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Savara expands enrollment in late-stage PAP study of Molgradex, top-line data expected in Q2 2019; shares up 3%

Published 02/12/2018, 11:33 AM
© Reuters. Savara expands enrollment in late-stage PAP study of Molgradex, top-line data expected in Q2 2019; shares up 3%
SVRA
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  • The FDA has signed off on Savara's (SVRA +2.6%) IND for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating (GM-CSF), for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), a rare lung disorder in which pulmonary surfactant accumulates in the alveoli (tiny air sacs in the lungs) interfering with oxygen/carbon dioxide exchange.
  • The IND enables the company to expand enrollment in the Phase 3 IMPALA study to 135 from 90, expected to be completed by Q3. Top-line results should be available by Q2 2019.
  • Alveolar cells called macrophages need to be stimulated by GM-CSF in order to effectively clear surfactant. In PAP, GM-CSF is neutralized by antibodies.
  • Now read: Regenxbio: Bullish Thesis Strengthens And Catalysts On The Way


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