CB 2679d demonstrated a 22-fold greater potency over BeneFIX and a longer mean residence time

SOUTH SAN FRANCISCO, Calif., Nov. 01, 2017 (GLOBE NEWSWIRE) — Catalyst Biosciences, Inc. (CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced an oral presentation, entitled “Phase I/2 Trial of Subcutaneously Administered Factor IX Variant CB 2679d/ISU304: Pharmacokinetics and Activity” authored by Chur Woo You, M.D., Ph.D., Eulji University Hospital, et al., will be presented by Dr. Howard Levy, chief medical officer of Catalyst at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition being held Dec. 9-12, 2017 in Atlanta.

Dr. Levy will present interim pharmacokinetic and pharmacodynamic results from intravenous and subcutaneous dosing of several subjects from ISU Abxis Co., Ltd. (086890.KQ), and Catalyst’s ongoing Phase 1/2 trial of drug candidate CB 2679d/ISU304, a coagulation Factor IX (FIX) variant being developed for the subcutaneous treatment of hemophilia B. Results from the first cohort of patients in the trial demonstrated that CB 2679d has 22-fold greater potency than BeneFIX, the most commonly prescribed FIX treatment for hemophilia B, after a single intravenous dose. The data to date support the potential of achieving normal or mild hemophilia FIX levels in individuals with hemophilia B with repeated daily subcutaneous dosing.

“All current FIX treatments require intravenous administration and do not provide sustained normal or even mild FIX trough levels,” said Dr. Levy. “However, due to its subcutaneous administration route and potential to normalize FIX levels, CB 2679d is an exciting potential new prophylactic treatment option for individuals, especially children, with hemophilia B. We look forward to announcing our top-line results by Q1 of 2018.”

Details for the oral presentation are as follows:

Presentation Title:      Phase 1/2 Trial of Subcutaneously Administered Factor IX Variant CB 2679d/ISU304: Pharmacokinetics and Activity
Presenter: Howard Levy, M.B.B.Ch., Ph.D., M.M.M.
Session Title: 322. Disorders of Coagulation or Fibrinolysis: Novel Therapies and Clinical Trials in Bleeding Disorders
Date/Time: Saturday, Dec. 9, 2017 at 10:15 a.m. EST
Room: Georgia World Congress Center, Bldg B, Lvl 2, B207-B208

About Catalyst Biosciences
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.catbio.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements 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 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 have results from this study between the end of 2017 and the first quarter of 2018, the potential uses and benefits of subcutaneously dosed CB 2679d, and the Company’s belief regarding sufficiency of its existing capital resources to meet its projected operating requirements for at least the next 12 months. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the 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 clinical trials and studies may be delayed and may not have satisfactory outcomes, that potential adverse effects may arise from the testing or use of Catalyst’s products, the risk that costs required to develop or manufacture Catalyst’s products will be higher than anticipated, competition and other factors that affect our ability to successfully develop and commercialize our product candidates, and other risks described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. Catalyst does not assume any obligation to update any forward-looking statements, except as required by law.

Contacts:

Investors:
Fletcher Payne, CFO
Catalyst Biosciences, Inc.
1.650.871.0761
investors@catbio.com

Media
Josephine Belluardo, Ph.D.
LifeSci Public Relations
1.646.751.4361
jo@lifescipublicrelations.com