Serendex Pharmaceuticals A/S, a company develops drugs to treat severe respiratory conditions, has signed a formal sponsor agreement with the internationally recognized Universities of Giessen and Marburg Lung Center (UGMLC) to conduct a phase II study intending to investigate the efficacy of inhaled granulocyte macrophage colony stimulating factor (GM-CSF) in patients with pneumonia-associated acute respiratory distress syndrome (ARDS).

UGMLC is one of five dedicated lung specialist centers of excellence (DZL) in Germany and its intensive care unit (ICU) is the largest pulmonology ICU in Germany.

 “As we continue to move forward with our GM-CSF pipeline, a partnership with UGMLC is a testament to the progress of our development strategy and we are proud of the partnership, which will get us closer to our goal of marketing authorization within 5 to 6 years”, explains Kim Arvid Nielsen, CEO of Serendex.

UGMLC and Serendex are set to perform the clinical Phase II study in UGMLC’s lung center in Giessen, Germany. UGMLC has prepared the protocol and will be coordinating the involvement of selected DZL lung centers in the performance of the Phase II study. The study is estimated to begin in Q3 2015 and UGMLC is set to appoint three qualified members from DZL to participate in Serendex’s GM-CSF Scientific Advisory Board.

“We have confidence in GM-CSF as a future treatment option for lung diseases such as acute respiratory distress syndrome (ARDS). It was therefore only natural for us to partner up with Serendex to explore this further together,” says Professor Jürgen Lohmeyer, head of UGMLC’s Department of Infectious Diseases and one of the leading experts in Europe within pulmonary infectious diseases.

The phase II study will provide Serendex with data for further clinical development in order to obtain regulatory approval of GM-CSF for the treatment of ARDS.

Dr Susanne Herold, a leading scientist in Professor Jürgen Lohmeyer’s team at UGMLC, has already achieved strong results from early studies with GM-CSF. “We have studied the 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. Working together with Serendex on GM-CSF will allow us to explore even further and help patients who are in need.”

Serendex Pharmaceuticals develops drugs to treat severe respiratory conditions such as PAP (pulmonary alveolar  proteinosis), BE (bronchiectasis), CF (cystic fibrosis related lung infections), acute respiratory distress syndrome (ARDS) and  DAH (diffuse alveolar hemorrhage).

The university medical school sites at Giessen and Marburg and the Max-Planck Institute for Heart and Lung Research unite scientific and clinical competencies to make the UGMLC an internationally leading center for research and treatment of pulmonary diseases.