In early May 2008, Catalyst Biosciences, Inc., announced the development of an improved second-generation variant of human coagulation factor VIIa for the treatment of acute bleeding in hemophilia patients. The drug candidate, CB 813, is being developed using Alterase™, Catalyst’s patented protease technology.
Proteases, enzymes that cause the hydrolytic breakdown of proteins into peptides or amino acids, are often used as therapeutics for several diseases, including age-related macular degeneration, cancer and hemophilia. CB 813 boosts clot-generating activity at the bleeding site, achieving “clinical efficacy” with fewer and lower doses than existing therapies. According to the San Francisco, CA-based company, CB 813 demonstrated significant improvement in potency when compared with Novo Seven®, a recombinant factor VIIa product manufactured by Novo Nordisk, and a competing second-generation product, NN1731.
“Patients receiving factor VIIa therapy typically require multiple doses of drug and extended treatment times to manage acute bleeding episodes,” said Gilbert C. White, II, MD, executive vice president for research and director of the Blood Research Institute, BloodCenter of Wisconsin. “I am excited by the potential shown by CB 813 to improve the efficiency of treatment by achieving a faster onset and an extended duration of therapeutic benefit to patients. These advantages may significantly reduce both the number of doses and treatment time required to manage bleeding and restore normal hemostasis.”
Catalyst plans to file an Investigational New Drug application for CB 813 with the U.S. Food and Drug Administration. It will begin clinical studies in hemophilia patients in 2009.
Source: Medical New Today, May 7, 2008