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Galapagos mid-stage trial failure raises concerns for Gilead deal

Investigational osteoarthritis treatment misses primary endpoint in phase 2 study

Biotech company Galapagos has reported some disappointing results for its investigational osteoarthritis drug GLPG1972, raising doubts about the prospects of its $5.1bn Gilead deal.

Galapagos and its development partner for GLPG1972 Servier announced that the drug failed to improve outcomes in the phase 2 ROCCELLA study of knee osteoarthritis patients and was also unable to hit all secondary endpoints in the trial.

The drug was tested as three different once-daily oral doses in 932 patients with knee osteoarthritis over 52 weeks of treatment, however no dose was able to produce a significant difference compared to placebo.

“While we are disappointed that ADAMTS-5 inhibition by GLPG1972 proved not to make a difference in this trial, we want to express our gratitude to all participating patients and investigators,” said Walid Abi-Saab, chief medical officer of Galapagos.

“This study result, while not what we hoped for, does add to the body of knowledge to help fight OA, a disease with substantial unmet medical need,” he added.

Last year, Gilead announced a $5.1bn deal for access to Galapagos’ late-stage pipeline, and gained rights to GLPG1972 in the process.

At that time, Gilead agreed to an option fee for GLPG1927 worth $250m if the drug proved promising in the targeted osteoarthritis indication, as well as a further $200m related to endpoints in the phase 2b study and $550m in related milestones.

Following the disappointing results, Galapagos has lost out on the funds, with more pressure piled onto the other focal drug of the Gilead alliance – filgotinib.

However, earlier this year the US Food and Drug Administration rejected Gilead’s submission for filgotinib for rheumatoid arthritis.

The regulatory authority said that it required additional data from two ongoing safety studies of the investigational drug, as well as raising concerns regarding the ‘overall benefit/risk profile of the filgotinib 200mg dose’.

Gilead can pin some of its hopes on another of Galapagos’ late-stage clinical trial assets – GLPG1690 – which is currently being studied in a phase 3 trial in idiopathic pulmonary fibrosis (IPF).

However, the failure of GLPG1972 exacerbates the issues surrounding filgotinib and puts the Galapagos deal, which is the first major development deal executed by Gilead’s new chief executive officer Daniel O’Day, even further into question.

Article by
Lucy Parsons

19th October 2020

From: Research

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