Galapagos has released the PINTA Phase ll trial design that aims to investigate GLPG1205 to treat patients with idiopathic pulmonary fibrosis (IPF).
Up to 60 IPF patients are expected to be enrolled in the randomised, double-blind, placebo-controlled trial.
As part of the trial, a 100mg once-daily oral dose of GLPG1205 or placebo will be provided to the subjects for a period of 26 weeks.
Patients can choose to remain on their local standard of care as background therapy.
PINTA’s primary objective is to evaluate the change from baseline in forced vital capacity (FVC) over 26 weeks compared to placebo.
Its secondary measures comprise safety, tolerability, pharmacokinetics and pharmacodynamics, time to major events, changes in functional exercise capacity, and quality of life.
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The trial intends to measure IPF diagnosis by central reading.
In addition, it plans to enrol patients across ten countries in Europe, North Africa, and the Middle East, and expects to dose the first patient by the second half of this year.
Galapagos chief scientific officer Dr Piet Wigerinck said: “GLPG1205 has shown signs of good activity in relevant animal models, and GPR84 has already been validated as a mechanism in combination with nintedanib in IPF.
“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.”
IPF is a chronic, persistently progressive fibrotic disorder of the lungs that usually affects adults over the age of 40.
Around 200,000 people are currently estimated to be diagnosed with IPF in the US and Europe.