30/07/2021

Eupraxia Prescribed drugs Inc. Announces Authorization of Scientific Trial Software for Stage 2 Trial of EP-104IAR in Osteoarthritis of the Knee

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.

About EP-104IAR

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.

About Eupraxia

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

Notice With regards to Forward-searching Statements and Facts:

This information release includes ahead-on the lookout statements and forward–looking data within the this means of Canadian securities guidelines. Often, but not always, forward–looking information can be identified by the use of words these kinds of as “options”, “is anticipated”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or versions (together with unfavorable and grammatical variations) of these types of phrases and phrases, or state that specified steps, situations or effects “may perhaps”, “could”, “would”, “might” or “will” be taken, happen or be obtained. Forward wanting statements in this push release incorporate statements pertaining to the Company’s company strategies and targets, which includes present-day and potential ideas and the Company’s capacity to move into Period 3 progress, expectations and intentions, statements pertaining to the Firm’s Stage 2 clinical trial, like the predicted timing of the details readout and the results thereof, the potential of the Corporation to execute on its business tactic, the Company obtaining ample resources, the potential of Eupraxia’s products candidates, the likely for the Firm’s technological know-how to effects the drug delivery system, the competitive positive aspects of the Firm’s engineering, the added benefits to sufferers from the Firm’s drug platforms, the translation of the Company’s technologies and expansion of its offerings into medical purposes, the Firm’s estimation of opportunity solution marketplaces and the demand and current market acceptance for solutions made by the Company. These statements and data are centered on the current expectations of Eupraxia’s management, and are primarily based on assumptions, such as but not constrained to: upcoming analysis and progress strategies for the Firm continuing significantly as at the moment envisioned industry expansion traits, including with respect to projected and true marketplace product sales the Firm’s capacity to get hold of favourable success from the Firm’s research and progress things to do, which includes scientific trials and the Firm’s skill to shield patents and proprietary rights. Although Eupraxia’s management thinks that the assumptions fundamental these statements and information are affordable, they may possibly confirm to be incorrect. The forward–looking gatherings and instances discussed in this news release may possibly not occur by certain dates or at all and could differ materially as a consequence of acknowledged and unidentified risk components and uncertainties influencing Eupraxia, like, but not minimal to: the Firm’s limited running historical past the Company’s novel technology with unsure industry acceptance if the Company breaches any of the agreements under which it licenses rights to its product or service candidates or technological innovation from third get-togethers, the Corporation could lose license legal rights that are significant to its organization the Firm’s current license agreement may not provide an adequate cure for its breach by the licensor the Firm’s technology may not be thriving for its meant use the Company’s potential technology will require regulatory acceptance, which is high-priced and the Organization may not be capable to acquire it the Business may possibly are unsuccessful to acquire regulatory approvals or only acquire approvals for limited uses or indications the Corporation entirely depends on 3rd functions to supply materials and inputs demanded for its merchandise and providers the Firm depends on external contract investigation companies to provide scientific and nonclinical study services the Firm may perhaps not be in a position to correctly execute its business enterprise system the Organization will need more financing, which may perhaps not be available any therapeutics the Enterprise develops will be subject matter to substantial, prolonged and uncertain regulatory specifications, which could adversely influence the Company’s means to obtain regulatory approval in a timely fashion, or at all the effect of the COVID-19 pandemic on the Company’s operations and other pitfalls and uncertainties explained in far more element in Eupraxia’s general public filings on SEDAR (www.sedar.com). Although Eupraxia has attempted to identify important things that could trigger true steps, events or success to differ materially from those explained in forward–looking statements and information and facts, there could be other variables that induce actions, functions or success to differ from individuals expected, estimated or supposed. No forward–looking statement or info can be certain. Other than as necessary by relevant securities guidelines, forward–looking statements and information talk only as of the day on which they are produced and Eupraxia undertakes no obligation to publicly update or revise any forward–looking statement or information, irrespective of whether as a consequence of new information, long term situations or in any other case.

Resource Eupraxia Pharmaceuticals Inc.

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