Date: 2017-03-28
Type of
information: Treatment of the first patient
phase: 1-2
Announcement: treatment of the first patient
Company: Catalyst Biosciences (USA - CA)
Product: CB 2679d/ISU304
Action
mechanism:
- coagulation factor/protein. CB 2679d/ISU304 is a next-generation coagulation Factor IX variant. It has exhibited enhanced procoagulant activity, improved efficacy in inhibiting blood loss, and prolonged duration of action in bleeding and non-bleeding preclinical models compared with other Factor IX products on the market.
- Catalyst has a collaboration with ISU Abxis to advance the development of CB 2679d/ISU304 through a Phase 1/2 proof-of-concept study in individuals with severe hemophilia B. After Phase 1/2, ISU Abxis has an option for exclusive commercial rights in South Korea and a profit share on ex-South Korean commercialization. Catalyst retains full development and commercial rights for CB 2679d/ISU304 outside of South Korea.
Disease: hemophilia B
Therapeutic
area: Rare diseases - Genetic diseases - Hematological diseases
Country: Republic of Korea
Trial
details: The clinical trial will include single intravenous and subcutaneous dosing cohorts, followed by daily subcutaneous injections of CB 2679d/ISU304, Catalyst’s next-generation coagulation Factor IX variant. Currently approved hemophilia B therapies require frequent intravenous infusions where adherence and convenient access to peripheral veins is difficult, often necessitating the use of a central venous access device with the associated risks of infection and thrombosis, and do not result in sustained normalization of FIX activity.
Latest
news:
- • On June 14, 2017, Catalyst Biosciences and ISU Abxis, Catalyst’s collaborator in the development of its Factor IX variant, announced that ISU Abxis has completed dosing of the first of up to five patient cohorts in a Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B. The Companies plan to have top line data from the trial by the end of 2017.
- • On March 28, 2017, Catalyst Biosciences announced that the Korean Ministry of Food and Drug Safety (MFDS) approved the Investigational New Drug Application (IND) for CB 2679d/ISU304. Catalyst’s collaborator, ISU Abxis plans to initiate a Phase 1/2 proof-of-concept study with single and multiple subcutaneous injections in individuals with severe hemophilia B in the second quarter of 2017.
Is
general: Yes
