Eupraxia Pharmaceuticals has announced encouraging findings from the Phase 1b/2a segment of its ongoing RESOLVE clinical investigation, focusing on EP-104GI for individuals afflicted with eosinophilic esophagitis (EoE). The reported data, encompassing 12-week and 36-week observations, reveal substantial and persistent restoration of esophageal tissue health, alongside a robust safety record. This breakthrough offers new hope for patients battling this chronic inflammatory condition.
Eupraxia's EP-104GI demonstrates significant promise in treating eosinophilic esophagitis, a chronic inflammatory disorder of the esophagus. The recent data from the RESOLVE trial highlight sustained tissue healing and high rates of clinical remission across various time points, suggesting a durable and effective therapeutic impact. This progress could significantly improve the quality of life for many patients.
Sustained Esophageal Tissue Restoration and Clinical Remission
Initial findings from the RESOLVE trial's Phase 1b/2a portion underscore EP-104GI's capacity to foster enduring tissue repair in individuals diagnosed with eosinophilic esophagitis. Specifically, patients administered the highest dosage (8 mg/site) exhibited the most substantial enhancement in esophageal tissue health at the 12-week mark, nearing a complete return to normal physiological function. This remarkable improvement signals a potent therapeutic effect, targeting the underlying inflammation and damage characteristic of EoE. The consistency of these results across different patient cohorts emphasizes the drug's reliable performance in promoting significant and visible healing within the esophagus, which is crucial for alleviating symptoms and preventing disease progression. The ongoing monitoring further validates these early successes, establishing a strong foundation for EP-104GI's potential as a leading treatment for this debilitating condition.
Further analysis at 36 weeks demonstrated that participants receiving 4 mg/site of EP-104GI maintained the significant tissue health benefits initially observed at 12 weeks. This sustained improvement is a critical indicator of the drug's long-term efficacy, preventing relapse and ensuring continued patient well-being. A compelling 58% of patients achieved clinical remission at 12 weeks, with this figure rising to 79% by 24 weeks, and remarkably, 67% sustained remission even at 52 weeks among those tracked. These statistics highlight EP-104GI's profound impact on disease control and its ability to keep the condition at bay over prolonged periods. The comprehensive follow-up on over 200 patient-months across 31 individuals reinforces the robustness of these findings, providing strong evidence for the drug's effectiveness in achieving and maintaining deep remission. Such outcomes are pivotal for patients seeking durable solutions for EoE management.
Favorable Safety Profile and Treatment Tolerability
A key aspect of EP-104GI's successful trial results is its excellent safety profile. Throughout the RESOLVE trial, no severe adverse events have been documented, a testament to the drug's gentle yet effective action. This absence of serious complications provides considerable reassurance for both patients and healthcare providers, addressing concerns often associated with new therapeutic interventions. Moreover, the trial specifically reported no instances of oral candidiasis, a common side effect seen with other treatments for eosinophilic esophagitis. This lack of a prevalent fungal infection further distinguishes EP-104GI as a highly tolerable option, enhancing its appeal for long-term use where patient comfort and adherence are paramount. The meticulous monitoring of all participants across various dosage levels has consistently confirmed this benign safety record, solidifying confidence in the drug's overall profile.
The tolerability of EP-104GI has been consistently highlighted across all dosage groups, extending even to the highest dose of 8mg/site. This widespread acceptance by patients without significant discomfort or side effects is a crucial factor for a medication intended for chronic conditions like eosinophilic esophagitis. High tolerability often translates to better patient compliance and, consequently, more effective treatment outcomes. The data from September 2025, specifically from Cohort nine of the dose escalation phase, further corroborated these findings, demonstrating that even at increased dosages, the drug remained well-tolerated. These consistent reports across different phases and dosages of the trial underscore EP-104GI's potential as a patient-friendly treatment, capable of delivering therapeutic benefits without imposing an undue burden of side effects. The established safety and tolerability make it a strong candidate for future clinical application, offering a balanced approach to managing EoE.