Pulmocide has announced evidence of prevention of pulmonary aspergillosis with pipeline candidate opelconazole after releasing topline data from a Phase II trial.

The company has announced topline results from the OPERA-S trial (NCT05037851) which investigated inhaled opelconazole in lung transplant patients as prevention against pulmonary aspergillosis.

In the open-label, active-controlled trial enrolled 102 patients who were randomised in the ICU after receiving a lung transplant in a 2:1 ratio to either inhaled opelconazole or standard of care (SOC) antifungal prophylaxis and were treated for up to 12 weeks.

Opelconazole was generally well tolerated with a low incidence of drug-related adverse events (AEs) and a low incidence of treatment-limiting respiratory AEs. Respiratory AEs related to opelconazole led to discontinuation in two out of 65 opelconazole patients.

There were no dose reductions or discontinuations of opelconazole prophylaxis or immunosuppressant medications due to drug-drug interactions (DDIs).

There was also evidence of prevention of pulmonary aspergillosis and eradication in the lungs of both aspergillus and candida colonisation with opelconazole monotherapy.

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Dr. Lance Berman, chief medical officer of Pulmocide said: “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 would be a promising alternative.”

Opelconazole is an investigational inhaled triazole antifungal being developed to prevent and treat pulmonary aspergillosis. Opelconazole has the potential to be useful in a variety of conditions including chronic pulmonary aspergillosis, severe asthma complicated by allergic bronchopulmonary aspergillosis, and severe flu or COVID-19 complicated by invasive aspergillosis.

Pulmocide is also running a Phase III trial of the candidate in combination with other antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis (NCT05238116).

Pulmonary aspergillosis landscape

Pulmonary aspergillosis is a term used to describe various types of lung infections caused by the fungus aspergillus. These infections can range from mild to severe and can affect patients with compromised immune systems, such as those undergoing treatment for haematologic cancers or organ transplantation.

Current treatment options include oral steroids, which are commonly used to treat allergic bronchopulmonary aspergillosis (ABPA), or oral antifungals which are used to treat both ABPA and other forms of pulmonary aspergillosis.