stockpiled at all times. If approved, Chimerix will receive a federal contract to stockpile its drug.
The company has been developing BCV as a potential medical countermeasure for smallpox with funding and collaboration from the Biomedical Advanced Research and Development Authority.
The company plans to begin the NDA process by the end of this month, with completion targeted for mid-year.
“That sets the stage for that stockpile procurement agreement and the funding associated with that,” he says. “Essentially, the revenue we get from putting that drug into the stockpile we plan to use to develop other innovative therapies.”
While the exact value of that contract is not clear at this time, Sherman says the last drug to be added to the stockpile brought about $500 million in awards over a five to seven-year contract. He says the length of the contract is designed to produce the drugs at different times so they do not expire at the same time.
“The value of being prepared for viral outbreaks has never been clearer,” he says. “The potential for engineered or naturally occurring resistance to the currently approved therapy has made the development of BCV imperative.”
Original Article Source: Triangle Business Journal