The European Commission has approved Alofisel, previously known as Cx601, a stem cell therapy that treats complex perianal fistulas, one of the most restricting complications of Crohn’s disease. Alofisel was developed by Belgian biotech company TiGenix, and is licensed to the Japanese pharma Takeda. It is the first stem cell therapy created through donor stem cells to receive marketing authorization in Europe, and is currently seeking approval in the US, expecting results in 2020.
Stem cell therapy provides an alternative option for patients that have already undergone multiple unsuccessful biologic therapy surgeries. For sufferers of Crohn’s disease, this could be a welcomed new treatment. Crohn’s disease is a chronic inflammatory disease of the digestive system, and can cause painful symptoms such as diarrhea, abdominal pain, blood in feces, weight loss, and fatigue. In the EU alone, 1.1 million people are estimated to be affected. As of now, it is a life-long disease with no cure.
Alofisel uses stem cells from donors through a liposuction, and a study has been conducted in over 200 patients to study whether the stem cell therapy was able to close all fistulas and leave no remaining infection sites visible to an MRI. In the study, 50% of patients experienced all fistula closure only one dose of Alofisel. A single dose also shows 42% more efficacy than the treatments previously received by patients (often a combination of Infliximab and immunomodulators).
Takeda plans to launch Alofisel in EU countries soon, as Alofisel’s approval was one of the conditions Takeda had for its offer to aquire TiGenix. Takeda and TiGenix are now waiting for approval from authorities to start the takeover process, which is to happen in just a matter of days.