Molgradex, the company’s drug for Autoimmune Alveolar Pulmonary Proteinosis, was tested against a placebo and measured for improvement in the alveolar-arterial oxygen gradient, the ratio of oxygen concentration in the lungs and arteries.
Shares collapsed on the disappointing results, falling 75% to $2.59.
Patients given the treatment saw an improvement not statistically significant from the placebo.
That said, patient-reported outcomes and quality of life measurements did improve with treatment, which was considered a secondary endpoint of the study, known as IMPALA.
"Disappointingly, with the placebo effect stronger than anticipated, the study did not meet its primary endpoint,” CEO Rob Neville said. “We are preparing to meet with the FDA and [the European Medicines Agency] to discuss the results from this study and to determine our options to seek approval based on the current data, and potentially conduct an additional study incorporating the learnings from IMPALA."
Savara is an Austin, Texas orphan lung disease pharmaceutical company.
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel