Eupraxia releases first set of Resolve clinical results

Dr. James Helliwell reports FIRST SET OF 1-YEAR CLINICAL RESULTS FROM RESOLVE TRIAL IN EOSINOPHILIC ESOPHAGITIS (EOE), DURABLE AND SUSTAINED SYMPTOM & TISSUE RESPONSES AFTER DOSING WITH EP-104GI Eupraxia Pharmaceuticals Inc. has released additional positive clinical data from its continuing phase 1b/2a Resolve trial evaluating EP-104GI for the treatment of eosinophilic esophagitis, including the first clinical data measured 52 weeks after patients were treated with EP-104GI. "We believe the prolonged duration of symptom response that we are seeing with EP-104GI is truly a unique clinical result and will potentially provide a once-a-year therapy to patients with EoE, and, over all, we continue to see that the more drug we deliver to the tissues, the better the results," said Dr. James A. Helliwell, chief executive officer of Eupraxia. "Independent market research has shown that the majority of patients with EoE undergo a routine endoscopy at least once a year to monitor the progress of their disease, which is also consistent with national guidelines. Based on this, leading KOLs in EoE see a potential treatment regimen where EP-104GI is administered during this routine annual procedure, in contrast to current standards of care which are inconvenient and involve swallowing oral steroids daily or injecting themselves weekly with a biologic. As a result, we believe EP-104GI has the potential to significantly enhance the current standard of care for patients with EoE. We look forward to reporting additional 12-month data from a larger patient set later this year." Key findings from the four-milligram dose groups in the phase 1b/2a Resolve trial: Symptoms: Patients treated with four mg per injection of EP-104GI had meaningful levels of clinical remission as measured by Straumann Dysphagia Index at week 12 (56 per cent, n equals nine), week 24 (78 per cent, n equals nine), week 36 (67 per cent, n equals six) and week 52 (67 per cent, n equals three). Tissue health: Patients treated with four mg per injection (n equals six) of EP-104GI demonstrated mean improvements in EoEHSS of 47 per cent in grade (severity) and 44 per cent in stage (extent) at week 36, continuing the trend of durable improvements in tissue health. Across dose groups, there is a significant correlation between pharmacokinetics and changes in tissue health. Pharmacokinetics: Plasma levels of fluticasone in patients treated with four mg per injection of EP-104GI remained level and predictable out to 52 weeks. This is well below the levels typically observed with daily asthma inhalers. There have been no SAEs or incidence of either oral or gastrointestinal candidiasis reported to date. An updated summary of the above and previously announced clinical trial results are posted in the investor section of the Eupraxia Pharmaceuticals website. 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 recently 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.