Pulmocide Halts Phase III Trial of Opelconazole After Interim Safety Signal

Pulmocide has discontinued its Phase III Opera-T trial evaluating inhaled antifungal opelconazole in patients with refractory invasive pulmonary aspergillosis, following an interim analysis that raised safety concerns. The review showed a numerically lower favourable response rate and a higher mortality rate among patients receiving opelconazole compared with the control group.

The London-based company said investigators did not attribute any deaths directly to the blinded study drug at the time of analysis. The interim review was initially planned to reassess sample size after about half of the participants had been enrolled.

The study population consisted of severely immunocompromised patients, many with life-threatening blood cancers or prior stem cell or organ transplants, and most had failed at least two previous antifungal therapies.

Pulmocide plans to further analyse unblinded trial data to determine next steps for the programme. Opelconazole had previously shown encouraging safety and activity in a Phase II study.

12-01-2026