Asahi Kasei Pharma America Initiates Phase 3 Clinical Trial for ART-123 in Severe Sepsis Patients with Coagulopathy
<0> For AKP AmericaNaoyuki Ono, 781-419-5037orMacDougall Biomedical CommunicationsDouglas MacDougall, 781-235-3060 </0>
(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.
The Phase 3 clinical trial is a randomized, double-blind, placebo-controlled safety and efficacy study that will enroll approximately 800 patients from multiple centers worldwide. The primary efficacy outcome measure is 28-day all-cause mortality, and primary safety outcome measures include serious adverse events, adverse events and major bleeding events. Secondary efficacy outcome measures include all-cause mortality at three months and resolution of organ dysfunction, while the secondary safety outcome measure is presence of anti-drug antibodies.
ART-123 is a novel, recombinant, human soluble thrombomodulin for the treatment of severe sepsis with coagulopathy. ART-123 uniquely targets both anti-coagulant and systemic anti-inflammatory pathways, and holds great promise as a self-regulating treatment of coagulopathy in sepsis. ART-123 is approved for marketing in Japan for the treatment of disseminated intravascular coagulation (DIC).
Asahi Kasei Pharma America (AKP America), a wholly owned subsidiary of Asahi Kasei Pharma, Corp., is a biopharmaceutical company dedicated to bringing best-in-class critical care therapeutics to patients throughout the world.