Galapagos Starts SAPHIRA Phase II Study With GLPG1837 in Cystic Fibrosis Patients


Galapagos NV recently announced the first dosing in its Phase II exploratory program of GLPG1837 in patients with cystic fibrosis (CF). GLPG1837 is a candidate CFTR potentiator drug in clinical development for the treatment of Class III mutations in cystic fibrosis. The SAPHIRA Phase II program will explore the safety, tolerability, and efficacy properties of GLP1837 in CF patients with a G551D (SAPHIRA 1) or S1251N (SAPHIRA 2) Class III mutation. Topline results from the SAPHIRA Phase II program are expected in Q4 2016.

“Today’s announcement is a landmark achievement in our CF program, with the first CF patient being treated with a Galapagos potentiator,” said Onno van de Stolpe, CEO of Galapagos. “Recruitment for the SAPHIRA program is rapid, and we look forward to seeing to what extent our promising in vitro data translates into clinical results. We aim to start and report a number of clinical studies with additional compounds in the CF portfolio throughout 2016.”

SAPHIRA 2, an open-label study of two doses of GLPG1837 in at least six CF patients with the S1251N mutation, was first dosed in a patient last week. SAPHIRA 1, an open-label study of three doses of GLPG1837 in at least 12 patients with the G551D mutation, is expected to begin dosing soon. The SAPHIRA Phase II program will explore the safety, tolerability, efficacy, and medicine-like properties of GLPG1837 in patients in six EU countries and Australia. Primary objectives are to evaluate the safety and tolerability; secondary objectives are to assess changes in sweat chloride from baseline as the biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function and to explore the changes in pulmonary function (forced expiratory volume in 1 second [FEV1]) from baseline. Both studies will include subjects treated with Kalydeco as well as those who are naïve to this drug. In each study, different doses of GLPG1837 tablets will be administered twice daily for a total duration of 4 weeks.

In September 2013, Galapagos and AbbVie, a global biopharmaceutical company, entered into a global collaboration agreement focused on the discovery and worldwide development and commercialization of potentiator and corrector molecules in a potential triple combination therapy for the treatment of CF. Under the terms of the agreement, AbbVie made an upfront payment of $45 million to Galapagos. Upon successful completion by Galapagos of clinical development through to completion of Phase II, AbbVie will be responsible for Phase III, with financial contribution by Galapagos. Galapagos has earned $20 million in milestone payments to date and is eligible to receive up to $340 million in total additional payments for developmental and regulatory milestones, sales milestones upon the achievement of minimum annual net sales thresholds, and additional tiered royalty payments on net sales, ranging from mid-teens to 20%.

Galapagos is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Its pipeline comprises three Phase II, two Phase I, four preclinical, and 20 discovery studies in cystic fibrosis, inflammation, fibrosis, osteoarthritis, and other indications. It has discovered and developed filgotinib: in collaboration with Gilead they aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world.

Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium, headquarters and facilities in The Netherlands, France, and Croatia. For more information, visit www.glpg.com.