Savara Reports Molgramostim Benefits in Exploratory Lung Study

Savara

YARDLEY, PA — Savara Inc. (Nasdaq: SVRA) reported improvements in pulmonary gas transfer and lung imaging measures among patients with a rare respiratory disease who received its experimental drug molgramostim, according to a retrospective analysis presented at the recent CHEST 2026 Annual Meeting in Phoenix, Arizona.

The findings suggest a potential treatment benefit for patients with autoimmune pulmonary alveolar proteinosis (aPAP) whose lung diffusion capacity remains relatively normal, although the analysis involved only 11 patients and was not designed to establish definitive treatment efficacy.

The Yardley-based biopharmaceutical company presented the results from a subgroup of participants in IMPALA, a randomized, double-blind, placebo-controlled Phase 2/3 clinical trial conducted at 34 sites across 18 countries.

Of the trial’s 138 randomized patients, 13 had baseline lung diffusion capacity greater than 70% of the predicted value, indicating relatively preserved function on that measure.

The analysis included eight patients assigned to daily 300-microgram molgramostim and three assigned to placebo. Two additional patients receiving an intermittent dosing regimen were excluded because only daily treatment was advanced into the subsequent Phase 3 IMPALA-2 trial.

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Seven molgramostim recipients had complete data at Week 24.

Among patients receiving daily molgramostim, the mean alveolar-arterial oxygen gradient, a measure of gas transfer between the lungs and bloodstream, declined to 19.8 mmHg after 24 weeks from 32.5 mmHg at baseline.

That represented an improvement of 12.7 mmHg, compared with a 0.3 mmHg improvement among placebo recipients.

Chest computed tomography scans also indicated a reduction in lung abnormalities associated with accumulated surfactant.

Mean ground-glass opacity scores declined from 8.7 to 3.9 among molgramostim recipients, while scores increased slightly from 7.0 to 7.2 in the placebo group.

Patient-reported respiratory health measures showed a more mixed comparison.

The mean St. George’s Respiratory Questionnaire total score improved by 7.8 points among molgramostim recipients and 7.2 points among placebo recipients. Lower scores indicate better respiratory-related quality of life.

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On the questionnaire’s activity component, molgramostim recipients recorded an 11.1-point improvement, compared with 2.3 points in the placebo group.

Lung diffusion capacity was maintained among molgramostim-treated patients, whose baseline measurements were already near normal.

The analysis also found that patients with relatively preserved diffusion capacity nevertheless entered the trial with impaired pulmonary gas transfer, reduced respiratory-related quality of life and substantial surfactant accumulation.

Bruce C. Trapnell, a professor of medicine and pediatrics at the University of Cincinnati College of Medicine who presented the research, said the results suggest that conventional diffusion measurements may not fully reflect the disease burden experienced by some patients.

“Daily molgramostim was associated with improvements in each of these measures,” Trapnell said, while describing the findings as exploratory.

The analysis was conducted after the original trial and involved a small subgroup, limiting the conclusions that can be drawn from differences between the treatment and placebo groups.

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Savara characterized the findings as descriptive and hypothesis-generating rather than confirmatory evidence of efficacy.

Molgramostim remains an investigational treatment for aPAP. The company is developing the drug for a rare disease characterized by abnormal accumulation of surfactant material in the lungs, which interferes with respiratory function.

The findings add to Savara’s clinical research program following its Phase 3 IMPALA-2 trial, which evaluated the daily dosing regimen.

The company said the full research poster, identified as Poster 4315, will be available through the Congresses and Publications section of its corporate website.

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