Crohn’s is currently an unmet medical need
According to CDC, there are approximately 400-600k patients in the US that are diagnosed with Crohn’s, a debilitating, inflammatory condition of the GI tract which gives rise to symptoms such as pain, diarrhoea, fatigue, bleeding and in many cases leads to resection of the damaged part of the intestine. Given that there is no known cure, current treatments involve steroids aimed at reducing inflammation and immuno-suppressants to maintain remission. In severe cases, anti-TNFs (Humira, Remicade, Cimzia) can provide a more powerful suppression of the immune system, but many patients do not respond or relapse after treatment.
(Onno: Filgo beter dan Humira)
Oral filgotinib could provide efficacy and increased convenience
The FITZROY phase 2 study of filgotinib in Crohn’s (first reported in Dec 2015) met the primary endpoint of showing significantly higher clinical remission v placebo with a tolerable safety profile similar to that shown in previous studies. The study was also unique in that it showed improvement in endoscopic observation of ulceration and mucosal healing from baseline, which backed up the clinical remission as measured by the disease activity index (CDAI). Incidence of raised haemoglobin and reduced neutrophils, a common side effect of activity at JAK2 and JAK3, was not of concern and the lipid profile (stronger increase of HDL v LDL) was favourable.