Initiation of a Global Phase III Clinical Trial for ART-123

October 29, 2012
Asahi Kasei Pharma Corp.

Asahi Kasei Pharma America Corp., a wholly owned subsidiary of Asahi Kasei Pharma, has begun a global Phase III clinical trial for ART-123 (recombinant thrombomodulin alpha, marketed as Recomodulin™ in Japan.) The trial will examine the safety and efficiency of ART-123 in patients with severe sepsis and coagulopathy.

ART-123 is an intravenous anticoagulant developed by Asahi Kasei Pharma, and it has been sold in Japan since 2008. To advance its overseas development, Asahi Kasei Pharma established Artisan Pharma, Inc. in 2006, together with several venture capital firms. Artisan Pharma completed a global Phase IIb clinical trial for ART-123 in 2010. In November 2011, Asahi Kasei Pharma acquired all shares in Artisan Pharma, making it a wholly owned subsidiary and changing its name to Asahi Kasei Pharma America.

The global Phase III clinical trial for ATR-123 is a randomized, double-blind, placebo-controlled study conducted in the US, South America, Asia, Australia, and other countries. A total of 800 patients are scheduled to be enrolled in the study.

About ART-123 (Recomodulin™)

Recomodulin™ is a thrombomodulin agent manufactured using genetic recombination technology. It acts as an anticoagulant by suppressing the activity and production of thrombin, a blood coagulation factor. Reports in recent years indicate that thrombomodulin also has anti-inflammatory effects.

About coagulopathy

Coagulopathy is a systemic state of excessive coagulation. In patients with sepsis, endotoxins can hyperactivate the coagulation system by exciting the inflammatory cytokine network, resulting in coagulopathy.

About sepsis

Sepsis is a medical condition that is characterized by a whole-body inflammatory state caused by an infection. Without treatment, sepsis will almost certainly lead to death due to shock, DIC, multiple organ dysfunction, etc. Even with treatment, prognoses have not generally been favorable, as sepsis tends to occur in patients whose physical condition is already severely compromised.


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