Savara has completed the enrolment of patients in the Phase III IMPALA-2 trial of the molgramostim nebuliser solution for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease.
The international, pivotal, double-blind, placebo-controlled, randomised study is designed to compare the safety and efficacy of molgramostim 300mcg against placebo in patients with aPAP.
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It is being conducted at nearly 50 clinical trial sites across 18 countries including Europe, Japan, North America, Australia, and South Korea.
The study enrolled a total of 164 patients against the target enrolment of 160 patients. They will receive a daily once-inhaled dose of 300mcg molgramostim for 48 weeks.
Change from baseline in per cent predicted by a gas exchange measure for diffusing capacity of carbon monoxide is the primary efficacy variable of the trial.
Evaluating clinical measures of direct patient benefit using St George’s Respiratory Questionnaire (SGRQ) Total Score, SGRQ Activity Component Score, and exercise capacity using a treadmill test are the secondary efficacy variables.
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By GlobalDataEvaluation of safety and efficacy of the solution will be carried out through week 48 while the primary time point for efficacy is at week 24.
Top-line data from the trial is anticipated by the end of the second quarter of next year.
Savara chair and CEO Matt Pauls said: “Enrolment completion marks an important milestone in the molgramostim development programme.
“We believe over-enrolment in the trial, on-time, during the Covid-19 pandemic speaks directly to both the high unmet need within this patient population and the therapeutic potential of molgramostim.”
Molgramostim is an inhaled granulocyte-macrophage colony-stimulating factor that is delivered using an investigational eFlow nebuliser system developed by PARI Pharma.
