Medexus Pharmaceuticals Inc (CVE:MDP) (OTCQX:MEDXF) said it's on track to complete patient enrollment for its Phase 4 clinical trial investigating IXINITY to treat under 12s with hemophilia B by the second quarter of 2021, having now recruited half of the patients required.
In February this year, the pharma group announced the acquisition of the worldwide rights to IXINITY, from Aptevo Therapeutics Inc (NASDAQ: APVO).
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That was a month after the latter had started dosing patients in the Phase 4 study to evaluate the safety and efficacy of the FDA- approved drug in previously treated patients under 12 years.
The hemophilia B market in the USA alone is estimated to be worth over US$$1 billion and the pediatric segment is estimated to represent one-third of the hemophilia B population, noted Medexus.
"We are encouraged by the steady progress of our IXINITY Phase 4 pediatric clinical trial, as we have now reached the 50% enrollment target and are on track to complete enrollment by the second calendar quarter of 2021," said Khaled Mohamed, director of regulatory affairs for Medexus.
"We look forward to completing this current study, which we are hopeful will allow us to expand the product label to include the U.S. pediatric population below 12 years of age.”
Once completed, this study may support a significant expansion of the number of patients who could be be treated with IXINITY, said Medexus.
"Previously reported and pooled data from Phase 3 clinical trials demonstrated IXINITY to be safe and well tolerated in preventing and controlling bleeding episodes in previously treated children under the age of 12 with hemophilia B. We remain determined to advance our IXINITY Phase 4 pediatric clinical trial and look forward to providing further updates as we achieve key milestones," added Ken d’Entremont, the CEO of Medexus.
Medexus Pharmaceuticals is focused on the therapeutic areas of auto-immune disease, hematology and allergy.
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