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Catalyst Reports Positive Results in First Clinical Trial Group to Receive Subcutaneous FIX Therapy

September 25, 2017
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San Francisco-based Catalyst Biosciences, Inc. recently announced positive clinical data from the first group of patients participating in an ongoing Phase 1/2 proof-of-concept study in individuals with severe hemophilia B. The trial, which is being conducted at three centers in South Korea, is designed to evaluate Catalyst’s investigative, subcutaneous factor IX (FIX) therapy known as CB 2679d. Catalyst develops its therapies using engineered proteases, enzymes that increase the rate of chemical reactions within cells. These proteases can target the proteins associated with certain underlying diseases and conditions, such as FIX.

According to a company press release, subcutaneous injections of the therapy boosted FIX in hemophilia B patients to therapeutically significant levels. The release also highlighted the potency and advanced pharmacokinetics of CB 2679d. Specifically, results showed that an intravenous dose of CB 2679d was approximately 22 times more potent than an intravenous dose of the recombinant FIX product BeneFIX® and that the average time that CB 2679d stayed in the circulation was significantly longer compared to BeneFIX® (34 hours vs 25 hours). The results were presented at the 26th International Society on Thrombosis and Haemostasis Meeting, July 8-13, 2017, in Berlin, Germany.

“The positive results that we reported earlier this month from Cohort 1 demonstrated the drug potency and circulation profile that we believe will support subcutaneous prophylaxis and may normalize factor IX levels. Results from the Phase 1/2 trial will be reported at upcoming medical conferences,” said Nassim Usman, PhD, Catalyst’s President and Chief Executive Officer. “Currently approved hemophilia B therapies require frequent intravenous infusions and do not result in sustained normalization of Factor IX activity – we aim to change this treatment paradigm.”

The company plans on releasing additional interim trial data by the end of 2017.

Source: Catalyst press release dated September 25, 2017