Catalyst Biosciences Provides Update on CB 2679d/ISU304 Factor IX Clinical Program in Hemophilia B
Subsequent blood samples showed the presence of a transient neutralizing antibody in one patient and a neutralizing antibody in the second. Importantly from a safety perspective, the antibodies do not bind to wildtype FIX allowing both patients to successfully resume treatment with their prescribed intravenous FIX prophylaxis therapies; the patients have not experienced any bleeds or other safety issues and are being closely monitored. Prior to Cohort 6, no CB 2679d neutralizing antibodies had been detected in any of the patients treated with CB 2679d/ISU304, including both patients in Cohort 6 who had also participated in Cohort 5. Catalyst is conducting an analysis to assess the cause and impact of the antibody observations prior to dosing any further subjects in Cohort 6.
“The most recent data from the ongoing Phase 1/2 trial have demonstrated clinical proof of concept for subcutaneous dosing of a potent FIX as a treatment for hemophilia B. Patients in Cohort 6 of the trial were able to maintain Factor IX levels over 30% which is at the upper end of mild hemophilia and higher than currently approved extended half-life (EHL) intravenous Factor IXs,” said
Catalyst’s Phase 2 study of daily subcutaneous injections of its next generation Factor VIIa marzeptacog alfa (activated) for the treatment of hemophilia A or B with inhibitors and Catalyst’s preclinical dry age-related macular degeneration (dry AMD) programs are continuing to progress as planned. Catalyst’s cash balance as of
About the FIX Phase 1/2 Trial
CB 2679d/ISU304 was designed as a best-in-class high potency recombinant Factor IX (FIX) product. Catalyst believes that CB 2679d/ISU304 may provide a subcutaneous prophylactic treatment for individuals with hemophilia B by achieving high-mild hemophilia FIX activity levels in blood. The Phase 1/2 clinical trial of CB 2679d/ISU304 in patients with severe hemophilia B is being conducted at three centers in
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Catalyst is a clinical-stage biopharmaceutical company developing novel medicines to address hematology indications. Catalyst is focused on the field of hemostasis, including the subcutaneous prophylaxis of hemophilia and facilitating surgery in individuals with hemophilia. For more information, please visit www.catalystbiosciences.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statement of historical fact, included in this press release regarding our strategy, the potential uses and benefits of CB 2679d and development plans for this candidate and other candidates are forward-looking statements. Examples of such statements include, but are not limited to, the potential for subcutaneous dosing of CB2679d to maintain clotting activity in the high-mild hemophilia range, the lack of binding of CB 2679d neutralizing antibodies with wildtype FIX and plans to analyze the cause of neutralizing antibodies in patients treated with CB 2679d. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements as a result of various important factors, including, but not limited to, the risk that the development program for CB 2679d may be significantly delayed or suspended or may not have satisfactory outcomes, that Cohort 6 will not replicate the results from earlier human trials (including Cohort 5) or from prior animal studies, that potential adverse effects may arise from the testing or use of the Company’s products, including the generation of antibodies, the risk that costs required to develop or manufacture the Company’s products will be higher than anticipated, competition and other factors described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended
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Source: Catalyst Biosciences, Inc.