Galapagos moves AbbVie-partnered drug into PhI as multipronged attack on CF takes shape

Galapagos ($GLPG) has kicked off a Phase I trial of its AbbVie ($ABBV)-partnered cystic fibrosis (CF) drug, GLPG2222. The start of the trial marks another milestone in the rolling advance of Galapagos' multipronged attack on CF, which is set to be bolstered later this year by the emergence of more next-generation correctors.

Galapagos CEO Onno van de Stolpe

Mechelen, Belgium-based Galapagos is testing the safety of GLPG2222 in a placebo-controlled Phase I trial, top-line data from which are due in the second quarter. The start of the trial triggered a $10 million (€9 million) milestone payment from AbbVie and moved Galapagos a step closer to its goal of creating a triple-combination therapy capable of simultaneously addressing the defects in cellular processing and chloride channel function that characterize CF. GLPG2222 is one of two corrector components of the planned combination.

The second corrector, GLPG2665, is now due to enter the clinic by the end of 2016, a slight slip in the timeline released in October. At that time, Galapagos had pencilled in the start of the study for the middle of the year. The two correctors are advancing in parallel to the potentiator GLPG1837, a drug intended to boost cell surface chloride transport of CFTR. A Phase II trial of GLPG1837 is getting up and running now. Beyond these drugs, Galapagos is working on a clutch of first and next-generation correctors, the most promising of which it expects to advance into the clinic later this year.

This week, Galapagos identified the first-generation corrector GLPG2851 as the next product to come down the pipeline. A Phase I trial is due to start by the end of the year. And, with Galapagos and AbbVie continuing to work on next-generation correctors, the Belgian company thinks it could move a total of four more CF drugs into the clinic before 2016 is over. "The CF franchise has really expanded into a full-sized portfolio," Galapagos CEO Onno van de Stolpe said in a statement. Galapagos is developing the portfolio to steal market share from Vertex ($VRTX).

If the portfolio can live up to this expectation, Galapagos is in line to pocket up to $340 million in milestones, plus tiered royalties that top out at 20%. The revenue stream is one of two sources of income that could ramp up at Galapagos in the coming years. Filgotinib, the JAK1 inhibitor that AbbVie turned its back on last year, is the other. The deal with Gilead ($GILD) that Galapagos struck to replace the AbbVie alliance was completed this week.

- read the release (PDF)
- and the Gilead news (PDF)

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