Date: 2017-02-01
Type of
information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the European Association of Haemophilia and Allied Disorders (EAHAD) 10TH Annual Congress
Company: Catalyst Biosciences (USA - CA)
Product: marzeptacog alfa
Action
mechanism: coagulation factor/protein
Disease: hemophilia A
Therapeutic
area: Rare diseases - Genetic diseases - Hematological diseases
Country:
Trial
details:
Latest
news:
- • On February 1, 2017, Catalyst Biosciences announced positive preclinical results in well-validated models of hemophilia A with marzeptacog alfa (activated), a next-generation Factor VIIa. The results highlight the attractive pharmacodynamics and pharmacokinetic profiles of both coagulation factors based on bioavailability, potency, time to maximal concentration, and half-life that should allow for subcutaneous (SQ) dosing in individuals with hemophilia. Catalyst plans to initiate a SQ efficacy trial of marzeptacog alfa (activated) in individuals with hemophilia B in 2017.
- The results, being presented in poster sessions at the European Association of Haemophilia and Allied Disorders (EAHAD) 10TH Annual Congress in Paris, France from February 1 to 3, 2017, are summarized below:
- Pharmacokinetics and Pharmacodynamics Of Daily Subcutaneously Administered Marzeptacog Alfa (Activated) In Hemophilia Dogs (Poster abstract #P076) Howard Levy, Timothy Nichols, Martin Lee, Elizabeth Merricks, Robin Raymer, and Andrew Hetherington. The authors tested subcutaneous doses of marzeptacog alfa (activated) in hemophilia A dogs. The following conclusions were made:
- - Bioavailability of subcutaneous injection was 44% and half-life was 50-136 hours;
- Daily subcutaneous dosing achieved steady-state levels of coagulation factor sufficient to correct the coagulation abnormality when compared with published data in hemophilic dogs that received FVIIa gene therapy and had no spontaneous bleeding for more than one year;
- - and The increased potency of marzeptacog alfa (activated) and pharmacokinetic results support the initiation of a subcutaneous dosing efficacy study in individuals with hemophilia B with inhibitors.
Is
general: Yes
