Prolor Biotech has announced positive top-line preclinical data from a comparative study of its longer-acting version of the hemophilia drug Factor VIIa (Factor VIIa-CTP) in hemophilic mice.
The preclinical trial was intended to determine an increase in survival rates, thrombin levels and in vivo recovery of Factor VIIa-CTP compared to commercially available recombinant Factor VIIa.
Researchers used a pharmacokinetic parameter, in vivo recovery, to compare actual clotting activity post-dosing to anticipated clotting activity.
The study reported that hemophilic mice receiving Prolor’s Factor VIIa-CTP demonstrated a superior survival rate over a longer time period following a bleeding challenge, superior and longer-lasting generation of thrombin, and higher in vivo recovery.
"The results of our second Factor VIIa-CTP preclinical study are consistent with the results we obtained from the previous study, and we believe they are very promising," said Prolor president Shai Novik.
"With these positive results, we now have what we believe could be a highly competitive coagulation factor that could potentially become a leader in the hemophilia market."
In an earlier comparative study, Factor VIIa-CTP showed positive results while demonstrating an increase in half-life and clotting activity when compared to commercially available Factor VIIa.
Prolor CEO Dr Abraham Havron said: "The encouraging results seen in our preclinical hemophilia studies suggest that Factor VIIa-CTP may be able to offer an improved therapeutic option for hemophiliacs by reducing the frequency of injections, controlling bleeding more effectively and significantly improving their quality of life."
Dr Havron added: "The fact that our CTP technology has now demonstrated its efficacy in enhancing the longevity of Factor VIIa and Factor IX, which are both enzymes, is another confirmation of the ability of this technology to prolong the biological activity of a variety of therapeutic proteins belonging to different functional families."
Currently, the company is developing a long-acting version of human growth hormone, long-acting versions of Factor VIIa and Factor IX for hemophilia and a GLP-1/Glucagon dual receptor agonist peptide for diabetes and obesity, and agents for atherosclerosis and rheumatoid arthritis.