Thinly traded micro cap Savara (NASDAQ:SVRA) is poised for a significant down move after announcing that its Phase 3 clinical trial, IMPALA, evaluating lead drug Molgradex in patients with autoimmune alveolar pulmonary proteinosis (aPAP) failed to sufficiently separate from placebo.
The study did not achieve the primary endpoint of a statistically significant change from baseline to week 24 in a measure of low blood oxygen called alveolar-arterial oxygen gradient (A-aDO2). Specifically, average A-aDO2improved 12.1 mmHg in the treatment group compared to 8.8 mmHg in the placebo arm (p=0.17), falling short of statistical significance.
There was a statistically valid separation from control for a secondary endpoint of a patient-reported outcomes/quality of life scale called SGRQ. Another secondary endpoint, the six-minute walk test, failed to adequately separate from control.
On a positive note, the safety profile was on par with placebo.
APAP is a rare autoimmune disorder in which a surfactant accumulates in the alveoli (tiny air sacs in the lungs) making it difficult to breathe.
The company plans to meet with the FDA and EMA in the coming months to discuss the data and a path forward.
Management will host a conference call today at 5:30 pm ET to discuss the results.
Shares will resume trading at 4:30 pm ET.
Update: Shares are down 75% after hours.
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