ART 123 (recombinant human thrombomodulin alpha, marketed as Recomodulin® in Japan), our lead product candidate, represents a promising new treatment for severe sepsis with coagulopathy. This drug has successfully completed a Phase 2b clinical trial in disseminated intravascular coagulation (DIC) and Phase 3 trial is underway. This product might also be beneficial for a number of other indications.
clinicaltrials.gov: Safety and Efficacy Study of ART-123 in the Treatment of Severe Sepsis With Coagulopathy
From the CEO: ART-123 Updates
Asahi Kasei Pharma America is pleased by the progress our team has made in advancing ART-123 for the treatment of severe sepsis with coagulopathy. Severe sepsis, which affects nearly two million people in the U.S. and Europe each year, is the most common cause of death in critically ill patients and is associated with even higher mortality when coagulopathy is present. New medicines are vitally needed. Below is a summary of recent progress that our team has made in our efforts to advance ART-123 as a potential treatment for critical care patients with sepsis.
- In late 2012, we initiated a Phase 3 trial for ART-123 in severe sepsis patients with coagulopathy. This randomized, double-blind, placebo-controlled trial is enrolling 800 patients from multiple centers worldwide and will evaluate the safety and efficacy of the drug. More information on this trial can be found here. ART-123 is approved and marketed in Japan as Recomodulin® for the treatment of disseminated intravascular coagulation.
- This summer, the data monitoring committee for the Phase 3 trial completed an interim safety review of the data from the study and recommended that the trial continue.
- The Phase 3 trial follows a successful 750-patient Phase 2b study of ART-123, results from which were published in the September 2013 issue of Critical Care Medicine. These results demonstrated that ART-123 is a safe treatment for critically ill patients with sepsis and suspected disseminated intravascular coagulation, with no difference from placebo on safety measures such as major bleeding events. The data also provided evidence suggestive of efficacy of the treatment and supported further advancement of the drug. More information on this publication can be found here.
- Asahi Kasei Pharma America is committed to the continued advancement and ultimate success of ART-123 and we look forward to providing updates on the progress of this program.
-Kazuhisa Tsuruta, Ph.D., President, Chief Executive Officer and Chief Scientific Officer of Asahi Kasei Pharma America