Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EP-104GI · 1 trial · 1 indication
TEAEs will be summarized by dose/cohort
TEAEs will be summarized by dose/cohort and severity (mild, moderate, severe).
Cortisol will be will be summarized by dose/cohort and over time and compared to pre-dose values. A prolonged and clinically significant reduction in cortisol may indicate adrenal insufficiency.
Plasma concentrations of fluticasone propionate over time will be used to calculate PK parameters for each dose/cohort.
Physical examination results, BMI and weight will be summarized by dose/cohort and over time and compared to pre-dose values.
The EoEHSS scores the stage and grade of 8 histologic items: eosinophil inflammation, basal zone hyperplasia, dilated intercellular spaces, eosinophil abscesses, surface layering, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis), on separate 4-point Likert scales. A composite EoEHSS grade and stage scores are calculated by summing the individual grade and stage items and dividing by the maximum score for evaluated items (range, 0-1). A lower score indicates improvement.
| Arm | Type | Description |
|---|---|---|
| EP-104GI 4 mg | EXPERIMENTAL | 4 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 8 mg | EXPERIMENTAL | 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 20 mg | EXPERIMENTAL | 8 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 30 mg | EXPERIMENTAL | 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 48 mg | EXPERIMENTAL | 12 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 64 mg | EXPERIMENTAL | 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 80 mg | EXPERIMENTAL | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 96 mg | EXPERIMENTAL | 16 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 120 mg | EXPERIMENTAL | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI Dose A or matching vehicle control | PLACEBO_COMPARATOR | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI 160 mg | EXPERIMENTAL | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| EP-104GI Dose B or matching vehicle control | PLACEBO_COMPARATOR | 20 submucosal injections of EP-104GI administered during an EGD procedure at the Baseline/Dosing visit. |
| Name | Type | Description |
|---|---|---|
| EP-104GI | DRUG | Extended-release fluticasone propionate \[FP\] for injectable suspension for gastrointestinal administration, Powder suspended in vehicle |
| Matching vehicle control | OTHER | A sterile liquid containing sterile water and excipients necessary to prepare a uniform suspension of the powder. |
Inclusion Criteria: * Symptomatic EoE; * For women of childbearing potential, a negative pregnancy test and willing to use a highly effective method of birth control until end of study; * Willing and able to adhere to study-related procedures and visit schedule; * Willing and able to provide inform...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tezepelumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 3 | PHASE3 | dupilumab |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | PHASE2 | Vonoprazan |
| Eupraxia Pharmaceuticals, Inc. | EPRX | 1 | PHASE1 | EP-104GI |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Dupilumab |
| Smith & Nephew plc Sponsored ADR | SNN | 1 | - | Undisclosed |
EP-104GI is an investigational small molecule being developed for the treatment of eosinophilic esophagitis (EoE), a chronic allergic inflammatory condition of the esophagus. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
The specific molecular target of EP-104GI has not been disclosed. It is a small molecule therapeutic being evaluated for its ability to treat eosinophilic esophagitis, but the precise mechanism of action is not publicly available at this time.
EP-104GI is being developed by Eupraxia Pharmaceuticals Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol EPRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with eosinophilic esophagitis.
EP-104GI is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety, tolerability, and potential efficacy in treating eosinophilic esophagitis.
EP-104GI is being evaluated in a Phase 1 clinical trial registered as NCT05608681. This randomized, double-blind, placebo-controlled study is recruiting 117 adults with eosinophilic esophagitis across multiple countries, including Australia, Canada, the Netherlands, New Zealand, Switzerland, and the United Kingdom.
No alternative names for EP-104GI have been reported. It is a distinct investigational compound developed by Eupraxia Pharmaceuticals Inc. and is not known to be identical to any other marketed or investigational drug.