Eupraxia Pharmaceuticals Inc. announced the Company has initiated its Phase 3 development program for EP-104IAR, the Company's lead drug candidate for the treatment of osteoarthritis ("OA") of the knee, following completion of its End-of-Phase 2 meeting with the U.S. Food & Drug Administration ("the FDA"). Based on this interaction, the Company anticipates it is on track to dose the first patient in its Phase 3 program in the third quarter of 2024. The recent End-of-Phase 2 meeting with the FDA addressed non-clinical and clinical topics, including discussions on the size of the required safety database, and the main design elements of repeat dose study and the comparative bioavailability study required to satisfy requirements for the 505(b)(2) approval pathway.

Based on the detailed and informative interaction with the FDA, at this time, Eupraxia anticipates that the remaining clinical trials to support a 505(b) application for EP-104IAR will consist of: PROMENADE 1 ? A Phase 3 trial in approximately 740 knee OA patients to confirm the safety and efficacy of a single dose of EP-104IAR for six months post-dose. The Company anticipates that a subset of patients will be followed for one year .

PROMENADE 2 ? A Phase 3 trial in approximately 300 patients to evaluate the safety and durability of response after a second dose of EP-104IAR. Eupraxia anticipates that the trial will be run in parallel with PROMENADE 1 and patients will be followed for a maximum of nine months after the second injection.

A Phase 1 study carried out in approximately 30 patients comparing the pharmacokinetics of EP-104IAR and Flovent HFA. Eupraxia's lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting disease relief in multiple indications benefitting from highly localized and longer delivery of corticosteroids. The lead indication is for pain relief in knee OA.

The U.S. Centers for Disease Control and Prevention estimates knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer from knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can significantly affect quality of life.

With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. The Company believes current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for treating knee OA pain.

Currently approved corticosteroids are very effective at reducing pain for a short duration late in the disease but can expose the body to unwanted local and systemic side effects. EP-104IAR is designed to prolong the duration of pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane, part of Eupraxia's patented technology platform.

Injected into the knee, EP-104IAR is designed to diffuse the corticosteroid slowly into the knee joint providing local therapeutic concentrations for up to six months. This has the potential dual advantage of providing longer duration of pain relief with fewer systemic side effects. A robust safety and tolerability profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees by allowing simultaneous treatment of both affected joints.

EP-104IAR has also been designed to incorporate additional advantages, such as physician convenience, targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques.