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SVRA 資訊
SVRA 事件
Savara Presents IMPALA-2 Trial Data at ERS Congress in Barcelona
Savara announced the acceptance of one oral presentation and two poster presentations on data from the Phase 3 IMPALA-2 clinical trial at the ERS Congress in Barcelona, Spain, September 5-9, 2026. "Collectively, these data show that molgramostim continues to improve lung function, exercise capacity, and quality of life in patients, while reductions in biomarkers of aPAP lung disease severity suggest it may normalize the underlying pathobiology," said Bruce C. Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine and the Lead Clinical Investigator of the IMPALA-2 clinical trial. "Combined with the high retention rate in the trial and durability of effect we've now seen through the first 48-weeks of the IMPALA-2 open-label period, these results strongly support molgramostim's potential as an effective long-term option for a patient population with no approved pharmacologic treatments. We look forward to sharing these data at the ERS Congress."
Savara CEO Highlights U.S. Launch Opportunity for MOLBREEVI
"While we have regulatory applications under review across the U.S., EU, and U.K., the U.S. represents our nearest-term opportunity," said Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer, Savara. "Our focus is on the potential launch of MOLBREEVI in the U.S., supported by a strong balance sheet to ensure commercial readiness."
Savara Secures Patent for Molbreevi Liquid Formulation
Savara announced that the European Patent Office, EPO, has granted a patent covering the liquid formulation of Molbreevi, an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor. European patent No.4121000 provides protection for Molbreevi through March 2041. Separately, the Australian Patent Office has also granted a patent covering the liquid formulation of Molbreevi, and securing protection in Australia through the same date. "These patents further strengthen the Company's intellectual property portfolio for Molbreevi, providing an additional layer of defense in markets with no approved alternatives," said Kate McCabe, Chief Legal Officer, Savara. "Together, these patents reflect the strength of our liquid formulation IP across key ex-US markets. In parallel, we are advancing equivalent patent filings in the U.S., including a patent for the drug-device combination, with the aim of securing comprehensive protection across major commercial territories."
Palvella Therapeutics Appoints Matt Pauls to Board of Directors
Palvella Therapeutics (PVLA) announced the appointment of Matt Pauls to its board of directors. Since 2020, he has served as chair of the board of directors and CEO of Savara (SVRA).
Savara Presents New Data on Molgramostim at ATS 2026 Conference
Savara presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reported new biomarker data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. Poster Board 401: "Relationship Between Pulmonary Gas Transfer and Biomarker Levels in Patients with Autoimmune Pulmonary Alveolar Proteinosis." Presented serum biomarker data from IMPALA-2, a Phase 3 clinical trial in which aPAP patients received nebulized molgramostim 300 microgram or placebo once daily for 48 weeks. Blood samples were collected at baseline and at Weeks 4, 12, 24, and 48, measuring levels of Krebs von den Lungren protein-6, cytokeratin 19 fragments, carcinoembryonic antigen, lactate dehydrogenase, hemoglobin, and hematocrit. Molgramostim significantly improved pulmonary gas transfer, as measured by change from baseline in percent predicted diffusing capacity of the lungs for carbon monoxide adjusted for hemoglobin at Week 24 and Week 48 versus placebo. Post-hoc analyses showed that patients in the molgramostim group also demonstrated significantly greater mean decreases from baseline in LDH, and KL-6 compared with placebo. Strong correlations were observed in the overall study population between improvements in DLco% and decreases in LDH. Conclusions: Biomarker levels associated with aPAP disease severity decreased in patients treated with molgramostim. Additionally, decreased levels of biomarkers were associated with improvements in pulmonary gas transfer.
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