BLOO7 schreef op 31 oktober 2018 22:27:
Galapagos reports initiation of PINTA Phase 2 trial with GLPG1205 in patients with Idiopathic Pulmonary Fibrosis (IPF)
31 October 2018 at 22:01 CET
Mechelen, Belgium; 31 October 2018; 22:01 CET - Galapagos NV (Euronext & NASDAQ: GLPG) reports first dosing in the PINTA Phase 2 trial with its GPR84 antagonist GLPG1205 in patients with idiopathic pulmonary fibrosis (IPF).
PINTA is a randomized, double-blind, placebo-controlled Phase 2 trial investigating a 100 mg once-daily oral dose of GLPG1205 in up to 60 IPF patients. The first patient was dosed in a center opened in Slovakia.
Galapagos currently has three drug candidates with distinct mechanisms of action in its fully proprietary portfolio aimed at building an IPF franchise: GLPG1690 in the ISABELA Phase 3 program, GLPG1205 in the PINTA Phase 2 trial, and GLPG3499, currently in pre-clinical development.
"The first patient dosing in our PINTA Phase 2 trial shows the progress we are making in expanding our IPF franchise," said Dr. Piet Wigerinck, Chief Scientific Officer at Galapagos. "We are strongly committed to the rapid development of our fully proprietary IPF portfolio to address this important unmet medical need."
About GLPG1205
GLPG1205, fully proprietary to Galapagos, is a small molecule selectively antagonizing GPR84. Galapagos identified the GPR84 target using its proprietary target discovery platform and developed GLPG1205 as an antagonist of this target. GLPG1205 showed promising results in relevant pre-clinical models for IPF, and there is growing evidence in scientific literature and in clinical research that GPR84 plays a role in this disease. GLPG1205 successfully completed several Phase 1 trials, showing favorable findings relating to tolerability, and target engagement in healthy volunteers. GLPG1205 showed good tolerability but no activity in ulcerative colitis patients in 2016. GLPG1205 is an investigational drug and its efficacy and safety have not yet been established.
For information about the studies with GLPG1205:
www.clinicaltrials.gov (NCT03725852)
For more information about GLPG1205:
www.glpg.com/ipfAbout IPF
IPF is a chronic, relentlessly progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. There are approximately 200,000 patients with IPF in the U.S. and Europe. As such, IPF is considered a rare disease. The clinical prognosis of patients with IPF is poor as the median survival at diagnosis is 2 to 4 years. Currently, no medical therapies have been found to cure IPF. The medical treatment strategy aims to slow the disease progression and improve the quality of life.
About the PINTA trial
PINTA is a randomized, double-blind, placebo-controlled Phase 2 trial investigating a 100 mg once-daily oral dose of GLPG1205. The drug candidate or placebo will be administered for 26 weeks in up to 60 IPF patients. Patients may remain on their local standard of care as background therapy, whether or not they were previously or currently are treated with Esbriet®[1] (pirfenidone) and Ofev®[2] (nintedanib). The primary objective of the trial is to assess the change from baseline in Forced Vital Capacity (FVC in mL) over 26 weeks compared to placebo. Secondary measures include safety, tolerability, pharmacokinetics and pharmacodynamics, time to major events, changes in functional exercise capacity, and quality of life. Recruitment for PINTA is planned in 10 countries in Europe, North Africa, and the Middle East.