Pulmocide announced that the FDA has granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations for its PC945 inhaled opelconazole for the treatment of invasive pulmonary aspergillosis (IPA). Pulmocide launched in 2013 to develop inhaled anti-fungal therapies, and PC945 is its sole product.
According to the company’s web site, nebulized opelconazole is 30-100 times more effective against aspergillus fumigatus than voriconazole. A Phase 3 trial of PC945 in patients with IPA and few or no other treatment options is expected to begin sometime this year.
Pulmocide Chairman and CEO Daniel Burgess said, “The FDA’s decision to grant opelconazole Orphan Drug, Fast Track and QIDP designations acknowledges the serious unmet medical need associated with IPA and is a significant milestone in our effort to develop a treatment for IPA, a rare and debilitating disease, with less than 50% of patients responding well to first line standard of care. We look forward to continuing to work closely with the FDA to advance this important medicine.”
Read the Pulmocide press release.
