GENEVA, Feb. 3, 2011 /PRNewswire/ — Inspiration
Biopharmaceuticals, Inc. (Inspiration) today presented
pharmacokinetic (PK) data on its lead product, IB1001, a
recombinant factor IX (FIX) for the treatment and prevention of
bleeding in individuals with hemophilia B. Results of the
Phase 1 portion of an ongoing IB1001 clinical study demonstrated
non-inferiority of IB1001 in achieving overall levels of
replacement factor compared to BeneFIX®, the only approved
recombinant FIX product for the treatment of hemophilia B.
Currently, IB1001 is in Phase 3, with safety and efficacy
results expected later this year.
The clinical results were presented at the 4th Annual Congress
of the European Association for Haemophilia and Allied Disorders
(EAHAD) in Geneva, Switzerland, in a poster presentation titled,
“Pharmacokinetics of IB1001, a New Recombinant Factor IX”.
Ed Gomperts, M.D., Medical Director of Inspiration
Biopharmaceuticals, commented, “We are very encouraged by the
clinical results for IB1001, which showed PK results at least as
good as the existing, marketed recombinant FIX product.
Further, the findings were similar in terms of half-life and
in vivo recovery, which is fundamental for the determination
of dose for the prevention and treatment of spontaneous bleeds, as
well as trauma associated with surgical procedures.”
Dr. Gomperts continued, “There remains a large gap in hemophilia
treatment, with access to care primarily limited by availability
and cost of therapy. New initiatives are greatly needed
globally. Pending approval, a new recombinant FIX product
such as IB1001 will increase product availability and thus should
improve access to care, including prophylactic therapy of
hemophilia B in a market where recombinant FIX is limited to only
one approved product.”
“We are pleased with the continued progress of the IB1001
program,” stated Michael Griffith, Ph.D., President and CEO of