Catalyst Biosciences Announces Positive Top-Line Data from Phase 1/2 Study of Subcutaneous CB 2679d/ISU304 in Individuals with Hemophilia B
All individuals with severe hemophilia improved to mild hemophilia activity levels after only six daily doses with a continuous linear increase in Factor IX clotting activity
These results suggest that long-term dosing of SQ CB 2679d has the potential to maintain stable clotting activity in the high-mild hemophilia to normal range
Conference call and webcast to be held today,
“These exciting results demonstrate for the first time the feasibility of a subcutaneous FIX injection to provide meaningful protection from bleeding, even after only six doses,” said Dr.
Dr. Levy remarked, “Existing IV therapies have FIX trough levels that can drop as low as 1-3% before repeat dosing. Daily subcutaneous dosing of CB 2679d has the potential to minimize the variability in FIX activity levels observed between IV doses and maintain individuals in the mild or even normal hemophilia range. This study demonstrates that, even after just six days of treatment, CB 2679d compares favorably to currently approved therapies for hemophilia B, all of which are infused IV.”
Conference Call and Webcast
The management team will host a conference call with slides for investors today,
Conference ID: 8902500
Replay will be available two hours after completion of the call through
Replay ID: 8902500
The call will also be archived on the Company’s website for 30 days at www.catalystbiosciences.com.
About the FIX Phase 1/2 Trial
CB 2679d is designed as a best-in-class high potency recombinant Factor IX product. The Phase 1/2 clinical trial of CB 2679d in patients with severe hemophilia B was conducted at three centers in
Hemophilia, for which there is no cure, is a rare but serious bleeding disorder that results from a genetic or an acquired deficiency of a protein required for normal blood coagulation. The severity of the disease is defined according to the percentage of normal factor activity in blood (50-150%). According to the definitions of the
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 facts, included in this press release regarding our strategy, the potential uses and benefits of CB 2679d and development plans for this product candidate 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 to normal range. Actual results or events could differ materially from the plans and expectations and projections disclosed in these forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Catalyst makes, including, but not limited to, the risk that subsequent clinical trials will not replicate the results from initial clinical studies with small numbers of patients, that multiple subcutaneous dosing of CB 2679d may result in potential adverse effects, including the generation of neutralizing antibodies (inhibitors), the risk that costs required to develop or manufacture Catalyst’s products will be higher than anticipated, competition, and other factors described in the “Risk Factors” section of the Company’s most recent Quarterly Report on Form 10-Q filed with the
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