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Find Clinical Drug Pipeline Developments & Deals by Catalyst Biosciences
The agreement will bring to GC Biopharma 3 programs, including MarzAA (marzeptacog alfa), an engineered factor VIIa which is ready for Phase 3 clinical stage development.
F351 is a next-generation pirfenidone analog in Phase 3 clinical development for the treatment of HBV associated liver fibrosis in China and the combined company expects to file an IND in the US and commence Phase 2 studies in 2023.
Companies have signed agreement under which Vertex has acquired Catalyst’s portfolio of protease medicines that regulate complement, including CB 2782-PEG.
Under the terms of the agreement, Biogen has returned the rights for further development on CB 2782-PEG and has ended the collaboration on other potential AMD treatments.
Marzeptacog alfa (activated), or MarzAA demonstrates its potential in treating multiple rare bleeding disorders. MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding.
The objective of the study was to conduct simulations using a MarzAA-specific, population pharmacokinetic (PK) model in a large population following different dose levels of MarzAA.
The natural history of disease study will follow up and assess these patients for clinical outcomes, biomarkers of complement dysregulation as well as safety and effectiveness of their current treatments in preparation for the clinical development program of CB 4332.
This trial is being conducted in parallel with the ongoing Phase 3 registration trial evaluating MarzAA for the treatment of episodic bleeds in patients with Hemophilia A or B with inhibitors.
The patent protects nucleic acids encoding modified proteases that selectively cleave and degrade complement factor 3 (C3), including the lead candidate CB 2782-PEG, Catalyst's potential best-in-class treatment for dry AMD, currently licensed to Biogen.
The Phase 3 study a cross-over study to evaluate the efficacy and safety of MarzAA for on-demand treatment of spontaneous or traumatic bleeding episodes, in adolescents and adults with congenital Hemophilia A or B with inhibitors, compared to Standard of Care.