Pulmocide has announced the termination of the Opera-T Phase 3 study of opelconazole inhalation suspension in patients with invasive pulmonary aspergillosis. According to the company, an interim analysis found that patients receiving opelconazole had poorer outcomes and a higher mortality rate than the control group, leading them to stop the study. The company says that it “will be conducting a thorough review of the unblinded data from this trial to determine potential next steps for the program.”
In April 2024, Pulmocide announced that the Phase 2 OPERA-S trial demonstrated that the inhalation suspension was generally safe and well tolerated in lung transplant patients. The inhaled opelconazole, which is Pulmocide’s sole product, has received orphan drug, Fast Track, and Qualified Infectious Disease Product designations for the prevention and treatment of pulmonary aspergillosis. Development of the drug has been supported by the Cystic Fibrosis Foundation and Johnson & Johnson Innovation, among other investors.
Pulmocide notes that, “The study enrolled patients who were severely immunocompromised, most of whom had a life threatening underlying hematological malignancy or were recipients of a stem cell or solid organ transplant. Based on data available at the time of the interim analysis, a large majority of patients had also failed at least two prior antifungal regimens for their IPA before enrolling into the study. Causality assessments conducted by investigators by the time of the interim analysis did not attribute any patient death to the blinded study drug. “
Read the Pulmocide press release
