EUPRAXIA PHARMACEUTICALS INC.
For the period ended Dec 31, 2024. Filed Mar 20, 2025.
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The yearly report of certain Canadian companies, filed under a joint US and Canadian system. It is the main yearly account these companies give US investors, largely as filed in Canada.
FY2024 · Filed Mar 20, 2025
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Contents
EX-99.1 · Overview of the Company
Overview of the Company
We are a clinical-stage biotechnology company seeking to leverage our proprietary DiffuSphere™ technology to optimize drug delivery for applications with significant unmet medical need. Each of our product candidates is designed to improve patient benefit by providing more prolonged activity than currently available treatments, combined with an improved pharmacokinetics (“PK”) and related safety profile and precisely targeted local delivery. We believe a product with this profile could offer the dual potential of providing long-lasting treatment while minimizing tolerability complications in target andnon-target tissues. Our strategy is to develop a portfolio of product candidates based on this delivery technology.
We currently have two distinct clinical development programs, one targeting EoE and the second targeting chronic OA pain in the knee. Both programs are broadly based upon the same active pharmaceutical ingredient (“API”), fluticasone propionate. The injectable drug is dispensed together with a “vehicle” diluent specifically designed for the target delivery modality andco-administered with the API. For our ongoing clinical studies, we are using the same underlying API and extended-release formulation. In the future, we anticipate that therapeutic targets will be differentiated by dosing levels, vehicle and delivery methods and will be distinct product candidates. The product candidate that is being developed specifically for submucosal injections in the GI tract with an initial indication of EoE is referred to as EP-104GI, and the product candidate that is being developed for intra-articular (“IA”) injections with an initial indication of knee OA is referred to as EP-104IAR. EP-104 is intended to refer to the extended-release fluticasone propionate encapsulated with the DiffuSphere™ technology, which is used in the formulation of both EP-104GI and EP-104IAR.
We are currently conducting a Phase 1b/2a clinical trial with EP-104GI in Canada, the Netherlands, Australia and New Zealand. We also receivedpre-IND feedback from the FDA on December 3, 2024, to clarify early phase program requirements for conducting studies in the US. We intend to continue development of EP-104GI through the ongoing clinical trial and any subsequent trials required by the FDA to obtain commercial approval. We intend to evaluate the possibility of identifying a corporate partner to help with the development of EP-104GI.
We have successfully completed a Phase 2b clinical trial with EP-104IAR in knee OA, and in January 2024, we held a meeting with the FDA to determine the late-phase program requirements for an NDA submission and potential approval in the United States. We reached an agreement with the FDA on the clinical andnon-clinical programs required to achieve market authorization. We believe that the future success of the product candidate will be dependent on late phase development and commercialization expertise and will require significant resources. We are currently evaluating funding alternatives for the continued development of EP-104IAR, including potential partnership opportunities and intend to modulate investment levels pending the outcomes. We are undertaking certain preclinical and manufacturing activities as well as Phase 3 planning and preparation related to EP-104IAR to ensure continuity of the project, but we intend to wait until we have funding needs addressed before committing to additional significant spend for this program. We intend to use our capital resources previously identified for EP-104IAR development to continue development of EP-104GI.
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