Asahi Kasei Pharma America Corp. (AKP America) today announced the initiation of an 800-patient Phase 3 clinical trial for ART-123 (recombinant human thrombomodulin, marketed as Recomodulin® in Japan) in severe sepsis patients with coagulopathy. The Phase 3 trial follows a successful 750-patient randomized, double-blind, placebo-controlled Phase 2b study that assessed the safety and efficacy of ART-123.
"Sepsis affects nearly two million patients in the United States and Europe each year, and the prognosis for those patients with coagulopathy is quite poor," said Dr. Inder Kaul, AKP America's President of Product Development and CMO, and the medical monitor for the Phase 3 study. "A clear clinical need exists for this patient population, and I believe that ART-123 is the first truly promising drug candidate that has emerged recently for this difficult indication. The promise that this product holds becomes even more critical in lieu of the recent disappointments faced by other pharmaceutical companies. I am gratified to be involved in this clinical trial, which will potentially bring ART-123 one step closer to patients suffering from severe sepsis."
"The initiation of this large, multi-center trial is a significant milestone for AKP America as we move closer to potential commercialization in the United States. The strong sales of this drug in the Japanese market demonstrate not only the clinical need for ART-123, but also its market potential," said Mr. Naoyuki Ono, President and Chief Executive Officer of AKP America.
Asahi Kasei Pharma America