Pulmocide Announces Termination of Opera-T Phase 3 Study with Opelconazole

Decision made after reviewing results of interim analysis

LONDON, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Pulmocide Ltd., (“the Company”), a late-stage biopharmaceutical company developing the investigational product, inhaled opelconazole, for patients suffering from serious acute and chronic respiratory diseases, today announced the decision to terminate its Opera-T Phase 3 Study with opelconazole in refractory Invasive Pulmonary Aspergillosis (IPA). This decision was based on an interim analysis for the purpose of a sample size recalculation when approximately 50% of the subjects had been randomized and had sufficient time to complete the 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 study enrolled patients who were severely immunocompromised, most of whom had a life threatening underlying hematological malignancy or were recipients of a stem cell or solid organ transplant. Based on data available at the time of the interim analysis, a large majority of patients had also failed at least two prior antifungal regimens for their IPA before enrolling into the study. Causality assessments conducted by investigators by the time of the interim analysis did not attribute any patient death to the blinded study drug. Pulmocide 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.

About Pulmocide
Pulmocide Ltd (www.pulmocide.com) is a late-stage biopharmaceutical company focused on the development of a novel inhaled azole therapy for patients at risk of developing serious complications associated with aspergillosis, such as immunocompromised patients and those with severe pulmonary diseases. The company is currently focused on acute and chronic treatments for pulmonary aspergillosis and its lead Phase 3 product opelconazole is being developed initially for the treatment of invasive pulmonary aspergillosis.

For further information, please contact:

Pulmocide Contact:
Jennifer Giottonini Cayer
Chief Business Officer and Head of Corporate Development
Pulmocide Ltd
jcayer@pulmocide.com

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