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Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B

IB1001, an Intravenous Recombinant Factor IX (rFIX) Product for the Treatment of Hemophilia B

LAGUNA NIGUEL, Calif., Feb. 12 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc., today announced the initiation of a Phase 1 clinical trial of IB1001, an intravenous (IV) recombinant Factor IX (rFIX) product for control and prevention of hemorrhagic episodes in patients with hemophilia B. It is estimated that the market for therapies to treat this disorder is in excess of $600 million.

The Phase 1 clinical trial is designed to assess the safety, tolerability and pharmacokinetics of IB1001 in patients with hemophilia B, compared with the commercially available rFIX product. Following the successful completion of this study, patients will then be followed for the six month Phase 2/3 trial either based on an on-demand or prophylaxis protocol.

"The initiation of this Phase 1 trial is an important milestone for the Company and for the hemophilia community," said John Taylor, Chairman and Co-founder, Inspiration Biopharmaceuticals. "This is the first therapy for hemophilia B patients in the past two decades. We continue to develop a Factor product portfolio in both IV and non-invasive dosage forms for hemophilia and other coagulation disorders."

About IB1001

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.

About Hemophilia

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 entering clinical studies in the United States and is poised to enter clinical testing in Europe and Israel.

SOURCE Inspiration Biopharmaceuticals, Inc.
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