Catalyst Biosciences Announces Issuance Of Asia Patents Covering Factor IX Hemophilia Program
Published: Sep 11, 2017
-- CB 2679d/ISU304 has patent coverage in all key commercial territories --
SOUTH SAN FRANCISCO, Calif., Sept. 11, 2017 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (Nasdaq:CBIO), today announced that it has been issued patents covering its coagulation Factor IX hemophilia product candidate from the State Intellectual Property Office (SIPO) in the People's Republic of China, the Intellectual Property Office of Singapore (IPOS), and the Taiwan Intellectual Property Office (TIPO). The patents cover both modified Factor IX polypeptides and uses thereof, and build on the Company’s extensive intellectual property portfolio.
"With the addition of these key Asian territories our Factor IX program now has broad patent coverage in major markets including the United States, Europe, China and Japan,” said Nassim Usman, Ph.D., Catalyst’s President and Chief Executive Officer.
The Company’s Factor IX clinical development program currently includes an ongoing Phase 1/2 proof-of-concept clinical trial to evaluate the subcutaneous bioavailability and clotting ability of CB 2679d. Catalyst believes that subcutaneous prophylactic therapy of CB 2979d has the potential to provide greater convenience while eliminating spontaneous bleeding in individuals with hemophilia B.
About Factor IX
CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is being evaluated in a Phase 1/2 proof-of-concept clinical trial in South Korea. Data from the first Cohort of patients (n=3) demonstrated that intravenous CB2679d is approximately 22 times more potent than intravenous BeneFIX®. Additional interim, top-line results of this open-label study are expected by the end of 2017 and complete trial results are expected to be available in early 2018. Catalyst believes that CB 2679d may allow for subcutaneous prophylactic treatment of individuals with hemophilia B.
Catalyst is a clinical-stage biopharmaceutical company focused on 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, statements relating to risks related to the Company’s ability to protect or enforce intellectual property rights related to its product candidates, Catalyst’s clinical trial timelines, including the anticipated completion of a Phase 1/2 proof-of-concept study for CB 2679d or the plans to disclose interim top-line results from the Phase 1/2 study by the end of 2017 and complete trial results by early 2018, and the potential uses and benefits of subcutaneously dosed CB 2679d. 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 trials and enrollment may be delayed and may not have satisfactory outcomes, that human trials will not replicate the results from preclinical studies or that later cohorts may not replicate results from earlier cohorts of the same trial, that subcutaneous dosing of CB 2679d may not replicate potency or longevity of intravenous dosing, that potential adverse effects may arise from the testing or use of Catalyst’s products, including the generation of antibodies, 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 SEC on August 3, 2017. Catalyst does not assume any obligation to update any forward-looking statements, except as required by law.
Fletcher Payne, CFO, Catalyst Biosciences