First patient dosed in Savara’s pivotal trial for PAP
Savara’s phase II/III clinical trial of lead drug candidate Molgradex® for patients with pulmonary alveolar proteinosis (PAP) has included its first patient.
The patient has been dosed with Savara’s proprietary, nebulized formulation of recombinant human GM-CSF Molgradex®, or placebo and is the first out of up to 51 patients to be recruited to the trial during a period of estimated one year. Top line data from the treatment period is expected 1H 2018.
Primary aim of the trial which has been named IMPALA is to confirm the efficacy and safety of Molgradex® in PAP patients. IMPALA is a randomized, double-blind, placebo-controlled multicenter trial lead by Coordinating Principal Investigator Dr. Cliff Morgan from the Royal Brompton Hospital in London, United Kingdom.
A total of 15 sites in Europe (including Russia and Israel) and Japan have been selected for the IMPALA trial.
Savara is currently also developing Molgradex® for the treatment of acute respiratory distress syndrome in a phase IIb clinical trial in Germany.
Download press release 240516 First patient dosed in Savara pivotal trial for PAP.