According to Serendex Pharmaceuticals, German regulators have cleared the way for the company to initiate a phase 2 clinical trial of inhaled molgramostim (Molgradex) for the treatment of pneumonia-associated acute respiratory distress syndrome (ARDS). Earlier this year, the company announced that it had partnered with the Universities of Giessen and Marburg Lung Center (UGMLC) for the Phase 2 study for the treatment of ARDS.
Serendex CEO Kim Arvid Nielsen said, “This approval of our first Phase 2 study is yet another major milestone for Serendex. We are proud to be able to initiate the study on time and according to schedule. It also emphasizes the fact that Serendex is now a clinical company.”
The randomized, double-blind, placebo-controlled trial is expected to begin in the 4th quarter of 2015 and enroll 45 patients. Based on preliminary results UGMLC Professor Susanne Herold said, “There is evidence of a beneficial effect of GM-CSF in a small group of patients with ARDS, and not only have we seen profound effect in oxygenation but also cell markers of improved immunity in the lung.”
Serendex also said that it plans to submit an application for a Phase 2/3 clinical trial of Molgradex for the treatment of pulmonary alveolar proteinosis (PAP) in Europe by the end of the year.
Read the Serendex press release.
