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Galapagos (GLPG.BR)' Phase II Results With GLPG1690 are 'Extremely Exciting'



8/10/2017 6:32:46 AM

Galapagos' Phase II Results with GLPG1690 are 'Extremely Exciting' August 10, 2017
By Alex Keown, BioSpace.com Breaking News Staff

MECHELEN, Belgium – Shares of Galapagos NV (GLPG) are up more than 10 percent this morning after the company announced positive results from its Phase IIa idiopathic pulmonary fibrosis trial.


During the FLORA trial 17 of 23 IPF patients received GLPG1690. The other six received a placebo. Primary objectives of the trial were to assess safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG1690 in an IPF patient population. Secondary objectives included the evaluation of lung function, changes in disease biomarkers, FRI, and quality of life. The company said its autotaxin inhibitor GLPG1690 met endpoints in increasing forced vital capacity (FVC) of lungs in the small number of patients who were administered the treatment. Data shows that a 12-week treatment with GLPG1690 showed an FVC increase of 8 mL, while patients on placebo showed an FVC reduction of 87 mL (mean from baseline).

Additionally, Galapagos said patients on GLPG1690 showed a “clear reduction of serum LPA18:2,” which is a biomarker for autotaxin inhibition. The company said this was expected based on the mechanism of action of GLPG1690.

Piet Wigerinck, chief scientific officer of Galapagos, said the trial shows that GLPG1690 has promise as a potential therapy for IPF. He said the Phase IIa results also mark an important milestone for the company. He said the therapeutic platform continues to novel mechanisms of action beyond JAK1 in inflammation.

“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," Wigerinck said in a statement.

Toby Maher, Professor of Interstitial Lung Disease at Imperial College, London and Consultant Physician at Royal Brompton Hospital, London also hailed the results.
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"Galapagos' results with GLPG1690 are extremely exciting and exceed those of previous studies. This brings hope to patients with idiopathic pulmonary fibrosis that new effective treatment may be on the horizon. Importantly, some patients even showed an increase of lung function within only 12 weeks of treatment, and the drug was well tolerated. 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," Maher said in a statement.

Earlier this week, Bay Area’s FibroGen Inc. (FGEN) released its own stellar results for IPF treatment. That company said its Phase II trial met endpoints in targeting anti-connective tissue growth factor (CTGF). Shares of FibroGen rocketed up on Tuesday after the company released its report, hitting a high of $51.22 per share. Shares have fallen since then and this morning are trading at $41.92.

Galapagos plans to rapidly progress GLPG1690 in a late stage trial and had already discussions with regulators regarding trial design. Galapagos also plans to report the FLORA study results at a future medical conference.

Shares of Galapagos had a morning high of $83.94 as of 9:34 a.m.


Read at BioSpace.com


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