LAGUNA NIGUEL, Calif., July 14 Inspiration Biopharmaceuticals today announced the presentation of positive preclinical safety, toxicology and preliminary pharmacokinetic data on its lead product, IB1001, a novel recombinant Factor IX product to treat patients with hemophilia B. The data were highlighted in an oral presentation yesterday at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Boston, Mass. IB1001 has completed preclinical testing and is currently being evaluated in a Phase 1/2-3 clinical study.
In the study, the safety, toxicology and pharmacokinetics of IB1001 were evaluated in animal models and compared to commercially available Factor IX products. Results showed that IB1001 has an excellent safety profile in animal models and a similar pharmacokinetic profile when compared to currently available Factor IX products.
"These results and the progress that we have made in advancing our protein manufacturing technology have facilitated the advancement of IB1001 into a Phase 1/2-3 clinical program," said Michael Griffith, Ph.D., President and CEO, Inspiration Biopharmaceuticals. "Our ultimate goal is to increase accessibility to prophylactic treatment and improve the quality of life for people suffering from hemophilia around the world. We expect to move IB1001 into a pivotal trial and look forward to updating you on all developments related to this program."
IB1001 is an intravenous recombinant Factor IX product for the acute and preventative treatment of the bleeding disorder associated with hemophilia B. IB1001 is produced with Inspiration's proprietary recombinant protein manufacturing technology, which significantly increases cell-line productivity.
Hemophilia is a lifelong, inherited bleeding disorder caused by low levels or absence of a protein called a clotting factor, essential for blood clotting. This inability to clot results from an error in a person's genetic code, and occurs in approximately 1 in 10,000 male births. It is estimated that over 400,000 people worldwide suffer from hemophilia, of which only 25% currently receive therapy. It is estimated that the market for hemophilia treatment is in excess of seven billion dollars annually. There are two types of hemophilia, hemophilia A and hemophilia B. Hemophilia A is caused by a lack of Factor VIII and hemophilia B is caused by a deficiency of Factor IX.
About Inspiration Biopharmaceuticals
Inspiration Biopharmaceuticals was founded in 2004 with the mission to revolutionize treatments for hemophilia. The Company is focused on developing products that have the potential to broaden patient access to therapy, including prophylactic use. Greater access and more frequent prophylactic therapy have been shown to reduce complications of the disease and enhance patients' long-term health and quality of life.
Underlying the Company's programs is a novel, proprietary manufacturing technology that allows a greater yield of high-quality protein. Inspiration is utilizing this technology to develop a portfolio of hemophilia and bleeding disorder products that address a $7 billion market worldwide. Inspiration's lead product candidate IB1001, an intravenous recombinant Factor IX, has completed preclinical testing and is now being evaluated in a Phase 1/2-3 clinical study in the United States and Israel and is poised to enter clinical testing in Europe.
SOURCE Inspiration Biopharmaceuticals