Artisan Pharma, Inc., a private biopharmaceutical company dedicated to bringing best-in-class critical care therapeutics to patients, announced the completion of patient enrollment in its Phase 2b study of ART-123 (Recomodulin® – recombinant human thrombomodulin) in sepsis patients with disseminated intravascular coagulation (DIC). The clinical trial was a randomized, double-blind, placebo-controlled Phase 2b study to assess the safety and efficacy of ART-123 in patients with sepsis and DIC. The clinical study enrolled 750 patients in over 150 sites worldwide.
“DIC in sepsis is a severe condition with a very poor prognosis for patients,” stated Dr. Inder Kaul, M.D., M.P.H., Chief Medical Officer of Artisan Pharma. “We are energized at having reached this milestone and now will be focusing on preparing to analyze the results, which are highly anticipated by the medical and scientific communities.”
“We are very pleased to have achieved this important milestone for Artisan and expect to report the results later this year,” commented Dr. Gary T. Shearman, Executive Chairman.
About ART-123
ART-123 is a novel, recombinant, soluble thrombomodulin for the treatment of DIC (disseminated intravascular coagulation) in sepsis. ART-123 uniquely targets both anti-coagulant and systemic anti-inflammatory pathways, and holds great promise as a self-regulating treatment of DIC in sepsis. Artisan licensed ART-123 from Asahi Kasei Pharma Corporation and holds all development and commercial rights for ART-123 outside of Japan, China, Taiwan and Korea. ART-123 is approved for marketing in Japan for the treatment of DIC.
About DIC in Sepsis
Almost 2 million patients in the United States and Europe suffer from sepsis annually, with up to 30% of them developing or being at high risk of developing DIC. For those that do, prognosis is poor. DIC is a severe condition in which widespread microthrombi formation ultimately contributes to organ dysfunction and death. This market is estimated at over $2 billion and is increasing due to the growing incidence of sepsis in the industrialized world.
Source
Artisan Pharma, Inc.