GLPG1690, an investigational therapy developed by Galapagos to treat idiopathic pulmonary fibrosis (IPF), prevented further lung decline in a Phase 2a trial, allowing the Belgian pharmaceutical firm to rapidly move forward with the clinical development of this therapy.
The trial, called FLORA (NCT02738801), involved randomly assigning 17 IPF patients treatment with GLPG1690 and six with placebo. Although the exploratory study sought to assess the drug’s safety, tolerability and properties in IPF patients, results showed that after 12 weeks, patients treated with GLPG1690 had improved their forced vital capacity (FVC) — a measure of lung function — by an average of 8 ml. Those receiving placebo saw their FVC decline by 87 ml.
“The stabilization of FVC over 12 weeks upon GLPG1690 treatment is a major milestone in IPF, where, by way of reference, the currently approved treatments show a decrease of approximately 30 mL over the same treatment period,” Piet Wigerinck, the company’s chief scientific officer, said in a press release.
A more sensitive type of functional respiratory imaging confirmed that IPF stabilized in treated patients, further demonstrating GLPG1690’s benefits.
Calling the results “extremely exciting, Toby Maher, a professor of interstitial lung disease at Imperial College London, said they exceeded those of previous studies.
“This brings hope to patients with idiopathic pulmonary fibrosis that new effective treatment may be on the horizon,” said Maher, who is also a consultant physician at London’s Royal Brompton Hospital. “Importantly, some patients even showed an increase of lung function within only 12 weeks of treatment, and the drug was well tolerated.”
GLPG1690 blocks the autotaxin enzyme, which researchers think helps cause fibrosis and disease progression in IPF. Measurements confirmed that the drug did work as intended, since the blood of treated patients showed an increase in a marker of autotaxin inhibition.
In addition, rates of patients stopping the treatment due to dverse events were similar in the two treatment groups (GLPG1690 and placebo), as were rates of serious adverse events.
Galapagos is now in talks with regulatory agencies to agree on the setup of a late-stage trial.
“The results from FLORA beg the question how patients will fare with longer treatment,” said Maher. “I urge Galapagos and the IPF community to progress to the next phase of clinical trials as rapidly as possible.”