VICTORIA, BC, July 19, 2021 /CNW/ – Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (TSX: EPRX), a Section 2 scientific-stage biotechnology enterprise with an revolutionary drug delivery engineering platform, these days introduced the authorization of its Clinical Demo Application (“CTA”) by the Danish Medications Company (“DKMA”). The authorization is demanded to initiate the Company’s Phase 2 clinical demo for its direct candidate EP-104IAR as a likely cure for discomfort from osteoarthritis (“OA”) of the knee.
The trial is being performed by agreement study corporation Nordic Biosciences Medical Improvement A/S (“NBCD”) and is predicted to enroll its initial individual in the 3rd quarter of 2021.
“Authorization of our CTA in Denmark is an critical action for the Company and EP-104IAR,” claimed Dr. James Helliwell, CEO of Eupraxia. “As this trial will get underway, we are also operating to broaden the opportunity of this prospect by initiating a pre-scientific analyze to support repeat dosing. Our current preclinical cartilage sparing facts, blended with the potential for repeat dosing, are significant competitive differentiators that could help industry growth chances for EP-104IAR, if authorised.”
Eupraxia’s Period 2 analyze is a placebo-managed, double-blind, randomized trial analyzing the efficacy and protection of EP-104IAR in 300 individuals with continual knee OA. Individuals will be randomized to receive both a single injection of 25 mg EP-104IAR or placebo with a key endpoint of adjust in Western Ontario and McMaster Universities Osteoarthritis Index (“WOMAC”) pain rating at week 12. Secondary endpoints contain transform in WOMAC purpose at 7 days 12 and adjust in WOMAC agony score at 7 days 24. There are added endpoints relating to good quality of life, disease point out and use of rescue medication.
NBCD has a demonstrated keep track of report in conducting OA scientific trials and will initiate the demo at various medical investigation centres in Denmark in the 3rd quarter of 2021, with affected individual recruitment continuing by way of spring 2022, and information readout envisioned in the fourth quarter of 2022.
Eupraxia has an open Investigational New Drug (“IND”) Application with the United States Food stuff and Drug Administration (“Food and drug administration”) and NBCD maintains a world operational footprint, allowing for Eupraxia to perhaps grow both equally the present-day and potential trials into the United States and other geographies as essential.
Eupraxia’s guide merchandise prospect, EP-104IAR, is built to satisfy the major unmet clinical will need and market demand for long-lasting soreness reduction for knee OA. The U.S. Centers for Ailment Control and Avoidance estimates that knee OA affects a lot more than 30 million men and women in the U.S. on your own. This consists of 14 million that put up with with knee discomfort or some form of incapacity. Knee OA is also associated with depression and loss of snooze, which can significantly have an effect on quality of daily life.
With EP-104IAR, Eupraxia hopes to adjust the way knee OA suffering is treated. Existing therapies are challenged by poor security, insufficient efficacy and/or confined duration of action. Corticosteroids are just one of only two drug courses strongly encouraged by the American Higher education of Rheumatology and the Arthritis Foundation for the treatment of knee OA ache. Currently authorised corticosteroids are extremely productive at minimizing soreness for a brief period but can expose the system to unwelcome nearby and systemic side consequences.
EP-104IAR is getting made to deliver very long-time period discomfort reduction with much less undesirable aspect consequences. It encapsulates a extremely powerful corticosteroid (fluticasone propionate) within just a microns-slim polymer membrane.
Injected into the knee, EP-104IAR is supposed to slowly but surely launch drug at therapeutic concentrations for up to six months. This has the opportunity twin benefit of providing extended-length suffering reduction with less systemic facet effects. An improved protection profile would also advantage the believed 70% of knee OA people that experience agony in both knees.
EP-104IAR has finished a Period 1 demo and is at present in Stage 2 clinical progress. A modified model of EP-104IAR is beneath development for canine and equine OA.
Eupraxia is a medical-phase biotechnology company focused on the growth of regionally sent, prolonged-release alternate options to presently accepted medication. Every single of Eupraxia’s item candidates has the prospective to deal with therapeutic regions with superior unmet professional medical want and strives to supply improved patient advantage by offering qualified, prolonged-lasting exercise with fewer facet effects.
Eupraxia’s direct product or service prospect, EP-104IAR, is at present in Period 2 enhancement for the procedure of pain because of to OA of the knee. In addition to EP-104IAR, Eupraxia is acquiring a pipeline of previously-stage long-performing formulations. Possible pipeline candidates involve a assortment of medicines for indications these as put up-surgical soreness (EP-105), and submit-surgical web-site infections (EP-201), every single built to strengthen on the action and tolerability of accredited medications. Eupraxia is also establishing a formulation of EP-104IAR for use in canine and equine OA.
For further more details about Eupraxia, you should visit the Firm’s website at: www.eupraxiapharma.com
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