ART-123, also known as human recombinant thrombomodulin, is from a class of protein C stimulants currently being developed by Asahi Kasei for acute exacerbation of idiopathic pulmonary fibrosis (IPF).

ART-123 has been approved in Japan for the treatment of disseminated intravascular coagulation (DIC) since 2008. Thrombomodulin is present on the surface of vascular endothelial cells and serves as an anticlotting factor responsible for the regulation of blood coagulation.

ART-123 inhibits the coagulation process by accelerating the activation of protein C by thrombin. The activated protein C degrades key factors in the clotting cascade, using protein S as a coenzyme and inhibits coagulation by reducing thrombin generation.

ART-123 research in PF

A prospective study has been conducted with 22 participants with acute flares of idiopathic interstitial pneumonia. Half of the participants were treated with ART-123, the other half without. The primary objective of this study was the measure of the mortality rate at 90 days after treatment. The secondary objective was the safety of the treatment in these flares. The mortality rate was slightly lower in the treated group than in the placebo group, with no serious events observed.

A Phase 3 clinical trial is currently underway (NCT02739165) to assess the effectiveness and safety of intravenous treatment of ART-123 in people with acute flares of IPF. This multicenter, double-blind, placebo-controlled trial’s objective is to confirm the drug candidate’s superiority over placebo with survival rate after 90 days. The participants will receive either 380 units/kg a day by intravenous drip infusion in addition to standard of care steroid therapy or placebo.

The study’s estimated completion date is March 2018.

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