Pulmocide halts Phase 3 trial of Opelconazole in severe lung infection
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Pulmocide halts Phase 3 trial of Opelconazole in severe lung infection

The decision follows an interim analysis conducted when roughly half of the patients had completed their Day 84 visit

  • By IPP Bureau | January 11, 2026
Pulmocide, a late-stage biopharmaceutical company developing inhaled opelconazole for serious respiratory diseases, has announced that it is terminating its Opera-T Phase 3 study in refractory Invasive Pulmonary Aspergillosis (IPA), a severe lung infection.
 
The decision follows an interim analysis conducted when roughly half of the patients had completed their Day 84 visit. “The analysis showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm,” the company said.
 
The study enrolled severely immunocompromised patients, most with life-threatening hematological malignancies or recipients of stem cell or solid organ transplants. A large majority had already failed at least two prior antifungal treatments for IPA before joining the trial.
 
Pulmocide noted that “causality assessments conducted by investigators by the time of the interim analysis did not attribute any patient death to the blinded study drug.”
 
The company added it will “be conducting a thorough review of the unblinded data from this trial to determine potential next steps for the program and would like to sincerely thank all the patients and investigators for participating in the study.”

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