A recent study has highlighted the promising results of a new inhaled antifungal medication, opelconazole

The Phase 2 OPERA-S study, focusing on the safety and tolerability of inhaled opelconazole, explored its effectiveness as a prophylactic against pulmonary aspergillosis in patients who had undergone lung transplants. Conducted by Pulmocide Ltd., this trial involved 102 participants and aimed to compare inhaled opelconazole with standard care antifungal prophylaxis.

Participants were randomly assigned to two groups at a 2:1 ratio—one receiving opelconazole and the other following standard antifungal treatments. The study spanned over 12 weeks, monitoring several parameters, including adverse events (AEs), drug-drug interactions (DDIs) and treatment discontinuations. Opelconazole showed a favorable safety profile, with fewer drug-related AEs and DDIs compared to standard care, which contributes to its potential as an effective prophylaxis.

Specifically, drug-related adverse events such as cough, nausea, and respiratory tract irritation occurred in less than 7% of opelconazole patients. These events were generally mild to moderate and rarely led to treatment discontinuation. Discontinuation due to AEs and DDIs was notably lower in the opelconazole group (7.7%) compared to the standard care group (27.3%). Most patients on opelconazole (72.3%) completed the full 12 weeks of prophylaxis, slightly higher than those on standard care (69.7%).

Efficacy in preventing pulmonary fungal infections was also measured. The infection rates were low and comparable between both groups, with 4% in the opelconazole group and 3% in the standard care group. Interestingly, opelconazole effectively eradicated Aspergillus and Candida colonization in a majority of colonized patients at study entry. This highlights its potential efficacy as a prophylaxis option.

Dr. Lance Berman, Chief Medical Officer of Pulmocide, emphasized that opelconazole's tolerability and safety in a patient group with significant pulmonary issues are promising. Dr. Shahid Husain from the University of Toronto, involved in the study, echoed these sentiments, noting the importance of maintaining potent antifungal therapy without compromising necessary immunosuppressive treatments.

Further comprehensive results from this study will be presented at medical conferences and peer-reviewed publications in the future.

Opelconazole, a novel inhaled antifungal agent developed by Pulmocide, aims to maximize lung-specific effects with minimal systemic exposure, potentially reducing toxicities and drug-drug interactions associated with systemic treatments. It's designed for treating conditions like chronic pulmonary aspergillosis, severe asthma with allergic bronchopulmonary aspergillosis, and complex flu or COVID-19 cases involving invasive aspergillosis. Additionally, it shows promise as a prophylactic option for immunocompromised patients.

Pulmocide Ltd. is a late-stage biopharmaceutical company committed to developing advanced inhaled therapies for serious respiratory conditions, particularly targeting aspergillosis.