Savara Inc (NASDAQ:SVRA) has obtained expert guidance from the FDA on the clinical program requirements for a NDA filing for Molgradex, targeting autoimmune PAP. Depending on the received recommendations, the firm intend to modify the statistical analyses and endpoint order of its underway IMPALA study, for now enrolling subjects in Japan and Europe, to qualify the study as a key Phase 3 trial in the U.S.
The total count of subjects to be registered will increase to 90 from 51 so as to support the changed program. If successful, this trial would serve as the major trial for regulatory filing aiming marketing authorization of Molgradex in the U.S. in addition to Japan and Europe.
Rob Neville, who is the CEO of Savara, posted that since they acquired Molgradex last year, they have posted notable progress, and having a prospect to utilize existing IMPALA trial as a worldwide Phase 3 trial is a win for the firm. It gives an opportunity to expedite the approval of the offering by removing the need to carry out a separate Phase 3 trial.
This is promising update for the PAP community in the U.S., as they contemplate Molgradex can provide a game changing therapy targeting a disease where the standard treatment is to periodically carry out an invasive lung lavage course requiring general anesthesia.
Savara announced that the IMPALA trial is planned to evaluate the safety and efficiency of Molgradex with placebo in subjects with PAP. The trial started enrolling subjects in Japan and Europe last year, and aims to extend this enrollment so as to register 90 subjects by Q1 2018. So far, 50% of planned enrollment is completed. The company expects to announce top line report by Q4 2018.
In the last trading session, the stock price of gained almost 1% to close the session at $5.35.