Savara amends Phase III IMPALA trial of Molgradex

Following guidance from FDA, Savara Inc. (NASDAQ:SVRA) amended the ongoing Phase II/III IMPALA trial evaluating Molgradex to treat autoimmune pulmonary alveolar proteinosis (PAP). Specifically, Savara increased enrollment from 51 to 90 patients. Additionally, the company said FDA will focus on 3 secondary endpoints: 6-minute walk distance (6MWD), St. George’s Respiratory Questionnaire (SGRQ) and time to need of whole lung lavage. The company said the amended trial could serve as the sole pivotal study for regulatory submission in the U.S., Europe and Japan.

The double-blind, international trial is evaluating the primary endpoint of absolute change from baseline in arterial-alveolar oxygen gradient. Additional secondary endpoints include pulmonary function tests, dyspnea score, cough score, quality of life (QOL) and safety. Patients will receive once-daily 300 µg inhaled Molgradex, once-daily 300 µg inhaled Molgradex and placebo in 7-day intermittent cycles or placebo alone for 24 weeks...