Pulmocide announced that the Phase 2 OPERA-S study of PC945 inhaled opelconazole in lung transplant patients demonstrated that the inhalation suspension was generally safe and well tolerated, with no subjects needing to discontinue or reduce medications due to interactions with immunosuppressant drugs. Pulmocide is developing PC945, which has been granted orphan drug, Fast Track, and Qualified Infectious Disease Product designations, for the prevention and treatment of pulmonary aspergillosis.
In the open-label OPERA-S trial, 102 lung transfer patients were randomized 2:1 to recieve either inhaled opelconazole or standard of care antifungal therapy, with treatment starting within 72 hours of transplantation and lasting for up to 12 weeks. In addition to the safety results, Pulmocide announced some efficacy results. According to Pulmocide, opelconazole eradicated Aspergillus and Candida infections in most of the patients who were already colonized when they entered the study.
Pulmocide Chief Medical Officer Lance Berman commented, “The data support that inhaled opelconazole was generally safe and well tolerated in this study when administered as monotherapy prophylaxis in lung transplant patients, a critically ill patient population with major pulmonary morbidity. Based on discussions with clinicians who care for lung transplant patients, it appears that a potent antifungal agent delivered directly to the lungs with a low discontinuation rate and a negligible risk for DDIs [drug-drug interactions] would be a promising alternative. We believe that the use of opelconazole as a prophylaxis agent in patients at risk of pulmonary aspergillosis warrants further investigation.”
Read the Pulmocide press release.
