San Diego antifungal player nabs priority review for bloodstream infection treatment
Cidara Therapeutics wants to make its mark in the world of antifungals, and thanks to the FDA, it may get there soon.
The San Diego-based company announced Tuesday that the FDA has given priority review to its antifungal rezafungin for the treatment of candidemia and invasive candidiasis — common causes of serious bloodstream infections in hospitalized patients, per the CDC. No new therapies have been approved in over a decade for the two infections, the company said in a press statement. Rezafungin’s review deadline date is set for March 22, 2023.
The new drug submission was based on results from its global ReSTORE Phase III and STRIVE Phase II trials, which showed the drug’s non-inferiority over caspofungin, the current standard of care.
“If approved, rezafungin would represent an important new treatment option for patients at risk of these potentially deadly diseases,” said Cidara’s CEO Jeffrey Stein.
Meanwhile, the company is currently conducting a second Phase III study to examine the drug as a prophylactic for invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation.
In July 2022, the company struck a license agreement with Melinta Therapeutics, granting the latter an exclusive license to commercialize rezafungin in the US.
“This transaction eliminates the need for Cidara to build commercial infrastructure to launch rezafungin in the U.S.,” Stein said in a July 27 press statement.
The company licensed the drug to Mundipharma for other parts of the world except for Japan, where Cidara continues to hold the rights.
A few other companies are also developing antifungals. One of those, New Jersey-based biotech Scynexis, is developing its drug ibrexafungerp to fight fungal infections in a hospital setting.