Savara files IND for Molgradex study

Savara has submitted an investigational new drug application for Molgradex inhaled recombinant human GM-CSF for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) to the FDA, the company said.

In May 2017, the company said that it planned to modify the Phase 2/3 IMPALA study of Molgradex for PAP in accordance with FDA advice in order to allow the study to serve as a pivotal study for a US regulatory submission.

According to Savara, the IND submission is part of a strategy to add US sites to the study and to enroll patients in the US as well as the EU and Japan. A blinded interim check of key secondary endpoint variability is also being added in order to verify the sample size of the study.

Serendex Pharmaceuticals obtained approval for the IMPALA study from Japanese authorities in 2016 prior to Serendex’s acquisition by Savara later that year.

Savara recently announced that it is also developing Molgradex for the treatment of nontuberculous mycobacterial (NTM) lung infections.

Read the Savara press release.