Savara's Phase 3 IMPALA-2 Trial Of Molgramostim Met Statistical Significance For Primary Endpoint And Multiple Secondary Endpoints In Autoimmune Pulmonary Alveolar Proteinosis
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Biotechnology: Pharmaceutical Preparations
Health Care
- Statistically Significant Improvement in Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Versus Placebo at Week 24 (Primary Endpoint) and Week 48 (Secondary Endpoint).
- Statistically Significant Improvement in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24 (Secondary Endpoint).
- 97% of Patients Completed Double-Blind Treatment Through Week 48 with No Trial Drug Related Adverse Events Leading to Discontinuation.
- 100% of Patients Completing the 48-Week Double-Blind Period Elected to Participate in the 96-Week Open-Label Period.
- Company Plans to Complete BLA Submission in 1H 2025.