SOUTH SAN FRANCISCO, Calif. – Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced the screening of the first patient in its CFI-deficiency study in the CB 4332 program, its wholly-owned, first-in-class, enhanced Complement Factor I (CFI), intended for prophylactic subcutaneous (SQ) administration in individuals with CFI deficiency.
“The findings from the CFI deficiency screening and natural history of disease studies will be instrumental in identifying patients for the Phase 1/2 trial of CB 4332, planned for mid-year 2022,” said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. “Following the disease manifestations and biomarkers of this complement disorder will be important in unlocking the full therapeutic potential of CB 4332.”
The ConFIrm screening study will measure CFI levels and activity in patients who have diseases related to a CFI deficiency and who may potentially benefit from CB 4332 treatment. The ConFIdence natural history of disease study will follow these CFI-deficient subjects, who often present with repetitive bacterial infections, immune-related diseases, and/or glomerulopathies, for clinical biomarkers and safety of current treatments. The findings from these studies will identify opportunities to potentially develop CB 4332 for treatment in multiple indications.
Catalyst’s complement portfolio is led by the development candidates CB 4332 and CB 2782-PEG, originating from the company’s internal discovery platform, which has generated a rich pipeline of leads. CB 4332 is an engineered CFI protease with the potential to address multiple complement related disorders. CB 2782-PEG is designed as a long-acting anti-C3 protease in preclinical development for the treatment of dry AMD that Catalyst has licensed to Biogen. Catalyst has several engineered protease programs in discovery or early non-clinical development. These programs all target diseases caused by deficient regulation of the complement system.
About Catalyst Biosciences, the Protease Medicines company
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency and proteases from our ProTUNE™ C3b-C4b degrader and ImmunoTUNE™ C3a-C5a degrader platforms designed to target specific disorders of the complement or inflammatory pathways as well as other complement programs in development.
Catalyst Biosciences, Inc.