LAGUNA NIGUEL, Calif., Dec. 12, 2011 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) has presented key scientific data from the Company's two lead hemophilia development programs - IB1001, a recombinant factor IX (FIX) product, which is in clinical trials for the treatment and prevention of bleeding in individuals with hemophilia B; and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, which is being evaluated for the treatment of individuals with congenital hemophilia A who have inhibitors against human FVIII, and for individuals with acquired hemophilia A. The data were highlighted in poster presentations at the 53rd Annual Meeting of the American Society of Hematology (ASH) in San Diego, California.
In a poster presentation titled, "Pharmacokinetic Behavior of IB1001, An Investigational Recombinant Factor IX, in Patients with Hemophilia B: Repeat Pharmacokinetic Study and Subgroup Analysis", newly reported data from a subset of patients who underwent a second pharmacokinetic (PK) evaluation with IB1001 demonstrated the PK profile of IB1001, following prophylaxis over periods ranging from 4 to 18 months, was similar to the profile established during the initial phase of the study. Importantly, these findings indicate there was no evidence of development of inhibitors during prophylactic treatment. The initial randomized cross-over PK study demonstrated that IB1001 is at least as good as BeneFIX®, the only approved recombinant FIX product for the treatment of hemophilia B in achieving circulating levels of factor IX.
Ed Gomperts, M.D., Medical Director of Inspiration Biopharmaceuticals, commented, "One of Inspiration's primary missions is to improve access to care, including prophylactic therapy for patients with hemophilia. These new data suggest IB1001 may be safely and effectively administered during prophylaxis therapy to prevent bleeds and on demand when bleeds occur. These data confirm results previously reported by investigators at the ISTH meeting in July 2011, which suggested that IB1001 is at least as good as the existing, marketed recombinant FIX product. In addition, no inhibitors have been observed to date in clinical studies involving IB1001.
"Currently, individuals with hemophilia B are limited to only one approved recombinant product. An alternative recombinant FIX product, such as IB1001, will increase product availability and choice, and help encourage the use of optimal therapeutic regimens such as prophylaxis."
A second poster presentation, titled "Recombinant Porcine Factor VIII Corrects Thrombin Generation and Improves Clot Structure In Vitro in Plasma Containing Anti-Factor VIII Inhibitory Antibodies", further characterized the in vitro capacity of OBI-1 to correct surrogate markers of hemostasis depending on the anti-porcine FVIII titer. Results were presented from blood samples of 14 individuals with congenital hemophilia. OBI-1 corrected thrombin generation when added to hemophilia A plasma samples with low and mid OBI-1 inhibitor titers. These in vitro data suggest that this correction is correlated with the OBI-1 inhibitor levels and not the human FVIII inhibitor levels. The data also suggest that OBI-1 may potentially restore thrombin generation in the presence of an OBI-1 inhibitor titer higher than 10 BU/mL.
Dr. Gomperts commented, "We are very encouraged by the OBI-1 study results. OBI-1, which may possess low cross reactivity to antihuman FVIII antibodies, facilitates the intrinsic hemostatic pathway. This may allow clinicians to correlate activity and efficacy with FVIII levels and therefore guide dosing to better monitor and predict treatment outcomes."
John P. Butler, Chief Executive Officer of Inspiration Biopharmaceuticals, stated, "We are very pleased with the positive momentum of our IB1001 and OBI-1 development programs. In October, we announced the acceptance for review of our Marketing Authorization Application (MAA) filing for IB1001 in the E.U., and we have a subsequent regulatory filing planned in the U.S. Additionally, we recently initiated the second of two pivotal clinical studies of OBI-1. These two late-stage products, along with our earlier-stage hemophilia pipeline, address the need for broader access to hemophilia care worldwide and improved treatment options for people with inhibitor complications. We look forward to continued progress with both of these programs as they advance towards commercialization."
About Hemophilia Hemophilia is a bleeding disorder caused by low levels or the absence of a protein called a coagulation factor, essential for blood clotting. The two most common forms of hemophilia are types A and B. Hemophilia A is caused by a factor VIII deficiency and the congenital form occurs in ~1 out of every 5,000 male births. Hemophilia B is caused by factor IX deficiency and occurs in ~1 out of every 30,000 male births. Hemophilia is a very rare event in females. Approximately 60% of persons with hemophilia have a severe condition, which results in frequent spontaneous bleeding episodes, in addition to serious bleeding after injuries. The annual market for hemophilia treatments is estimated at $8 billion worldwide.
Approximately one-third of individuals with hemophilia A develop an immune reaction (inhibitors) to human FVIII, and can no longer respond to replacement treatment with the human coagulation factor. Current therapies, specifically human factor VIIa (NovoSeven®) and FEIBA, work by bypassing the natural hemostatic pathway.
About Inspiration Biopharmaceuticals Inspiration Biopharmaceuticals is dedicated exclusively to developing treatments for hemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve the treatment of individuals with inhibitor complications. Inspiration has a broad portfolio of recombinant hemophilia products, which includes two products in late-stage clinical development and two preclinical programs.
Inspiration's two lead programs are IB1001, an intravenous recombinant factor IX (FIX) product being developed for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product being developed for the treatment of individuals with congenital hemophilia A who have inhibitors against human FVIII and for individuals with acquired hemophilia A. Inspiration recently submitted its first marketing application for IB1001 in Europe, with a subsequent regulatory filing planned in the U.S in the first half of 2012. Earlier-stage preclinical programs at Inspiration are focused on human recombinant factor VIIa (FVIIa), for individuals with either hemophilia A or hemophilia B who have developed inhibitors, and for individuals with factor VII deficiency; and human recombinant FVIII, to treat individuals with hemophilia A.
Inspiration has extensive expertise and experience in hemophilia product development, biologics manufacturing, regulatory submissions and global commercialization. The Company's senior leadership was directly responsible for the development and commercialization of the majority of hemophilia products currently on the market.
In addition, in January 2010, Inspiration entered into a strategic partnership with the Ipsen Group (EURONEXT: IPN; ADR: IPSEY), leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products. As announced in late August 2011, Ipsen and Inspiration extended their partnership to create a hemophilia business unit structure that will act as the exclusive sales organization for all hemophilia products commercialized under the Inspiration brand in Europe. For further information on Inspiration, please visit http://www.inspirationbio.com.
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