Catalyst Biosciences Inc (NASDAQ:CBIO) recently announced the initiation and open enrollment of the Phase 2/3 program’s Phase 2 part of marzeptacog alfa (activated) (MarzAA), a Factor VIIa potent therapy administered subcutaneously. The clinical-stage biopharmaceutical company is developing the therapy for prophylaxis in hemophilia A or B with inhibitors.
The president and chief executive officer of Catalyst, Nassim Usman, Ph.D. said that as of now no approved subcutaneous therapies exist for individuals with hemophilia B with inhibitors and the recently approved subcutaneous treatment for hemophilia A with inhibitors still has safety issues. Usman said that along with the Phase 2 MarzAA trial, the company is simultaneously carrying out two clinical studies with subcutaneous patients with hemophilia.
According to Usman, Catalyst is now one step closer to the potential of providing convenient as well as safe options for treatment. The company is using high potency replacement coagulation factors for coagulation restoration. Catalyst is currently focused on developing novel medicines especially to address conditions with hematology indications.
MarzAA Is Safe For Individuals With Severe Hemophilia
The Phase 2 open-label, subcutaneous trial for efficacy in individuals with hemophilia A or B with inhibitors will determine how well MarzAA can help in eliminating or minimizing episodes of spontaneous bleeding. The Phase 1 data in 25 individuals suffering from severe hemophilia without or with inhibitors revealed that MarzAA has excellent safety and tolerability.
The U.S Food and Drug Administration (FDA) has already granted MarzAA with orphan drug designation for routine prophylaxis to prevent episodes of bleeding in individuals with hemophilia A or B with inhibitors.
At the stock market front, Catalyst witnessed a small rise in the rate with its stock increasing by 4.56% reaching $14.88 in the trade of 92,615 shares. The share value of the company has declined 80.67% since last few days and the downtrend continues. Currently, Catalyst has a market cap of $86.51 million.
Apart from MarzAA, Catalyst is also engaged in the development of a Factor IX drug, CB 2679d/ISU304. The preclinical studies for this drug for the prophylactic treatment of individuals have already been completed.