The Cystic Fibrosis Foundation announced that it is providing $3.5 million for a Phase 2 study of Pulmocide Ltd’s PC945 inhaled opelconazole for the prevention of pulmonary Aspergillus infections following lung transplantation. The CF Foundation noted that this is the organization’s first investment in development of a drug specifically for treatment related to lung transplants.
In September 2021, Pulmocide announced that the FDA had granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations for PC945 for the treatment of invasive pulmonary aspergillosis (IPA). The company’s web site indicated that it intended to initiate a Phase 3 trial of PC945 for the treatment of IPA by the end of 2021.
According to the study record on clinicaltrials.org, the open-label Phase 2 trial is anticipated to enroll 100 adult lung transfer patients and is currently recruiting. Subjects will receive either twice-daily nebulized opelconazole or standard of care over 12 weeks, with the goal of determining how many patients are able to complete the full 12 weeks of therapy.
CF Foundation VP of Clinical Affairs Albert Faro commented, “This is exciting news for the entire CF community. We are hopeful not only that this potential treatment could help prevent lung transplant recipients from getting a devastating Aspergillus infection, but also that if successful, it could eventually help all people with CF who have chronic Aspergillus infections.”
Read the CF Foundation press release.