LANGHORNE, PA — Savara (Nasdaq: SVRA) reported new Phase 3 clinical trial data showing patients treated with its experimental inhaled therapy molgramostim achieved greater improvements in exercise capacity than those receiving placebo, adding to evidence supporting the drug’s potential use in a rare autoimmune lung disease.
The findings, presented at the American Thoracic Society 2026 International Conference in Orlando, come as the company advances molgramostim as a potential treatment for autoimmune pulmonary alveolar proteinosis (aPAP), a rare disorder that impairs the lungs’ ability to clear surfactant and exchange oxygen efficiently.
The data were drawn from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 study involving 164 adults with aPAP. Participants received either inhaled molgramostim or placebo once daily for 48 weeks.
Researchers reported that patients treated with molgramostim experienced greater gains in both walking distance and exercise duration compared with the placebo group.
At week 48, patients receiving molgramostim increased the distance walked during treadmill testing by an average of 167 meters from baseline, compared with 86.4 meters among placebo recipients. The treatment difference of 80.6 meters was statistically significant.
The study also found that molgramostim-treated patients exercised longer than those receiving placebo. Average exercise duration increased by 2.0 minutes in the treatment group versus 1.0 minute in the placebo group, producing a statistically significant treatment difference of one minute.
The exercise findings build on previously reported results from IMPALA-2, which met its primary endpoint and demonstrated improvements in peak metabolic equivalents, a measure commonly used to assess exercise capacity.
“We believe the consistency in improvements observed across both exploratory endpoints—distance walked and exercise duration—and our secondary endpoint of exercise capacity, as measured by peak METs, strengthens the overall efficacy picture,” said Dr. Yasmine Wasfi, Savara’s chief medical officer.
“Taken together, these data suggest that molgramostim may translate into real-world functional benefits for aPAP patients,” Wasfi added.
Autoimmune pulmonary alveolar proteinosis is a rare disease in which abnormal accumulation of surfactant material in the lungs can cause progressive shortness of breath, reduced exercise tolerance, and respiratory impairment.
Savara is developing molgramostim as an inhaled therapy intended to address the underlying biological dysfunction associated with the disease. The company has not yet disclosed a regulatory filing timeline based on the data presented.
The results were presented by Dr. Bruce C. Trapnell during an oral session at the conference and represent additional analyses from the completed double-blind portion of the IMPALA-2 trial.
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