Eupraxia posts 24-week data in high-dose Resolve cohort

Dr. James Helliwell reports EUPRAXIA PHARMACEUTICALS REPORTS SIX-MONTH SYMPTOM DATA FROM THE HIGHEST DOSE cohort IN ITS ONGOING PHASE 1B/2A RESOLVE TRIAL IN EOSINOPHILIC ESOPHAGITIS Eupraxia Pharmaceuticals Inc. has released positive symptom data from patients in the two highest-dose cohorts from its continuing phase 1b/2a part of the Resolve trial evaluating EP-104GI for the treatment of eosinophilic esophagitis (EoE). For the first time, Eupraxia is reporting 24-week data on symptom response from the highest dose cohort in the open label, phase 1b/2a portion of the Resolve trial. The data are important because they are from one of the two doses that are being studied in the placebo-controlled phase 2b portion of the study. Patients in the highest-dose cohort (n equals three) had an average reduction of four points in their symptom scores compared with baseline (as measured by SDI, where a three-point reduction is clinical remission). Across dose cohorts 4 to 9, the decrease in symptom response is the highest at 24 weeks, compared with earlier timepoints. This underlines the value of continuous and steady steroid exposure to reduce inflammation early and fibrosis over time in EoE patients. EP-104GI continues to be well tolerated by patients receiving the drug; 31 patients have been treated in the phase 1b/2a study and over 220 patient -- months of follow-up have been reported with no serious adverse events (SAEs). There have been no cases of oropharyngeal candidiasis, a commonly reported adverse event with the oral delivery of steroids. "We are very pleased to see such a meaningful symptom response at 24 weeks in the highest dose of the phase 1b/2a portion of the Resolve study," said Dr. James A. Helliwell, chief executive officer of Eupraxia. "We believe this type of response based on a single administration procedure would represent a compellingly different option for EoE patients. Importantly, the response that we are observing across cohorts 4 to 9 has increased as patients progress through the study through to week 24. We believe this demonstrates the importance of stable, continuous long-term local steroids in tamping down signs of inflammation quickly and acting on fibrosis in the longer term. Also, as previously reported, we continue to be encouraged by the safety profile that we have observed with EP-104GI. Currently, with 31 patients dosed in the phase 1b/2a study, and over 220 months of follow-up, there have been no reported serious adverse events." Key new findings from the Resolve trial Clinical remission and symptom response Subanalyses of pooled, available Straumann Dysphagia Index (SDI) scores from dose cohorts including at least 12 injections (cohorts 4 to 9) indicated that: At 12 weeks, 59 per cent (13/22) of patients achieved clinical remission (1); At 24 weeks, 76 per cent (13/17) of patients maintained clinical remission (1); At 52 weeks, 67 per cent (six/nine) of patients maintained clinical remission (1). Furthermore, at 24 weeks, dose cohort 9 (20 by eight milligrams; n equals three) showed a mean reduction of 4.0 points in SDI score where a reduction of 3.0 points is considered clinical remission. Addition of new six-milligram/site cohort (cohort 8b) During the dose-escalation part of the study, doses of six mg/site were found to cause clogging in the 21-gauge catheters used in earlier cohorts. The jump from four mg/site to 6mg/site represented a 50-per-cent increase in particle concentration which disrupted fluid flow. Larger 19-gauge catheters (with five times less internal resistance) were subsequently adopted, and the increased particle density was easily accommodated. These catheters were then used for an additional four patients at the six mg/site dose (forming a new cohort called cohort 8b), for cohort 9 (eight mg/site) and are currently being used in the phase 2b portion of the Resolve trial. Comparison of histologic and symptom data from cohort 8b versus cohort 8 at 12 weeks demonstrated meaningfully improved outcomes due to improved drug delivery to the tissues associated with the appropriate catheter. The following results were seen: EoEHSS stage and grade reductions: cohort 8b achieved average reductions of negative 0.38 and negative 0.38, respectively, compared with negative 0.08 and negative 0.12 for cohort 8; SDI: cohort 8b achieved an average reduction of negative 3.8, compared with negative 0.3 for cohort 8; Peak eosinophil reduction: cohort 8b achieved an average reduction of 65.2 per cent, compared with 30.6 per cent for cohort 8; Cohort 8b has re-established the dose-response relationship in EoEHSS across cohorts, which had not been observed in cohort 8. Safety and tolerability Over 220 patient-months of follow-up have been reported across 31 patients in all cohorts; No SAEs have been reported to date; No cases of oropharyngeal candidiasis, a commonly reported adverse event associated with the use of swallowed steroids, have been reported to date; One patient in cohort 8 was lost to follow-up at the six-month visit; No cases of adrenal insufficiency or glucose derangement, including in the single patient with diabetes; EP-104GI has been well tolerated at all dose levels, including the highest dose of eight mg/site. An updated summary of the above and previously announced clinical trial results are posted in the investor section of the Eupraxia Pharmaceuticals website. About the Resolve trial The phase 1b/2a part of the Resolve trial, is a multicentre, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics and efficacy of EP-104GI in adults with histologically confirmed active EoE. The treatment is administered as a single dose via four to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Participants were followed for up to 24 weeks in cohorts 1 to 4 (four by one mg, eight by one mg, eight by 2.5 mg and 12 by 2.5 mg) or 52 weeks in cohorts 5 to 9 (12 by four mg, 16 by four mg, 20 by 4 mg, 20 by 6 mg and 20 by 8 mg). Eupraxia plans to disclose additional data from the open-label phase 1b/2a part of the Resolve trial in the coming months. The phase 2b part of Resolve trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120 mg (20 by six mg) and 160 mg (20 by eight mg) doses. The top-line data from the phase 2b part of the Resolve trial is expected in Q3 2026. Notes Clinical remission is defined as a reduction of at least three points on the SDI scale. Achieving clinical remission is a positive outcome for the Resolve trial. SDI is a patient-reported outcome score that uses a seven-day recall measuring dysphagia (trouble swallowing) severity and frequency. A reduction in SDI is a positive outcome for the Resolve trial. About Eosinophilic Esophagitis (EoE) EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the health care system and the individual. About Eupraxia Pharmaceuticals Inc. Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere, a proprietary, polymer-based microsphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyperlocalized fashion, targeting only the tissues that physicians are wanting to treat. The company believes the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the Diffusphere technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's Diffusphere technology platform has the potential to augment and transform existing Food and Drug Administration-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas. Eupraxia's EP-104GI is currently in a phase 1b/2 trial, the Resolve trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also completed a phase 2b clinical trial (Springboard) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary end point and three of the four secondary end points. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. We seek Safe Harbor.