New safety readouts boost Jyseleca's prospects in the US, says analyst

Belgian biotech Galapagos (Euronext: GLPG) last week announced positive pooled interim results from its ongoing MANTA and MANTA-RAy safety studies for Jyseleca (filgotinib).

Commenting on the results, data and analytics firm GlobalData’s analyst Rose Joachim said that the interim data from MANTA and MANTA-RAy should ease fears that Jyseleca may negatively impact sperm health in men with inflammatory bowel disease (IBD) or rheumatic diseases. Although the trials were not powered for comparison across groups, fewer patients treated with Jyseleca (200mg) versus placebo experienced a 50% or greater decline in sperm concentration over the initial 13-week double-blind treatment period. These data renew hope for Jyseleca in the US IBD space.

“Although pending outcomes from these trials factored into Jyseleca’s complete response letter in rheumatoid arthritis (RA), sperm toxicity data will arguably be of greater importance when considering the drug’s applications in ulcerative colitis (UC) and Crohn’s disease (CD), as these diseases are more likely to affect younger men. According to GlobalData’s epidemiological analysis, in 2021, men between the ages of 20 and 65 will comprise around 35% of the total diagnosed prevalent cases of CD and UC (among patients 20 years of age or older). In contrast, this group of patients accounts for only 13% of cases in RA,” she said.