Tigenix announced today the enrolment of the first patients in the ADMIRE-CD trial, its pivotal Phase III clinical trial with Cx601 in perianal fistulas in Crohn's disease patients at Hospital Clínic, Barcelona, Spain. Cx601 is an adipose derived allogeneic stem cell therapy.
As a reminder, ADMIRE-CD stands for “Adipose Derived Mesenchymal stem cells for Induction of REmission in perianal fistulising Crohn's Disease”. ADMIRE-CD is a multicenter, randomized, double-blind, placebo-controlled Phase III trial of Cx601 in approximately 200 Crohn's disease patients suffering from complex perianal fistulas. The main objectives of the study are to demonstrate safety and superior efficacy over placebo in perianal fistulas in Crohn's disease patients after failure with their previous treatment, in most cases biologicals, and to confirm the strong safety and efficacy results from the Phase II trial completed in 2011. To date, Tigenix has already received approvals in 7 out of 8 countries, which should allow Tigenix to accelerate patient enrolment in the study.
Final results of ADMIRE-CD are expected towards the end of 2014. Tigenix has received a € 5m soft loan from Madrid Network to support funding of the Phase III trial.
The guidance for full results reporting stands at 'end of 2014', which is a small difference versus our best case scenario forecast of 'mid 2014'. In order to achieve this guidance, all 200 patients will be required in the coming 18-24 months, with patient enrolment finished by mid 2014. While enrolling 200 patients over this period of time may not seem that much, we remind investors that complex perianal fistulas is a rare disorder, with an estimated 50,000 cases per year in the European territory.
HOLD rating and € 0.95 target price reiterated.