Savara to Modify Molgradex Study

Savara said Wednesday it is modifying its endpoint hierarchy and statistical analyses of the ongoing study of Molgradex for the treatment of a form of autoimmune pulmonary disease based on feedback from the US Food and Drug Administration. The feedback was centered on the FDA’s clinical program requirements for a new drug application. The modifications will help the study qualify as a pivotal phase 3 study in the US.

Molgradex is an inhaled formulation of recombinant human GM-CSF, for the treatment of autoimmune pulmonary alveolar proteinosis, or PAP. B Patient enrollment is expected to be completed by the first quarter of 2018, and top line data is expected to be available by the fourth quarter of 2018, the company said. The shares fell 2.5% on Wednesday morning.

By Celina Yao