Eupraxia Prescription drugs Initiates Part 2 Research in Eosinophilic Esophagitis

Eupraxia Prescription drugs Initiates Part 2 Research in Eosinophilic Esophagitis

-Represents second Part 2 program for EP-104IAR, with preliminary knowledge readout anticipated in H1, 2023-

VICTORIA, BC, Oct. 12, 2022 /CNW/ – Eupraxia Prescription drugs Inc. (“Eupraxia” or the “Firm”) (TSX: EPRX), a Part 2 clinical-stage biotechnology firm with an progressive drug supply know-how platform, right this moment introduced the initiation of a Part 2 trial of EP-104IAR in grownup sufferers with eosinophilic esophagitis (EoE), a uncommon illness that restricts the flexibility to swallow meals and drastically impacts high quality of life.

“EP-104IAR is designed to exactly ship therapeutic ranges of injected fluticasone propionate over an prolonged period, which can assist overcome a number of the limitations of conventional oral steroids and supply longer and extra secure illness remission and an improved high quality of life for sufferers with EoE,” stated Dr. James Helliwell, CEO of Eupraxia.  “On that foundation, we’re initiating a Part 2, open-label scientific examine in grownup sufferers with knowledge from the trial anticipated to start studying out within the first half of 2023.”

The Firm believes its drug supply know-how platform has the potential to be efficient in EoE based mostly on the confirmed efficacy of oral rapid launch fluticasone propionate on this indication, and the rising library of knowledge supporting the worth of extended-release steroids in quite a lot of indications. The Firm’s know-how is underpinned by a novel polymer membrane designed to launch drug at a pre-defined fee, which might end in an efficient, sustained therapy for EoE, bettering affected person outcomes.

Eupraxia has obtained regulatory clearance in Canada and the Netherlands, with responses pending from further jurisdictions. The Firm believes that this growth of its clinical-stage pipeline represents the chance to additional reveal the worth of its platform throughout a number of indications. Eupraxia is constant to pursue further drug candidates and therapeutic targets, with a selected focus in oncology.

About EoE

EoE is a power, immune mediated situation of the esophagus that causes irritation, structural harm and dysfunction. It’s characterised as an “orphan illness” – a uncommon situation that impacts fewer than 200,000 individuals in america and/or 5 in 10,000 Europeans, and for which exists important unmet medical want.

Present EoE therapy choices (together with food regimen modifications, medication comparable to proton pump inhibitors designed to assist block acid build-up, and topical steroids which might be swallowed to assist cut back swelling and irritation, and surgical dilation) typically present poor or solely non permanent management over the situation. Oral administration of steroids, together with fluticasone propionate, can present short-term aid, however extended use of those formulations, which are sometimes prescribed off-label, results in different circumstances, comparable to candidiasis (thrush) within the mouth and esophagus, and finally poor affected person compliance and illness management. In distinction, EP-104IAR poses the chance to inject long-acting fluticasone propionate straight into the affected tissues, with the potential for prolonged period of impact, optimized drug kinetics and an improved security profile.

Medical Technique

EP-104IAR is presently being evaluated in a multi-centre European Part 2 examine centered on sufferers with osteoarthritis of the knee. This program consists of important and on-going pre-clinical knowledge on EP-104IAR, permitting the EoE Part 2 examine to begin instantly in sufferers. The EoE examine will assess the protection, tolerability and potential efficacy of endoscopically focused injections of fluticasone propionate into affected areas of the esophagus. The Part 2 trial in EoE will start with a low dose to evaluate to pharmacokinetics of the supply methodology. Because the trial progresses, escalating doses could also be given to optimize affected person outcomes and period of the therapy. The examine will probably be carried out in a number of jurisdictions, together with Canada and the Netherlands.

Eupraxia intends to pursue orphan drug standing and another mechanisms that might speed up scientific testing and supreme regulatory submission for EoE.

About EP-104IAR

Eupraxia’s lead product candidate, EP-104IAR, is designed to fulfill the numerous unmet medical want and market demand for long-lasting illness aid in a number of indications benefitting from extremely localized and longer supply of corticosteroids. The lead indication is for ache aid in knee OA. The U.S. Facilities for Illness Management and Prevention estimates that knee OA impacts greater than 30 million individuals within the U.S. alone. This consists of 14 million that undergo with knee ache or some type of incapacity. Knee OA can also be related to despair and lack of sleep, which might drastically have an effect on high quality of life.

With EP-104IAR, Eupraxia hopes to alter the way in which knee OA ache is handled. Present therapies are challenged by poor security, insufficient efficacy and/or restricted period of exercise. Corticosteroids are certainly one of solely two drug courses strongly really useful by the American Faculty of Rheumatology and the Arthritis Basis for the therapy of knee OA ache. At present accredited corticosteroids are very efficient at decreasing ache for a brief period late within the illness however can expose the physique to undesirable native and systemic negative effects.

EP-104IAR endeavours to offer long-term ache aid with fewer undesirable negative effects. It encapsulates a extremely potent corticosteroid (fluticasone propionate) inside a microns-thin polymer membrane, a part of Eupraxia’s patented know-how platform.

Injected into the knee, EP-104IAR is meant to diffuse drug slowly into the knee joint offering therapeutic concentrations for as much as six months. This has the potential twin benefit of offering long-duration ache aid with fewer systemic negative effects. An enhanced security profile would additionally profit the estimated 70% of knee OA sufferers that have ache in each knees by permitting simultaneous therapy of each affected joints.

In distinction to rapid launch steroids, a non-clinical examine of EP-104IAR suggests a cartilage sparing impact, which might present a safer therapy different for these with power OA ache. The product has additionally been designed with doctor comfort in thoughts – concentrating on an extended shelf life, no refrigeration and straightforward integration into present supply methods.

