LANGHORNE, PA — Savara (Nasdaq: SVRA) reported long-term Phase 3 trial data showing continued improvements in lung function and respiratory quality of life among patients receiving molgramostim for autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease, as the company advances its lead therapy toward potential commercialization.
The data, presented at the ATS 2026 International Conference in Orlando, Florida, came from the ongoing open-label extension of the IMPALA-2 Phase 3 study, which enrolled 164 patients and is the largest and longest clinical trial conducted in aPAP, according to the company.
All 160 patients who completed the trial’s 48-week double-blind phase elected to continue into the open-label treatment period, where all participants received molgramostim. As of the data cutoff date, nine patients had discontinued treatment, resulting in a 94% retention rate.
The findings showed patients who received molgramostim during both the double-blind and open-label phases continued to improve measures of pulmonary gas transfer and respiratory health-related quality of life through 96 weeks.
Patients who initially received placebo and later switched to molgramostim also experienced gains after beginning active treatment.
Pulmonary gas transfer was measured using percent predicted diffusing capacity of the lungs for carbon monoxide, or DLco%. By Week 48 of the double-blind phase, patients receiving molgramostim recorded an average improvement of 11.6 percentage points from baseline, compared with 3.9 percentage points among placebo recipients.
During the subsequent open-label period, patients who remained on molgramostim achieved an overall average DLco% improvement of 14.7 percentage points from baseline through Week 96. Patients who crossed over from placebo to molgramostim improved by an average of 8.8 percentage points during Weeks 48 through 96.
The study also tracked respiratory quality of life using the St. George’s Respiratory Questionnaire. Lower scores indicate better outcomes.
Patients treated continuously with molgramostim achieved overall improvements from baseline of 15.0 points on the total score and 18.3 points on the activity score through Week 96. Patients who switched from placebo to molgramostim also demonstrated meaningful reductions in both measures during the open-label phase.
Bruce Trapnell, lead clinical investigator for IMPALA-2 and a professor of medicine and pediatrics at the University of Cincinnati College of Medicine, said the results suggest sustained benefits from longer-term treatment.
“We are pleased to see that after longer-term drug exposure, the MOL-MOL patients showed continuous improvements in efficacy and quality of life, and the PBO-MOL patients showed improvements in the same outcome measures while receiving molgramostim during the OL treatment period,” Trapnell said.
He added that the high patient retention rate and safety profile observed during the extension phase were consistent with prior findings and support the therapy’s long-term use.
Safety results from the first 48 weeks of the open-label period were generally consistent with those reported during the double-blind phase. The company reported no study discontinuations resulting from treatment-related adverse events.
The ongoing open-label extension is scheduled to continue for a total of 96 weeks.
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