Cx601 – EU
In December 2017, Cx601, received a positive CHMP opinion in Europe for the treatment of complex perianal fistulas in adult Crohn’s disease patients that have previously shown an inadequate response to at least one conventional therapy or biologic therapy. The opinion was based on the data from a European Phase III clinical trial (ADMIRE-CD), which was completed in August 2015.
In July 2016 TiGenix published the 24 week results of this pivotal phase III trial in The Lancet in July 2016.
This trial was designed as a randomized, double-blind Phase III study in Europe and Israel. The study enrolled a total of 212 patients with non-active or mildly-active Crohn’s disease with inadequate response to previous therapies.
At week 24, the rate of combined remission in patients treated with Cx601 compared with patients who received placebo was statistically significant, meeting the primary endpoint of combined remission of complex perianal fistula. In the ‘intention to treat,’ or ITT, population, 49.5% of patients treated with Cx601 had combined remission compared to 34.3% in the placebo arm. The trial’s results indicated that patients receiving Cx601 had a 44.3% greater probability of achieving combined remission than placebo patients. Moreover, the trial confirmed a favorable safety and tolerability profile, while treatment-adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between the Cx601 and placebo arms.
The results of the follow-up analysis after 52 weeks were also positive: A single administration of Cx601 was statistically superior to placebo in achieving combined remission in 54.2% of patients treated with Cx601 compared to 37.1% of patients in the placebo arm. In addition, after 52 weeks, 75.0% of patients treated with Cx601 who were in combined remission at week 24 did not relapse, compared to 55.9% for patients in the placebo arm who were in combined remission at week 24. The results also confirmed the favorable safety and tolerability profile of Cx601.
Further long term extension data confirmed the long term safety and tolerability of Cx601.
The topline data of a second year of follow up for 37 patients indicated that the clinical remission rate and difference between groups, as was previously observed at week 24 and week 52, as well as the tolerability of Cx601, was maintained at week 104, confirming the safety and durability of the treatment.
More information on this trial is available here:
Takeda, a global leader with strategic focus in gastroenterology (GI) who acquired ex – US development and commercialization rights to Cx601 for the treatment of complex perianal fistulas in Crohn’s disease patients in July 2016
Ministry of Economy and Competitiveness: The ADMIRE-CD study was partly financed through a EUR 4.95 million soft loan from the ‘Madrid Network’, granted in October 2011. ‘Madrid Network’ is an organization within the Autonomous Region of Madrid which helps companies to grow through high-technology innovation. The program is funded by The Secretary of State for Research, Development and Innovation (Ministry of Economy and Competitiveness) within the framework of the INNTEGRA plan.