Galapagos allows itself a small sigh of relief
After an annus horribilis Galapagos has something positive to say about filgotinib at last. The first interim data from the Manta and Manta-Ray studies have ruled out the risk of testicular toxicity – for the time being. The trials are important because they seek to address a key reason why the US FDA threw out filgotinib’s rheumatoid arthritis filing last August. Only 6.7% of filgotinib patients in the two studies had a ≥50% decline in sperm concentration, numerically lower than the 8.3% in placebo recipients, Galapagos said today. So far so good, but these are small trials, and patients with ≥50% declines number just 18 in total; the interim data are at 13 weeks, and much longer-term results are needed to satisfy the agency. Monitoring of subjects who continue on filgotinib is set to continue for a year. Filgotinib is approved as Jyseleca in the EU, but after the US setback Galapagos’s partner, Gilead, handed back rights to rheumatoid diseases. Gilead is apparently pushing on in inflammatory bowel conditions, though these are not among its focus areas. Are the latest crumbs of comfort enough for Gilead not to pull the plug entirely? For Galapagos this is now the $64,000 question.