Galapagos to take IPF drug into late-stage trial after phase 2 win

Belgian biotech Galapagos has chalked up a positive phase 2a trial for its idiopathic pulmonary fibrosis (IPF) drug GLPG1690, saying it halted the relentless decline in lung function normally seen in patients.

Armed with the new proof-of-concept data, Galapagos says it will now push on with late-stage testing of the autotaxin inhibitor—which it says is the first drug in the class to show an effect on IPF in a clinical trial.

Lung function, measured by forced vital capacity (FVC), stabilized in patients on GLPG1690 over the course of the 12-week FLORA study, while those on placebo showed the "expected decline," said the biotech. Over the 12-week period, patients receiving GLPG1690 showed an FVC increase of 8 mL from baseline, while patients on placebo showed an FVC reduction of 87 mL.

Added to that, treatment with the drug candidate improved biomarkers including LPA18:2, a measure of autotaxin inhibition, and the drug was well-tolerated with dropout rates roughly the same between the treatment and placebo groups.

Investors reacted with enthusiasm, driving shares of the biotech up around 22% in the wake of the announcement. The gains didn't however match the 60% hike in FibroGen's stock after it reported strong midstage data for anti-connective tissue growth factor antibody pamrevlumab earlier this week, which came from a longer, 48-week study.

Imperial College and Royal Brompton Hospital professor Toby Maher said in the announcement that the data were "extremely exciting," particularly as some patients showed an increase in lung function "within only 12 weeks of treatment."

"The results from FLORA beg the question how patients will fare with longer treatment. I urge Galapagos and the IPF community to progress to the next phase of clinical trials as rapidly as possible," he added.

The successful trial is an important boost for Galapagos after it delayed its AbbVie-partnered cystic fibrosis program earlier this year, just before rival Vertex Pharmaceuticals aced midstage trials with its candidates, setting up a phase 3 program early next year and giving it a healthy lead in the race to market.

Galapagos Chief Scientific Officer Piet Wigerinck said in the announcement that the new data "marks an important milestone for Galapagos as a company: proof of concept in patients of a second mechanism of action coming from our target discovery platform."

If they reach the market, Galapagos and FibroGen's candidates will enter a fast-growing market currently being hotly contested by Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), which posted sales of around $500 million and $430 million respectively in the first half of the year.

Analysts at Morgan Stanley said the data—albeit from a small study—are "compelling" and comparisons with earlier data for Ofev and Esbriet suggest Galapagos' drug could be "highly active in IPF."