A day after receiving emergency use authorization for its Covid-19 antibody, InflaRx said it had enough supplies to treat several thousand patients. However, the drug will likely have a five-figure price tag.
InflaRx is aiming to make vilobelimab available as soon as possible, CEO Niels Riedemann said in a conversation with analysts on Wednesday. The drug, to be marketed under the name Gohibic, has been approved for use in critically ill adults within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.
That’s a much smaller patient population than Gilead’s antiviral Veklury, which launched for developed governments at $2,340 per course and is now approved for both inpatients and outpatients, Riedemann said. After discussions with payers, the chief executive said Gohibic’s list price will likely be a five-digit number, “and there won’t be a 1 as the first number,” he added.
The drug was approved about a year after the failure of a topline evaluation based on a site-stratified analysis of 28-day all-cause deaths. While the original protocol did not provide for site stratification, Riedemann said the company changed the protocol based on recommendations from regulators about two weeks before the unblinding. This method resulted in 61 patients at smaller sites being “virtually ignored,” he said.
Without site stratification, InflaRx reported that vilobelimab demonstrated a statistically significant reduction in all-cause mortality. InflaRx said it has “encouraging interactions” with the FDA and announced plans to file an NDA as early as July.
Derval O’Carroll
InflaRx executives said they are currently in discussions with the FDA about filing for full approval, but it remains unclear if further studies are needed. Gohibic targets a protein called complement factor C5a to curb the body’s inflammatory response.
“I think you’ll see from the approval that the data we have is pretty solid, but we haven’t had those discussions yet,” Derval O’Carroll, VP and head of regulatory affairs, said on the conference call.
When asked if the company would consider a trading partner, Riedemann said all options were on the table.
“As a small biotech, we have to be relatively opportunistic. Again, if the idea is to get the drug to patients as quickly as possible, that wouldn’t preclude a partner who can do it faster than us,” he said.