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Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
Date:11/13/2007

LAGUNA NIGUEL, Calif., Nov. 13 /PRNewswire/ -- Inspiration Biopharmaceuticals announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical trials with IB1001, an intravenous recombinant Factor IX (rFIX) product for the on demand and prophylactic treatment of the bleeding disorder associated with hemophilia B.

Upon FDA approval of the IND application, Inspiration Biopharmaceuticals intends to enter Phase 1/2 clinical trials to evaluate the pharmacokinetics (PK) and safety profile of IB1001, compared with the commercially available Factor IX products; rFIX, BeneFix(R) and plasma-derived Factor, MonoNine(R). Following successful completion of the PK phase of this study, patients will then enroll in one of two trials: a six month Phase 1/2 On Demand trial to document safety and efficacy in treating spontaneous bleeding episodes or a pivotal Phase 2/3 Prophylaxis trial to document safety and efficacy in the prevention of spontaneous bleeding. In addition, the safety and efficacy of peri-surgical prophylactic administration of IB1001 to control bleeding during surgical procedures will be evaluated. The rate of inhibitor formation will be evaluated throughout all phases of the clinical investigation of IB1001.

"We are excited to be filing an IND for IB1001," said Michael Griffith, Ph.D., President and CEO, Inspiration Biopharmaceuticals. "Preclinical studies have demonstrated the expected PK and safety profile for IB1001 when compared to the clinically proven commercial Factor IX products. Our cost-effective manufacturing platform for Factor IX positions Inspiration to expand the global supply of i.v. rFIX and to develop next generation products to facilitate prophylactic care of the hemophilia B patients worldwide. Our ultimate goal is to leverage our low cost manufacturing technology to find the means for non-invasive delivery of Factor IX which we believe may represe
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SOURCE Inspiration Biopharmaceuticals
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