Orphan Drug Designation Granted to Novel Echinocandin
Cidara Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to CD101 IV for the treatment of candidemia and invasive candidiasis.
A recent Phase 1 multiple ascending dose (MAD) clinical trial demonstrated an excellent safety and tolerability profile for CD101 IV across a broad range of doses. Cidara intends to initiate a Phase 2 clinical trial in patients with candidemia in the first half of 2016.
CD101 IV is a novel, long-acting echinocandin antifungal under development for the treatment and prevention of serious fungal infections that are associated with high mortality rates and rising drug resistance.
For more information call (858) 752-6170 or visit Cidara.com.