Santhera starts Phase Ib/IIa trial for patients with cystic fibrosis

Santhera Pharmaceuticals (SIX: SANN) announces the start of a Phase Ib/IIa multiple ascending dose (MAD) trial with POL6014 in patients with cystic fibrosis (CF).

POL6014 is an innovative, potent and selective inhibitor of human neutrophil elastase (hNE) in clinical development for the treatment of CF. The Phase Ib/IIa MAD study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in up to 40 patients with CF. Patients will be treated for 15 days with either placebo or one of three ascending doses of POL6014 given once or twice daily. The trial, which is taking place in sites in Germany and Poland, is expected to complete in 2H 2019.

"In chronic inflammatory conditions of the lung, neutrophils are abundantly present in the tissue and sputum," said Marcus Mall, MD, Professor and Head of Department of Pediatrics, Division of Pneumonology, Immunology and Intensive Medicine at the Charité - Universitätsmedizin Berlin. "POL6014 brings new promise to patients with CF, who, despite the introductions of various new treatment options, continue to experience lung tissue inflammation which contributes to pulmonary exacerbations. I am very excited to be part of this Phase Ib/IIa trial, which will further profile POL6014 as an innovative treatment option."

"POL6014 may be beneficial in treating various pulmonary diseases, where inflammation persists due to elevated neutrophil elastase levels and we are excited to initiate this Phase Ib/IIa trial in patients with CF," said Kristina Sjöblom Nygren, MD, Chief Medical Officer and Head of Development at Santhera. "Santhera will be working with leading experts in CF, as well as the Therapeutics Development Network (TDN) and Clinical Trial Network (CTN), throughout the development of POL6014."

Santhera obtained the worldwide, exclusive rights from Polyphor AG to develop and commercialize POL6014 in CF and other pulmonary diseases. The Cystic Fibrosis Foundation (CFF) is providing funding support for the conduct of the safety trials with POL6014.