Pulmocide’s phase 3 trial has been cancelled after patients who received its investigational inhaled antifungal had lower response rates and a higher number of deaths than those in the control arm.
The decision was based on an interim analysis of the phase 3 Opera-T study, conducted after around half of the patients had beens and had reached day 84 of treatment. This analysis was done to recalculate the trial’s sample size.
The London-based biotech was trialing opelconazole, a nebulized azole compound, in treatment-resistant invasive pulmonary aspergillosis. Aspergillosis is an infection of the lungs caused by mould in the genus Aspergillus, and is most common in patients with compromised immune systems, like those who have received lung transplants.
In the most severe invasive form of the infection, the fungus has spread from the lungs to other parts of the body, such as the skin, brain, heart or kidneys.
Opera-T was set to enroll around 123 patients and compare twice-daily opelconazole and placebo in patients also being treated with other antifungals. Enrolled patients were “severely immunocompromised,” Pulmocide said in the release, “most of whom had a life-threatening underlying hematological malignancy or were recipients of a stem cell or solid organ transplant.”
Based on the analysis, most of the patients’ disease had not responded to at least two earlier antifungal treatments before joining the study, the British biotech added.
None of the undisclosed number of patient deaths were attributed to opelconazole itself.
