Serendex Pharmaceuticals has announced that data from a Phase 1 randomized, double blind, placebo controlled single ascending dose/multiple ascending dose trial showed that Molgradex inhaled GM-CSF (molgramostim) was well tolerated at all dose levels. No serious or severe events were reported, and similar numbers of subjects in both the active and control groups reported adverse events, with mild cough being the most commonly reported adverse event.
According to the company, the concentration of Molgradex in the bloodstream post-inhalation was 50-100 times less than for GM-CSF administered systemically. Of the 30 subjects in the Molgradex group, 2 had rises in white blood cell count reported as mild adverse events, and the remainder had increases in white blood cell count deemed not clinically significant.
The company said that it plans to submit an application for a European Phase 2/3 clinical trial of Molgradex for the treatment of pulmonary alveolar proteinosis (PAP) in October 2015. Serendex had previously announced that it was ready to begin a Phase 2 trial of Molgradex for the treatment of pneumonia-associated acute respiratory distress syndrome (ARDS).
Serendex CEO Kim Arvid Nielsen commented, “We are excited about the robust results from the study of Molgradex in healthy volunteers. The data demonstrates that, as designed, the new suspension formulation for nebulization is well tolerated. We will now fully analyse the data and confirm our further development plans for Molgradex with the appropriate regulatory authorities. The Phase 1 study data constitute an important milestone for the company in that it allows us to remain on track for the clinical development of Molgradex.”
Read the Serendex press release.
