Savara’s inhaled therapy molgramostim scores pivotal study win for rare lung disease

26 Jun 2024
firstwordpharma.com
Phase 3Clinical Result
Savara announced Wednesday that a Phase III study of molgramostim in adults with autoimmune pulmonary alveolar proteinosis (aPAP) met its primary endpoint, with CEO Matt Pauls saying the results “not only met, but exceeded, our expectations.” Pauls added that the data “potentially position molgramostim to be the first and only approved therapeutic for aPAP in the US and Europe.”
The IMPALA-2 trial randomised 164 people with aPAP to receive molgramostim once daily by inhalation or matching placebo. The study’s primary endpoint is change from baseline to week 24 in percent predicted diffusing capacity of the lungs for carbon monoxide DLCO, while secondary goals include change from baseline to week 48 in percent predicted DLCO.
Results showed that the treatment difference between molgramostim – an inhaled form of recombinant human GM-CSF – and placebo for mean change from baseline to week 24 in haemoglobin-adjusted percent predicted DLCO achieved statistical significance, which was maintained at week 48.
Savara added that molgramostim was well tolerated in the trial, with the frequency of adverse events (AEs) similar between the treatment groups. Two patients discontinued molgramostim treatment due to AEs, both of which were considered unrelated to the drug.
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