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news.IB1001 has an excellent safety profile in animal models and a similar pharmacokinetic profile, compared toFactor IX products
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Inspiration Biopharmaceuticals has announced the positive preclinical safety, toxicology and preliminary pharmacokinetic data on IB1001. Its a novel recombinant Factor IX product intended to treat patients with hemophilia B.
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, 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.
Michael Griffith, president and CEO of Inspiration Biopharmaceuticals, said: 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.
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, he added.
The data were presented at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Boston.