Savara Announces Results of IMPALA, a Phase 3 Study of Molgradex for the Treatment of Autoimmune Alv | INSM Message Board Posts

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Msg  46228 of 46388  at  6/12/2019 4:07:54 PM  by

tippy1


Savara Announces Results of IMPALA, a Phase 3 Study of Molgradex for the Treatment of Autoimmune Alveolar Pulmonary Proteinosis (aPAP)

  • The study did not meet its primary endpoint of alveolar-arterial oxygen gradient (A-aDO2)
  • The study showed statistically significant improvement in the St. George’s Respiratory Questionnaire (SGRQ), a key secondary endpoint
  • Adverse event frequencies were similar between the treatment arms and placebo
  • Company plans to meet with regulatory authorities in the coming months to discuss results from the study and a path forward
  • Management to host conference call today at 5:30 p.m. ET

Savara Inc. (SVRA), an orphan lung disease company, today announced top line data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP. 138 patients were randomized and received treatment for 24 weeks in one of three arms: 1) Molgradex 300 µg administered once daily continuously over 24 weeks, 2) Molgradex 300 µg, and matching placebo, administered once daily in 7-day intermittent cycles of each, or 3) inhaled placebo administered once daily continuously over 24 weeks." data-reactid="29" style="color: #26282a; font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; font-size: 15px; background-color: #ffffff;">Savara Inc. (SVRA), an orphan lung disease company, today announced top line data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP. 138 patients were randomized and received treatment for 24 weeks in one of three arms: 1) Molgradex 300 µg administered once daily continuously over 24 weeks, 2) Molgradex 300 µg, and matching placebo, administered once daily in 7-day intermittent cycles of each, or 3) inhaled placebo administered once daily continuously over 24 weeks.



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Replies
Msg # Subject Author Recs Date Posted
46231 Re: Savara Announces Results of IMPALA, a Phase 3 Study of Molgradex for the Treatment of Autoimmune Alveolar Pulmonary Proteinosis (aPAP) insmhistorian 0 6/12/2019 4:35:59 PM
46233 Re: Savara Announces Results of IMPALA, a Phase 3 Study of Molgradex for the Treatment of Autoimmune Alveolar Pulmonary Proteinosis (aPAP) b_leaguered 4 6/12/2019 9:33:42 PM


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