FDA News

Cidara receives orphan drug status for antifungal to treat Candida infections

Cidara Therapeutics has received an orphan drug designation from the FDA for its antifungal drug candidate to treat life-threatening Candida infections, the company announced.

The novel echinocandin drug, CD101 IV, treats candidemia and invasive candidiasis, serious fungal infections associated with high mortality rates and rising drug resistance.

Cidara completed a phase 1 multiple ascending dose clinical trial of CD101 IV, and in January it reported excellent safety and tolerability across a broad range of doses. The company plans to conduct a phase 2 candidemia trial within the next 4 months.

Jeff Stein, PhD

Jeff Stein

According to Jeff Stein, PhD, CEO of Cidara, CD101 IV has an advantage over existing drugs in the same class because patients can receive a full week of therapy from one infusion and be discharged from the hospital earlier, potentially reducing costs and the number of nosocomial infections.

“Physicians can be assured that their patients will have a full week of drug on board without having to rely on their patients to either return to the hospital or clinic for a once-daily infusion or to take a once-daily pill for a week on an outpatient basis,” Stein told Infectious Disease News. “Inadequate compliance with oral anti-infectives is a contributing factor to relapse and the spread of resistant pathogens.”

Upon FDA approval, Cidara would gain 12 years of potential marketing exclusivity for CD101 IV — 7 years from the orphan drug designation in addition to the 5 years that came with the drug’s classification as a qualified infectious disease product in May 2015. Orphan drug designation will enable the company to fast-track development of the drug through more frequent interactions with the FDA, thereby potentially providing doctors with a safe and effective new therapy to treat and prevent Candida infections, Stein said. – by Gerard Gallagher

Cidara Therapeutics has received an orphan drug designation from the FDA for its antifungal drug candidate to treat life-threatening Candida infections, the company announced.

The novel echinocandin drug, CD101 IV, treats candidemia and invasive candidiasis, serious fungal infections associated with high mortality rates and rising drug resistance.

Cidara completed a phase 1 multiple ascending dose clinical trial of CD101 IV, and in January it reported excellent safety and tolerability across a broad range of doses. The company plans to conduct a phase 2 candidemia trial within the next 4 months.

Jeff Stein, PhD

Jeff Stein

According to Jeff Stein, PhD, CEO of Cidara, CD101 IV has an advantage over existing drugs in the same class because patients can receive a full week of therapy from one infusion and be discharged from the hospital earlier, potentially reducing costs and the number of nosocomial infections.

“Physicians can be assured that their patients will have a full week of drug on board without having to rely on their patients to either return to the hospital or clinic for a once-daily infusion or to take a once-daily pill for a week on an outpatient basis,” Stein told Infectious Disease News. “Inadequate compliance with oral anti-infectives is a contributing factor to relapse and the spread of resistant pathogens.”

Upon FDA approval, Cidara would gain 12 years of potential marketing exclusivity for CD101 IV — 7 years from the orphan drug designation in addition to the 5 years that came with the drug’s classification as a qualified infectious disease product in May 2015. Orphan drug designation will enable the company to fast-track development of the drug through more frequent interactions with the FDA, thereby potentially providing doctors with a safe and effective new therapy to treat and prevent Candida infections, Stein said. – by Gerard Gallagher