Shares of Galapagos NV fell more than 15 percent Thursday afternoon and continued to fall in premarket trading after the Belgium-based company said AbbVie opted to walk away from its cystic fibrosis collaboration.
Shares of Galapagos NV fell more than 15 percent Thursday afternoon and continued to fall in premarket trading after the Belgium-based company said AbbVie opted to walk away from its cystic fibrosis collaboration.
On Thursday Galapagos announced mixed topline results from its investigational C2 corrector GLPG2737 in adult cystic fibrosis patients who are homozygous for the Class II F508del mutation. The company said its Phase II trial had been on stable treatment with Vertex Pharmaceuticals’ CF treatment Orkambi for at least 12 weeks prior to administration of the experimental treatment. Piet Wigerinck, chief scientific officer of Galapagos, said the Phase II PELICAN trial is the first to evaluate GLPG2737 as a C2 corrector in CF patients on top of Orkambi. The trial showed “CFTR on-target activity” with the combination treatment.
Patients were administered the Galapagos treatment alongside Orkambi to judge the change from baseline in sweat chloride concentration. Galapagos said the mean change from baseline in sweat chloride for the GLPG2737 treatment arm on day 28 versus placebo was a “significant decrease of 19.6 mmol/L.” Additionally, the company said a positive trend in ppFEV1 changes was observed. Galapagos reported that the mean absolute change from baseline in ppFEV1 for the GLPG2737 treatment arm through day 28 was 3.4 percent – which was below the 5 percent mark some analysts were hoping to see.
GLPG2737 was well-tolerated by patients in this trial. All adverse events were mild to moderate, with no apparent difference compared to placebo. Galapagos said it will present further details from the trial at a future conference.
Despite the positive outlook from Galapagos, analysts were not too wowed by the news. RBC Capital analyst Brian Abrahams noted that the company’s results indicate it will unlikely be able to compete with Vertex, the leader in the cystic fibrosis treatment space. While Galapagos’ stock has plunged, shares of Vertex have soared. In premarket trading shares of Vertex are up more than 8 percent to $160.
Not only did the Galapagos trial fail to meet the expectation of some analysts, the company also noted that AbbVie walked away from its development deal for triple combination CF treatments. In its announcement Thursday, Galapagos said Illinois-based AbbVie decided to “not to proceed with the previously contemplated second triple combination therapy, consisting of the same C1 and C2 components combined with potentiator GLPG3067.” Galapagos said it is reviewing the future of its CF collaboration with AbbVie.
This is the second time that AbbVie and Galapagos have parted ways on a collaborative agreement. In 2015 AbbVie walked away from a $1.4 billion for its selective JAK1 inhibitor, filgotinib. Fligotinib was being developed for the treatment of rheumatoid arthritis.
Although AbbVie is not continuing with the CF collaboration, Galapagos said it will move forward.
“We have initiated dosing in the FALCON trial, in which we aim to evaluate higher exposures of GLPG2737 in CF patients and further understand the potential synergistic effect of GLPG2737 on top of our own dual combination compounds,” Wigerinck said in a statement.
The FALCON trial is studying the combination of GLPG2451, C1 corrector GLPG2222, and C2 corrector GLPG2737. The company anticipates interim data in the third quarter of 2018.
