Savara Inc.’s (Nasdaq: SVRA) experimental drug molgramostim improved patient exercise capacity in a Phase 3 trial, with users walking an average of 80.6 meters farther than those on placebo after 48 weeks.
"We believe the consistency in improvements observed across both exploratory endpoints—distance walked and exercise duration—and our secondary endpoint of exercise capacity... strengthens the overall efficacy picture," Yasmine Wasfi, Chief Medical Officer at Savara, said in a statement. "Taken together, these data suggest that molgramostim may translate into real-world functional benefits for aPAP patients."
The new data from the global IMPALA-2 study, presented at the American Thoracic Society 2026 International Conference, showed patients receiving molgramostim had a least-squares mean improvement in walking distance of 167.0 meters, compared to 86.4 meters for placebo (P=0.0301). Exercise duration also increased by a statistically significant mean of 1.0 minute over the placebo group (P=0.0262).
The positive results for these exploratory endpoints bolster previously announced significant results for the trial's primary endpoint. The findings could support a future regulatory submission for the drug as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease where the abnormal buildup of surfactant in the lungs impairs breathing.
Molgramostim, a recombinant form of human granulocyte-macrophage colony-stimulating factor (GM-CSF), is designed to help immune cells clear the excess surfactant. In aPAP, the body’s own antibodies neutralize natural GM-CSF, leading to symptoms like shortness of breath, cough, and fatigue. The drug is delivered via a proprietary eFlow Nebulizer System.
The data suggests a tangible functional benefit for patients with aPAP, a condition with limited treatment options. Investors will now look toward a potential Biologics License Application with the U.S. Food and Drug Administration as the next major catalyst for the company.
This article is for informational purposes only and does not constitute investment advice.
