Savara Reports Positive Phase 3 Molgramostim Nebulizer Solution (Molgramostim) Clinical Trial Results

June 26, 2024

DENVER, Colo., Jun 26, 2024 (247marketnews.com)- Savara Inc. (Nasdaq:SVRA) reported positive Phase 3 IMPALA-2 clinical trial results, from its 48-week, randomized, double-blind, placebo-controlled trial, which met its primary endpoint.

Bruce Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine and the Lead Clinical Investigator of the IMPALA-2 trial, stated, “There is a high unmet need for effective, disease-specific pharmacotherapy for autoimmune PAP.”

Trapnell continued, “Patients typically experience breathlessness, which begins slowly and progresses over time, often accompanied by cough and fatigue, and in some patients, serious infections, pulmonary fibrosis, and respiratory failure requiring lung transplantation. With convincing data from two large clinical trials, the evidence now clearly demonstrates molgramostim has the potential to be a safe and efficacious treatment option for these patients. This is a momentous day for the aPAP community.”

Savara’s Chair and CEO, Matt Pauls, commented, “The IMPALA-2 results not only met, but exceeded, our expectations, validating our hypothesis that molgramostim provides clear, durable improvement in gas exchange, and beyond that, clinical benefits that positively impact quality of life for aPAP patients.”

Pauls continued, “The strong efficacy data and favorable benefit-risk profile potentially position molgramostim to be the first and only approved therapeutic for aPAP in the U.S. and Europe. We extend our gratitude to the patients and their families, clinicians, and site personnel for their contributions and ongoing participation in the largest clinical trial in aPAP. We look forward to analyzing the full data from IMPALA-2 and anticipate submitting it for presentation at a scientific conference later this year.”

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