Savara Inc. a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that enrollment has been completed for the pivotal Phase 3 IMPALA-2 trial. A total of 164 patients were randomized. Target enrollment for the trial was 160 patients. The Company expects to report top line results by the end of 2Q 2024. IMPALA-2 is a global, 48-week, placebo-controlled clinical trial evaluating molgramostim, a novel inhaled biologic, for the treatment of aPAP, a rare lung disease with no approved pharmacological treatments.

“Enrollment completion marks an important milestone in the molgramostim development program,” said Matt Pauls, Chair and CEO, Savara. “We believe over-enrollment 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. We anticipate reporting top line safety and efficacy data by the end of 2Q 2024.”

In December 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for molgramostim in aPAP based on data from the double-blind treatment period of the Phase 2/3 IMPALA clinical trial. Initiation of IMPALA-2 was based on results from IMPALA which were published in the New England Journal of Medicine in September 2020. In 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted Promising Innovative Medicine (PIM) designation and Innovative Passport Designation to molgramostim for the treatment of aPAP.

Source:savarapharma.com