On a day when stock markets tumbled, TiGenix (EBR:TIG) saw its share price jump by more than 20% on the strength of data it thinks represents the first time an allogeneic stem cell therapy has aced Phase III. And having hit the primary endpoint in the study, TiGenix is now preparing to take its drug for treatment-resistant fistulas in people with Crohn's disease to regulators.
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| TiGenix CEO Eduardo Bravo |
Leuven, Belgium-based TiGenix expects to take its data to European regulators early next year. The case for approval will be underpinned by data from a 289-person Phase III trial, in which the complex perianal fistulas of half of the participants who received Cx601 were in remission after 24 weeks. A little more than one-third of the patients in the placebo arm had such a response. TiGenix calculated that people who received the allogeneic expanded adipose-derived stem cell treatment Cx601 had a 44% greater chance of achieving combined remission than those who were given the placebo.
If TiGenix can win approval and replicate the result in the real world, it could provide a new therapy option for people who have failed to respond to other treatments. The 289 people in the Phase III trial had previously had inadequate responses to other treatments, mostly anti-tumour necrosis factor drugs such as Johnson & Johnson's ($JNJ) Remicade. "Achieving more than 50% combined remission in patients who have not responded adequately to previous treatments, including anti-TNFs, is a remarkable accomplishment," TiGenix CMO Marie Paule Richard said in a statement.
TiGenix thinks the data are strong enough to win over regulators in Europe, where a launch in the back half of 2017 is being targeted. The plan is to find a partner for commercialization, while keeping at least co-promotion rights in some European markets. TiGenix also now has enough confidence in the asset to push ahead with a pivotal study for the U.S. market. The firm was sat on €13.5 million ($15.5 million) in cash at the end of 2014 but has since topped up its coffers through a €25 million convertible bond, extending its runway out beyond the previously-discussed cut off of September.
- read the release