Pfizer Announce Positive Preliminary Phase III Clinical Results
Pfizer yesterday announced positive results from their phase III clinical trial comparing prophylaxis regimen of BeneFIX Coagulation Factor IX (Recombinant) 100 IU/kg once-weekly, with on-demand treatment for moderately severe to severe hemophilia B.
Top-line results showed that the clinical trial met its primary endpoint, with a statistically noteworthy reduction in the annualised bleeding rate in comparison to on-demand treatment of the drug.
Results from the clinical study demonstrated a median annualised bleeding rate of just 2.0 for the prophylaxis regimen of the drug, a decrease of 94% in comparison to a median annualised bleeding rate of 33.6 for BeneFIX on-demand.
The reduction in annualised bleeding rate applied to both spontaneous and traumatic bleeding, with a medium spontaneous annualised bleeding rate of 1.0, compared to 22.4, and a medium traumatic annualised bleeding rate of 1.0, compared to 4.1.
Secondary endpoints were also met for the clinical study, with none of the 1,254 prophylaxis infusions being associated with a less than expected therapeutic effect occurrence, defined as a spontaneous bleed within 48 hours of a prophylaxis infusion.
Steven Romano, M.D., senior vice president and Medicines Development Group Head, Global Innovative Pharmaceuticals at Pfizer, commented that the “results are important because they add to the growing body of clinical evidence showing that prophylaxis treatment has the potential to reduce the number of bleeds in a year, the most critical factor in hemophilia management.”
Full results from the survey will be presented at upcoming medical congresses and submitted for publication in a peer-reviewed journal.