- Belgian biotech Galapagos won’t pursue an expanded approval of its only marketed drug after the medicine failed to achieve the initial goals of a late-stage study in Crohn’s disease.
- Researchers tested the drug, filgotinib, in 1,374 patients with the inflammatory bowel disease, splitting them among those who had previously received treatment with a biologic and those who hadn’t. The primary endpoints were clinical remission reported by patients and disease response measured with the use of an endoscope.
- Patients who received filgotinib failed to meet either endpoint in the initial 10-week phase of the trial, although Galapagos reported a significantly greater response rate after 58 weeks among those on a high dose compared to participants on placebo. Still, the company said Wednesday the data aren’t strong enough to seek European approval of filgotinib in Crohn’s disease.
The study is the latest setback for a once high-flying biotech. The company’s American depositary receipts, which topped $274 a piece in early 2020, dropped 8% to about $40 in early trading Thursday.
Filgotinib was at the center of a partnership with Gilead originally inked in 2015 and expanded with a $5.1 billion development deal announced in 2019. The companies’ first target was rheumatoid arthritis, and they appeared to have a potential blockbuster on their hands until the Food and Drug Administration issued a surprise rejection of the medicine in August 2020.
Regulators in the European Union and Japan later approved the drug, which is sold under the brand name Jyseleca. But after meeting with FDA officials, Gilead decided there was no path forward in the U.S. market and significantly scaled back its commitment to the medicine.
Other struggles followed. In February 2021, Gilead and Galapagos pulled the plug on an experimental drug for lung disease after an independent monitoring board flagged risk-benefit issues emerging from research of the medicine. Five months later, Galapagos unveiled disappointing initial results from three studies of a key experimental anti-inflammatory medicine.
The research setbacks led to a shakeup of the business. Paul Stoffels, the former chief scientific officer of Johnson & Johnson, took over as CEO in April 2022. In November, the company laid off 200 employees as it pursued a “new strategic direction.” In December, the chief medical officer and chief business officer retired.
Since becoming CEO, Stoffels has moved the company into cell therapy. Given the latest trial disappointment, success for the company’s revamped portfolio in CAR-T and immunology would be the “key value driver” going forward, RBC Capital Markets analyst Brian Abrahams said in a note to clients.
“Clearer long-term vision and credible leadership could help right the ship over time, coupled with a strong balance sheet,” Abrahams wrote.
Galapagos said it’s still “fully committed” to filgotinib and plans to start a Phase 3 study of the drug in patients with axial spondyloarthritis later this year. In November, the company said it expected net sales of the drug to reach 80-90 million euros, or $86-$97 million, in 2022.