Artisan Pharma Launches Phase-2b Trial of ART-123 in DIC/Sepsis
[ART-123 is a recombinant form of thrombomodulin, an endogenous protein that binds with thrombin and thereby accelerates the production of protein C via a feedback loop. Thrombomodulin thus has a similar function to antithrombin, but the pathways of these two proteins are distinct.
With 800 patients (vs 200 in Leo’s phase-2 trial), Artisan Pharma’s phase-2b trial has enough statistical power for survival to be the primary endpoint, and indeed it is the primary endpoint (http://www.clinicaltrials.gov/ct/show/NCT00487656 ). Clearly, this is a program that bears close watching by GTC investors.
Artisan Pharma licensed ART-123 from Asahi Kasei Pharma, who retained commercial rights to the drug in Asia and is conducting its own DIC trial in Japan.]
WALTHAM, Mass.--(BUSINESS WIRE)--Artisan Pharma, Inc. today announced that it has launched a Phase 2b clinical trial of its lead product ART-123 for the treatment of DIC in sepsis. The multi-center, double-blind, placebo controlled trial will enroll 800 sepsis patients who are at high risk of having concurrent disseminated intravascular coagulation (DIC), which in sepsis patients may double their risk of death. Clinical sites expected to contribute to the study include those in North America, Europe, Australia, New Zealand, India and Argentina. ART-123 is being developed in Japan by Asahi Kasei Pharma Corporation (“AKP”)(Tokyo, Japan) for the treatment of DIC. Clinical results[i.e. phase-2a]demonstrated that ART-123 has an advantage over heparin in resolving DIC and suggested that ART-123 has an encouraging benefit on mortality in DIC patients with infections.
Commenting on the trial, Jeffrey D. Wager, M.D., President and CEO of Artisan, said, “There are almost 2 million cases of sepsis per year in North America and Europe alone. Up to a third of these cases have DIC secondary to their sepsis. ART-123’s Phase 2b trial is an exciting step towards developing a therapy that could potentially save hundreds of thousands of lives every year. Such an advance would be truly revolutionary in terms of its impact, and inspires all of us here at Artisan.”
David Gelmont, M.D., Artisan’s Chief Medical Officer, continued, “We believe that ART-123 has a very safe profile based on the safety assessments of this drug in previous clinical trials. In addition, data from preclinical and clinical trials suggest that ART-123 is effective in resolving DIC. Current standards of critical care practice implicate the role of DIC as a major contributor to multi-organ dysfunction, organ failure and death in septic patients. We are therefore excited to investigate the possibility that ART-123 might represent a significant intervention in this disease.”
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[I would dispute the use of the word “uniquely” in this context], and holds great promise as a self-regulating treatment of DIC in sepsis. Artisan holds all development and commercial rights for ART-123 outside of Japan, China, Taiwan and Korea.
About DIC in Sepsis
Almost 2 million patients in the United States and Europe suffer from sepsis annually, with approximately 30% of them 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.
About Artisan’s ART-123 Phase 2b Trial in DIC in Sepsis
The phase 2b study entitled “A Randomized, Double–Blind, Placebo–Controlled, Phase-2b Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects with Sepsis and Disseminated Intravascular Coagulation” will enroll 800 subjects in 140 sites, worldwide. For further information please refer to http://clinicaltrials.gov/.
About Artisan Pharma, Inc.
Artisan Pharma is a biopharmaceutical company dedicated to bringing best-in-class acute care therapeutics to patients. Artisan’s strategy is to acquire clinical stage or marketed drugs and develop them for markets with clear unmet medical needs. www.artisanpharma.net
About Asahi Kasei Pharma Corporation
Asahi Kasei Pharma, headquartered in Tokyo, Japan, is a research-based healthcare innovator that discovers, develops, manufactures, and markets products for the pharmaceutical, pharmaceutical intermediate, diagnostics, biopharmaceutical/biological filtration, medical device, medical nutrition, and contact lens markets. Asahi Kasei Pharma is a wholly owned business unit of Asahi Kasei Corporation, a US$13 billion technology company that provides innovative, science-based solutions to a diverse range of markets including chemicals and plastics, apparel, housing and construction, healthcare, and electronics. For additional information, visit www.asahi-kasei.co.jp. <<
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