Drug Development

Galapagos, AbbVie glimpse early progress in search of a cystic fibrosis triple to rival Vertex

Piet Wigerinck, Galapagos. Credit: Felix Kalkman

Piet Wigerinck, Galapagos. Credit: Felix Kalkman

AbbVie $ABBV and its partner Galapagos $GLPG are pleased with some of the early data they’re seeing for one piece of their triple drug puzzle for cystic fibrosis. And they’re planning to give Vertex a run for its money on this front.

In a small study involving 26 patients with the G551D mutation in CFTR, a dose-escalating regimen of the CFTR potentiator GLPG1837 produced a statistically significant drop in sweat chloride concentration.

That is an early snapshot they need to continue to blaze a trail for a new cystic fibrosis cocktail therapy, taking on market leader Vertex and its pioneering drug Kalydeco as it lines up a triple standard of its own.

Just a month ago the two partners launched a Phase I study of their novel C2 corrector GLPG2737, the first of many C2 correctors being developed and “the final component needed to complete a first triple combination.” Potentiators GLPG1837 and GLPG2451 and C1 corrector GLPG2222 are all in the clinic as they sort out the best candidates for a cocktail.

Setting up a rivalry with Vertex, though, is problematic at best. Barclays noted:

Overall, we see these data as interesting, yet highlight the early nature of the program and believe the development timeline of a Galapagos triple combination is aggressive with clinical trials slated to begin 3Q17e. Even if Galapagos is able to maintain timelines, Vertex is rapidly progressing with next-gen correctors VX-661 in combination with Kalydeco and VX-440 and VX-152 as part of a triple combination, which could become new standards. While today’s data represent a step forward for Galapagos and development partner AbbVie, it remains considerably early to evaluate the potential of ‘1837 as a competitor to Vertex.

AbbVie and Galapagos, though, seem determined to give it a try.

“The success of this trial is an important milestone in two regards; firstly, GLPG1837 has shown safety and significant efficacy as a novel CFTR potentiator. Secondly, it demonstrates that the CF community is committed to the further development of CFTR modulators despite the complexities related to evolving standards of care,” commented Jane Davies of the Royal Brompton & Harefield NHS Trust in London and principal investigator for SAPHIRA 1.

“The SAPHIRA 1 results show this is the first new potentiator since Kalydeco to demonstrate competitive results in patients harboring the G551D mutation. Galapagos has a suite of potentiators in development. Galapagos and AbbVie will further study the data before deciding which potentiator will be included in the triple combination,” said Dr Piet Wigerinck, CSO of Galapagos. “The clinical validation of our in vitro systems reinforces our belief in our approach to get to a triple combination therapy.”

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