Pivotal Phase 3 Clinical Study

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Pivotal Phase 3 Clinical Study

MOLGRAMOSTIM (inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF) is being evaluated for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).

MOLGRAMOSTIM NEBULIZER SOLUTION (MOLGRAMOSTIM) – aPAP

Molgramostim nebulizer solution (molgramostim) is the first inhaled GM-CSF being developed for the treatment of a rare respiratory disease called autoimmune pulmonary alveolar proteinosis (aPAP). A phase 3 clinical study, called IMPALA, was completed in 2019. The press release announcing results from the 24-week, double-blind period of the study can be found here. The press release announcing results from the open-label period can be found here. In September 2020, results from the study were published in the New England Journal of Medicine.

A second study of molgramostim in aPAP, called IMPALA-2, is anticipated to start by the end of 2Q or early 3Q 2021. IMPALA-2 is a pivotal Phase 3 study that is expected to be conducted at ~50 sites across the U.S., Canada, Japan, South Korea and countries in Europe. For more information on IMPALA-2, please click on the “read more” button below.
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