Galapagos announces design for PINTA Phase 2 trial with GLPG1205 in IPF

Galapagos announces the PINTA Phase 2 trial design with its GPR84 inhibitor GLPG1205 in patients with idiopathic pulmonary fibrosis (IPF). PINTA is a randomized, double-blind, placebo-controlled 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. 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. IPF diagnosis will be confirmed by central reading. Recruitment for PINTA is planned in 10 countries in Europe, North Africa, and the Middle East. First dosing of an IPF patient is expected in the second half of 2018.

GLPG1205 is a GPR84 inhibitor discovered by Galapagos and fully proprietary to Galapagos. GLPG1205 showed a reduction in signs and symptoms in IPF animal models and has shown favorable tolerability in healthy volunteers and ulcerative colitis patients in previous trials. 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 PINTA Phase 2, and GLPG3499, currently in pre-clinical development.

“GLPG1205 has shown signs of good activity in relevant animal models, and GPR84 has already been validated as a mechanism in combination with nintedanib[1] in IPF,” added Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos. “We have a well-designed trial with PINTA for ‘1205 that we anticipate will give us new insights into the potential value of GPR84 inhibition as a mechanism to treat this highly fatal disease.”

Source: Galapagos