YARDLEY, PA — Savara Inc. (Nasdaq: SVRA) will present long-term efficacy and safety findings from its Phase 3 molgramostim trial Sept. 6 at the European Respiratory Society Congress in Barcelona, advancing the company’s case for a potential treatment for a rare lung disease with no approved drug therapy.
The clinical-stage biopharmaceutical company secured one oral presentation and two poster presentations covering findings from the IMPALA-2 trial in patients with autoimmune pulmonary alveolar proteinosis, or aPAP.
The oral presentation will examine the durability and safety of molgramostim during the first 48 weeks of the trial’s open-label period, when participants received the treatment. It is scheduled for 3:45 to 5 p.m. Central European Summer Time at Fira Gran Via.
Bruce C. Trapnell, the trial’s lead clinical investigator and a professor at the University of Cincinnati College of Medicine, will present the results.
Trapnell said the data indicate continued improvements in lung function, exercise capacity and quality of life, accompanied by reductions in biomarkers associated with disease severity.
“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,” Trapnell said.
The two posters will focus separately on exercise capacity and disease biomarkers. Cormac McCarthy of University College Dublin will present the exercise findings, while Yoshikazu Inoue of Japan’s NHO Kinki Chuo Chest Medical Center will present the biomarker analysis.
Both poster sessions are scheduled for 8 to 9:30 a.m. Central European Summer Time on Sept. 6.
Savara will also host an industry symposium that evening examining aPAP’s biological mechanisms and clinical management. The program will feature lung-disease specialists from Ireland, Italy, the Netherlands and France.
Autoimmune pulmonary alveolar proteinosis is caused by antibodies that neutralize granulocyte-macrophage colony-stimulating factor, or GM-CSF. That disruption prevents immune cells in the lungs from properly clearing excess surfactant from the alveoli.
The resulting accumulation can impair oxygen transfer and cause shortness of breath, coughing and fatigue. More serious complications can include lung infections, fibrosis and the need for a lung transplant.
The ERS Congress runs Sept. 5-9 in Barcelona.
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