Why was Pulmocide's Phase III opelconazole trial stopped?

The trial was stopped due to an interim analysis revealing a numerically higher mortality rate and a numerically lower favorable response rate in the opelconazole treatment group.

What is invasive pulmonary aspergillosis (IPA)?

IPA is a lung infection caused by the Aspergillus fungus, typically affecting severely immunocompromised individuals like cancer patients or transplant recipients.

What were the results of Pulmocide's Phase II OPERA-S trial?

The Phase II trial showed opelconazole was generally well-tolerated with few adverse events and showed promise in preventing and eradicating lung infections.

Home / Health / Pulmocide Trial Halted: Higher Mortality Rate Found

Pulmocide Trial Halted: Higher Mortality Rate Found

9 Jan

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Summary

Phase III trial of opelconazole for invasive pulmonary aspergillosis halted.
Interim analysis showed higher mortality and lower response rates.
Trial patients had severe immunocompromise and failed prior treatments.

Pulmocide Trial Halted: Higher Mortality Rate Found

Pulmocide has terminated its Phase III Opera-T trial (NCT05238116) investigating opelconazole for invasive pulmonary aspergillosis (IPA). The decision followed an interim analysis indicating a higher mortality rate among patients receiving opelconazole compared to the control arm. While deaths were not directly attributed to the study drug at the time of the analysis, the unfavorable trend prompted the halt.

The trial focused on severely immunocompromised individuals, many with hematological malignancies or post-transplant status, who had previously failed at least two antifungal regimens. These findings contrast with earlier Phase II results from April 2024 (NCT05037851), which suggested opelconazole was generally well-tolerated with a low incidence of adverse events and demonstrated potential in preventing and eradicating lung infections.

Pulmocide is now conducting a further review of the unblinded data to decide the future of the opelconazole program. The company had previously secured $147.5 million in funding across 2021 and 2022 to advance its development. Pulmonary aspergillosis remains a serious condition, with current treatments including antifungals and steroids.