The potential benefits of EP-104IAR are central to the growth into EoE and different indications. EoE is a localized inflammatory illness of the esophagus that has relied totally on swallowing steroids (typically off-label compounded variations) to manage illness signs. Eupraxia hopes {that a} localized administration of an extended-release steroid will supply sufferers an efficient therapy choice that lasts for months as a substitute of hours.

About Eupraxia Prescription drugs Inc.

Eupraxia is a clinical-stage biotechnology firm centered on the event of domestically delivered, extended-release alternate options to presently accredited medication. Every of Eupraxia’s product candidates has the potential to deal with therapeutic areas with excessive unmet medical want and strives to offer improved affected person profit by delivering focused, long-lasting exercise with fewer negative effects.

Eupraxia’s lead product candidate, EP-104IAR, is presently in Part 2 growth for the therapy of ache attributable to OA of the knee. The EP-104IAR platform is increasing into gastrointestinal illness with the launch of a program to deal with EoE. Along with EP-104IAR, Eupraxia is creating a pipeline of earlier-stage long-acting formulations. Potential pipeline candidates embrace a spread of medication for indications comparable to postsurgical ache (EP-105), and post-surgical web site infections (EP-201), every designed to enhance on the exercise and tolerability of accredited medication. For additional particulars about Eupraxia, please go to the Firm’s web site at:

Discover Concerning Ahead-looking Statements and Data

This information launch consists of forward-looking statements and ahead–trying info throughout the which means of Canadian securities legal guidelines. Usually, however not all the time, ahead–trying info could be recognized by means of phrases comparable to “plans”, “is anticipated”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes”, “potential” or variations (together with unfavorable and grammatical variations) of such phrases and phrases, or state that sure actions, occasions or outcomes “could”, “might”, “would”, “may” or “will” be taken, happen or be achieved. Ahead trying statements on this press launch embrace statements relating to the Part 2 trial of EP-104IAR in sufferers with EoE, together with the anticipated consequence of the Part 2 trial, the anticipated timing of knowledge from the Part 2 trial and the receipt of regulatory clearance from further jurisdictions; the potential and potential advantages of EP-104IAR; the Firm’s enterprise methods and targets, together with present and future plans and alternatives, expectations and intentions; statements relating to the Firm’s Part 2 scientific trials; the flexibility of the Firm to execute on its enterprise technique; the Firm having enough assets, together with anticipated funding from its present money runway;  the potential of Eupraxia’s product candidates; the Firm’s expectations relating to its product designs, together with with respect to focused shelf life, storage and ease of integration; the outcomes gathered from research of Eupraxia’s product candidates; the potential for the Firm’s know-how to influence the drug supply course of; the aggressive benefits of the Firm’s know-how; the advantages to sufferers from the Firm’s drug platforms; the interpretation of the Firm’s applied sciences and growth of its choices into scientific functions; the Firm’s estimation of potential product markets; and the demand and market acceptance for merchandise developed by the Firm. Such statements and data are based mostly on the present expectations of Eupraxia’s administration, and are based mostly on assumptions, together with however not restricted to: future analysis and growth plans for the Firm continuing considerably as presently envisioned; trade development traits, together with with respect to projected and precise trade gross sales; the Firm’s capability to acquire constructive outcomes from the Firm’s analysis and growth actions, together with scientific trials; and the Firm’s capability to guard patents and proprietary rights. Though Eupraxia’s administration believes that the assumptions underlying these statements and data are cheap, they could show to be incorrect. The ahead–trying occasions and circumstances mentioned on this information launch could not happen by sure dates or in any respect and will differ materially because of recognized and unknown danger components and uncertainties affecting Eupraxia, together with, however not restricted to: the Firm’s restricted working historical past; the Firm’s novel know-how with unsure market acceptance; if the Firm breaches any of the agreements beneath which it licenses rights to its product candidates or know-how from third events, the Firm might lose license rights which might be essential to its enterprise; the Firm’s present license settlement could not present an sufficient treatment for its breach by the licensor; the Firm’s know-how will not be profitable for its meant use; the Firm’s future know-how would require regulatory approval, which is dear and the Firm could not be capable to receive it; the Firm could fail to acquire regulatory approvals or solely receive approvals for restricted makes use of or indications; the Firm utterly depends on third events to offer provides and inputs required for its services; the Firm depends on exterior contract analysis organizations to offer scientific and non-clinical analysis companies; the Firm could not be capable to efficiently execute its enterprise technique; the Firm would require further financing, which will not be obtainable; any therapeutics the Firm develops will probably be topic to intensive, prolonged and unsure regulatory necessities, which might adversely have an effect on the Firm’s capability to acquire regulatory approval in a well timed method, or in any respect; the influence of the COVID-19 pandemic on the Firm’s operations; and different dangers and uncertainties described in additional element in Eupraxia’s public filings on SEDAR ( Though Eupraxia has tried to determine essential components that might trigger precise actions, occasions or outcomes to vary materially from these described in ahead–trying statements and data, there could also be different components that trigger actions, occasions or outcomes to vary from these anticipated, estimated or meant. No ahead–trying assertion or info could be assured. Besides as required by relevant securities legal guidelines, ahead–trying statements and data converse solely as of the date on which they’re made and Eupraxia undertakes no obligation to publicly replace or revise any ahead–trying assertion or info, whether or not because of new info, future occasions or in any other case.

SOURCE Eupraxia Prescription drugs Inc.

Eupraxia Prescription drugs Initiates Part 2 Research in Eosinophilic Esophagitis


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