With eyes on an IPF franchise, Galapagos pushes second candidate into a dose-finding study
While the proof-of-concept results for Galapagos’ second idiopathic pulmonary fibrosis candidate didn’t turn up quite as much excitement as its lead candidate, the Belgian biotech says it’s enough to push forward with a dose-finding study.
The Phase II study assessed GLPG1205 in 68 IPF patients over 26 weeks. Volunteers were allowed to continue their standard of care, including nintedanib and pirfenidone. While the early study “was not powered to show statistical significance,” according to the company, those in the treatment arm showed a smaller forced vital capacity (FVC) decline from baseline than those on a placebo — 34 mL, compared to 76 mL in the placebo arm.
Researchers saw no “relevant safety signals” in those who took the treatment on top of pirfenidone. However, those who took it with nintedanib experienced high-grade treatment-emergent adverse events, though Galapagos didn’t specify what they were.
For those who took the drug alone, the most frequently reported side effects were gastrointestinal disorders, especially nausea.
In a proof-of-concept conducted years ago, Galapagos’ lead candidate, ziritaxestat, increased FVC by 8mL, compared to a placebo group which saw a mean decline from baseline of 87 mL. Still, with its eyes on an IPF franchise, Galapagos is lining up GLPG1205 as a potential successor to ziritaxestat.
Galapagos’ stock $GLPG was up 3.48% on Tuesday, at $126.88 a share.
“Keeping in mind the limitations of this early clinical study, the PINTA study with GLPG1205 is a positive trial,” Toby Maher, a University of Southern California Keck School of Medicine professor, said in a statement. “…While we need to understand more about long-term tolerability of the drug, the PINTA results warrant further investigation.”
GLPG1205 takes a different approach than ziritaxestat, which was a focal point in a recent $5 billion licensing deal with Gilead. Ziritaxestat inhibits autotaxin — an emerging IPF target due to its role in generating lysophosphatidic acid, which promotes inflammation and fibrosis.
GLPG1205, on the other hand, is a small molecule that antagonizes GPR84.
“This additional novel mode of action may complement the anti-fibrotic approaches within our expanding IPF portfolio,” Galapagos CSO Piet Wigerinck said in a statement.
Bridge Biotherapeutics also has an autotaxin inhibitor for IPF, which former partner Boehringer Ingelheim dropped last month over toxicity concerns. Safety worries also caused Biogen to pull the plug on its Phase II IPF program last year, which it picked up from the Stromedix buyout. FibroGen is currently in Phase III with its own IPF rival.
Next up, GLPG1205 is headed for a Phase IIb dose-finding trial. The company says it’s submitting the full Phase II results to an upcoming medical conference.