Eupraxia Pharmaceuticals Inc. a clinical-stage biotechnology company specializing in precision local drug delivery, today announced additional positive clinical data from its ongoing RESOLVE Phase 1b/2a trial evaluating EP-104GI for the treatment of 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. The Company's ongoing RESOLVE trial is a Phase 1b/2a, multi-center, open-label, dose-escalation study that is evaluating EP-104GI across multiple patient cohorts by assessing key clinical measurements associated with EoE, including SDI, impact on tissue health (histology) as measured by EoEHSS, and the measurement of peak eosinophil count ("PEC").

"In the RESOLVE trial, positive efficacy and safety outcomes continue to be observed," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "We believe the positive dose-response data from these first six cohorts clearly demonstrate that precise, localized delivery of EP-104GI at higher doses is leading to further improvements in both tissue health and symptom reductions. Also, no serious adverse events nor events of oral or gastrointestinal candidiasis, commonly seen in EOE patients being treated with steroids, have been observed in any of the first six Cohorts."

"We are highly encouraged by the fact that EP-104GI has demonstrated strong activity despite only being administered to varying portions of the esophagus to this point in the trial. This suggests that maximizing esophageal coverage with EP-104GI could lead to further improvements in histology and symptoms. Based on these observations, and the safety results to date, we intend to further explore the potential treatment effect of EP-104GI at higher dosing levels and over expanded esophageal coverage in the upcoming cohorts. The collective safety and efficacy data from the RESOLVE study continue to demonstrate that EP-104GI has the potential to become a new standard of care for the treatment of EoE, and we look forward to reporting the first set of nine-month data from the RESOLVE study in the second quarter."

Key Findings from the Sixth Cohort of the RESOLVE Trial

Each patient in the sixth cohort received 16 injections of 4 mg EP-104GI (total dose: 64 mg) targeting the lower three-quarters of the esophagus. The results include:

• Symptom Improvement (SDI): All three patients reported reduced symptom severity, with peak SDI score reductions of up to 5 points (71%) and an average reduction of 46% (3 points) at 12 weeks.
• Tissue Health (EoEHSS): The largest improvement in tissue health observed in any cohort to date, with peak Stage and Grade score reductions of 89% and 88%, respectively, and mean Stage and Grade score reductions of 66% and 65%.
• Peak Eosinophil Counts (PEC): Mean 94% reduction in eosinophils across a standard number of biopsy sites within the treated area. There was a mean 62% remission rate across all biopsy sites.
• Safety: Plasma fluticasone levels remained predictable and well below published levels for daily asthma treatments, with no serious adverse events reported.

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 healthcare system and the individual.

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 micro-sphere 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 hyper-localized fashion, targeting only the tissues that physicians are wanting to treat.

We believe 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 FDA-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/2a 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 endpoint and three of the four secondary endpoints. 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. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.

 

Source: prnewswire.com

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