Well-funded orphan lung disease company with four clinical studies in late-stage pipeline. The two Phase 3 studies include 1) IMPALA: Molgradex (inhaled GM-CSF) for autoimmune pulmonary alveolar proteinosis (aPAP), and 2) AVAIL: AeroVanc (inhaled vancomycin) for MRSA lung infection in CF. The two studies in Phase 2 development are both investigating Molgradex for the treatment of NTM lung infection. OPTIMA is in non-CF patients and ENCORE is in CF patients. In June 2019, topline results from IMPALA were announced. While the study did not achieve statistical significance on the primary endpoint, the totality of the efficacy data are encouraging and adverse event frequencies were similar between the treatment arms and placebo. The company was granted a Type C meeting with the FDA and recently received a written response from the agency indicating the briefing package did not provide sufficient evidence of efficacy and safety. The company is evaluating the feedback from the FDA to determine the best path forward, which may include another Phase 3 trial. Savara still anticipates filing for Breakthrough Designation in the US.
Fibrosis, Rare Disease, Respiratory
Biotechnology, Life Sciences
6836 Bee Cave Road
Building 3, Suite 200
Austin, TX 78746
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