Galapagos ($GLPG), on the rebound after losing some key partnerships, reported positive Phase II results for its lead drug in Crohn's disease, paving a path to late-stage development.
The Belgian company said filgotinib, an oral treatment, met its primary endpoint of significantly besting placebo at reducing symptoms of Crohn's, an inflammatory bowel disease.
Galapagos measured efficacy with the Crohn's Disease Activity Index, or CDAI. Filgotinib beat placebo at getting patients below 150 points on the CDAI scale, which Galapagos said is evidence of clinical remission, but did not make a significant difference in CDAI reductions of 100 points or more. The drug met its third goal of improving responses on a quality-of-life questionnaire, the company said.
The results, which sent Galapagos' shares up about 15%, merit moving filgotinib into a Phase III Crohn's program "as soon as possible," CEO Onno van de Stolpe said in a statement.
The drug, which blocks the inflammation-related enzyme JAK1, is slated to enter Phase III in rheumatoid arthritis early next year, and Galapagos is searching for a deep-pocketed partner to pay its way.
In September, AbbVie ($ABBV) backed out of a partnership worth up to $1.4 billion to focus on an in-house JAK1 inhibitor, leaving Galapagos to fend for itself on the eve of Phase III. The company has since embarked on a roadshow with filgotinib, and van de Stolpe has said the company hopes to nail down a new alliance by year's end.
Galapagos pulled off a $275 million U.S. IPO earlier this year on the promise of filgotinib and an inflammation-focused pipeline many thought would tee the company up for a Big Pharma buyout. But AbbVie's departure--preceded by similar breakups with Johnson & Johnson ($JNJ) and GlaxoSmithKline ($GSK)--has dimmed Wall Street expectations for Galapagos.
- read the statement (PDF)