Serendex Pharmaceuticals has announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved the company’s planned IMPALA Phase 2/3 clinical trial of Molgradex inhaled molgramostim for pulmonary alveolar proteinosis (PAP). According to the company, the trial has already been approved in Denmark and the Netherlands, and will also include sites in Israel and Russia.
Serendex CEO Kim Arvid Nielsen said, “We are well prepared to include the first patients in the IMPALA trial in Japan by the end of May 2016 or as soon as we have IRB approval. We hope the trial will demonstrate positive results that will pave the road for a marketing approval of Molgradex in Japan in 2019.”
The company recently announced positive topline results from a Phase 1 trial of Molgradex.
Read the Serendex press release.
