Medexus Pharmaceuticals (MDP.T) announced today that it has completed enrollment in its Phase 4 clinical trial of IXINITY®, targeting label expansion for pediatric hemophilia B.
We are hopeful that this study will allow us to expand the product label to include the U.S. pediatric population below 12 years of age. We believe this could prove to be a vital, additional therapy option to the pediatric population and look forward to submitting the full data set to FDA by end of 2022,” stated Khaled Mohamed, Director of Regulatory Affairs for Medexus.
In a Phase 4 clinical trial, drugs that have already been approved by the FDA are observed over a long period of time. This is commonly referred to as a post-marketing surveillance trial or drug monitoring trial to assure long-term safety and efficacy of a drug. In the case of Medexus, the Company’s IXINITY® is undergoing a Phase 4 clinical trial in an attempt to expand the Company’s IXINITY® product label to include the U.S. pediatric population below 12 years of age. Keep in mind, according to the World Federation of Hemophilia ‘Report on Annual Global Survey 2017,’ approximately 1 in 3 patients treated for hemophilia B in the U.S. are 12 years of age or younger.
Currently, IXINITY® is an FDA approved intravenous recombinant factor IX therapeutic for use in patients 12 years or older with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of clotting factor IX. In mild cases of hemophilia B, individuals may experience bruising and bleeding after surgery, dental procedures, injury, or trauma. In more serious cases of hemophilia B, individuals are at risk of frequent, spontaneous bleeding episodes. With this in mind, clotting factors are specialized blood proteins needed for blood clotting, the process by which blood seals a wound to stop bleeding and promote healing. At this time, the fundamental treatment of hemophilia B involves replacing factor IX to achieve adequate blood clotting.
“The hemophilia B market in the U.S. alone is estimated to be in excess of USD $1 billion1. A label expansion inclusive of the pediatric market represents a significant market opportunity for IXINITY®. 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 treated children under the age of 12 with hemophilia B. If approved, we expect to be well positioned to commercialize quickly with the infrastructure we already have in place for the adult market. Additionally, we expect our research and development expenses will come down once the final dose has been https://e4njohordzs.exactdn.com/wp-content/uploads/2021/10/tnw8sVO3j-2.pngistered,” commented Ken d’Entremont, Chief Executive Officer of Medexus.
According to Medexus’ latest press release, the Company has now enrolled its last patient in this Phase 4 clinical trial, which is expected to be completed in June 2022. Upon completion, Medexus believes this study may support the expansion of the indicated patient population for IXINITY®. Looking forward, Medexus will continue to pursue out-license partners for IXINITY® in markets outside of Canada and the U.S. Additionally, the Medexus is pursuing a New Drug Application (NDA) for treosulfan, which the Company hopes to commercialize in U.S. More details regarding Medexus’ treosulfan and financial can be found here.
Medexus’ share price opened at $4.35, up from a previous close of $4.20. The Company’s shares are down -1.19% and are currently trading at $4.15 as of 12:29PM ET.
