Catalyst Biosciences, Inc. (NASDAQ:CBIO) recently announced that it will make an oral presentation of the Phase1/2 trial of subcutaneous (SQ) Factor IX candidate 2679d/ISU304 top-line data at the 11th Annual Congress of The European Association for Hemophilia and Allied Disorders (EAHAD). The clinical-stage biopharmaceutical company that is currently focusing on the development of novel medicines in order to address hematology indications will make the presentation at EAHAD in Madrid from Feb 7 to 9, 2018.
Catalyst especially is keenly focusing on the field of homeostasis’ including facilitating surgery in individuals suffering from hemophilia and the subcutaneous prophylaxis of hemophilia. Few weeks ago Catalyst Biosciences announced that its protocol amendment to omit single dose Cohort 4 (300 IU/kg daily-high dose), as well as move directly to multi-dose Cohort 5 at 150 IU/kg daily in the currently ongoing CB 2679d/ISU304 Phase ½ multi-dose study, has received approval from the Korean Ministry of Food and Drug Safety (MFDS).
The highly potent next-generation coagulation Factor IX (FIX) variant in individual patients with severe hemophilia B has also received approval from MFDS.
Catalyst Enrolling Patients In Final Multi-Dose Cohort
According to the chief medical officer of Catalyst, Dr. Howard Levy, by approving the given protocol amendment to accelerate the Phase ½ trial, the MFDS has agreed that the high single dose of CB 2679d considered in Cohort 4 is not needed because the current lower subcutaneous doses have been found to achieve normal Factor IX levels after the administration of multi-dose.
Levy further stated that the company is currently enrolling patients in the final multi-dose cohort and with the accelerated protocol is expecting to have multi-dose data by the first quarter of 2018. According to Levy, the data from Cohorts 1 through 3 demonstrated that the CB 2679d half-life was around five times more than intravenous wild-type FIX which was the reason for a favorable response from MFDS regarding the protocol amendment.
The company has already presented the interim data from Cohorts 1 through 3 at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition.