fluticasone propionate controlled release (EP-104) / Eupraxia Pharma - LARVOL DELTA

Improvements in Dysphagia Following Single Administration of EP-104GI Persist Over 52 Weeks During Dose Escalation in the Ongoing RESOLVE Phase 1b/2 Trial in Eosinophilic Esophagitis (ACG 2026) - P1/2 | "Single administration of EP-104GI at baseline for all cohorts (32 participants) resulted in stable mean plasma fluticasone propionate concentrations >100 pg/ml over up to 52 weeks following an initial peak. EP-104GI was generally safe and well tolerated to date, with no drug-related serious adverse events. Treatment-emergent adverse events were reported in 25 participants, all mild or moderate, with the most common (â¥3 events) including nausea, chest pain, dizziness, dyspepsia and nasopharyngitis."

P1/2 data • Dyspepsia • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Infectious Disease

IMPROVEMENTS IN HISTOPATHOLOGICAL FEATURES OF EOSINOPHILIC ESOPHAGITIS FOLLOWING A SINGLE ADMINISTRATION OF EP-104GI DURING DOSE ESCALATION IN THE PHASE 1B/2 RESOLVE STUDY (UEGW 2026) - No abstract available

P1/2 data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

SINGLE ADMINISTRATION OF ESCALATING DOSES OF EP-104GI LEADS TO IMPROVEMENTS IN FREQUENCY AND SEVERITY OF DYSPHAGIA UP TO 52 WEEKS IN THE RESOLVE PHASE 1B/2 STUDY IN EOSINOPHILIC ESOPHAGITIS (UEGW 2026) - No abstract available

P1/2 data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Eupraxia Pharmaceuticals Reports Symptom Response Data from its Ongoing Phase 1b/2a RESOLVE Trial, Including New Data on Odynophagia (Painful Swallowing) in Eosinophilic Esophagitis Patients (Eupraxia Pharmaceuticals Press Release) - "Key highlights from the odynophagia analysis: At baseline 62% of the EoE patients reported either moderate or severe odynophagia (n=13); At 2, 4, 8 and 12 weeks post treatment, 31% of patients reported moderate or severe odynophagia (n=13); At 24, 36 and 52 weeks, 25% of patients reported moderate or severe odynophagia (n = 12,12 and 8 respectively); At baseline, 15% of patients recorded no odynophagia, at 52 weeks, 50% of patients recorded no odynophagia...Key highlights from the dysphagia analysis: At baseline 77% of the EoE patients reported moderate or severe dysphagia (n=13); At 12 weeks post treatment, 54% of patients reported moderate or severe dysphagia (n=13); At 24 and 52 weeks, only 25% of patients reported moderate or severe dysphagia (n = 12 and 8 respectively)."

P1/2 data • Eosinophilic Esophagitis • Immunology

Eupraxia Pharmaceuticals Reports Second Quarter 2026 Financial Results (The Manila Times) - "New data presented at Digestive Disease Week (DDW) demonstrating improvement of fibrosis and inflammation following a single treatment of EP-104GI...EREFS is a standardized visual scoring system that gastroenterologists use when performing an endoscopy in EoE patients to assess the severity of inflammation and fibrosis in the esophagus. EREFS data reported by Eupraxia demonstrated a relationship between the number of injections of EP-104GI and the overall improvements in the EREFS findings....Sub scores of EoEHSS are reported to specifically evaluate the tissue inflammation and tissue architecture (which is a measure of fibrosis). The sub-score data from the highest dose cohorts in the RESOLVE study were reported for the first time at DDW and generally demonstrated improvement in both inflammation and fibrosis following treatment with EP-104GI."

P1/2 data • Eosinophilic Esophagitis • Immunology

Eupraxia reports 36-week data from EoE treatment trial (Investing.com) - "The data represents the first 36-week symptom response and tissue health results from Cohort 9, which received a 20 x 8 mg dose, according to a press release statement. Three patients in this cohort demonstrated reductions in EoEHSS Stage and Grade of 0.59 and 0.53 at week 36, representing 90% and 88% reductions respectively from baseline...Peak Eosinophil Count decreased 72% from baseline in Cohort 9 at week 36, the largest reduction among all dose cohorts in the trial....The Phase 2b portion of the RESOLVE trial, a randomized placebo-controlled study, is currently recruiting patients for the 120mg and 160mg doses. Top-line data from this phase is expected in the fourth quarter of 2026."

P1/2 data • P2b data • Trial status • Eosinophilic Esophagitis

SINGLE ADMINISTRATION OF ESCALATING DOSES OF EP-104GI LEADS TO PERSISTENT IMPROVEMENTS IN HISTOLOGICAL FEATURES OF EOSINOPHILIC ESOPHAGITIS OVER 36 WEEKS IN RESOLVE, A PHASE 1B/2 DOSE ESCALATION AND OPTIMIZATION TRIAL (DDW 2026) - No abstract available

P1/2 data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Eupraxia Pharmaceuticals Reports Additional 52-week Follow-up Data from the RESOLVE Trial in Eosinophilic Esophagitis (EoE) Demonstrating Consistent Results after Dosing with EP-104GI (GlobeNewswire) - "In Cohort 6, a durable clinical symptom response was observed 52 weeks after a single administration of EP-104GI. All 3 patients in Cohort 6 maintained a clinical benefit and 2 out of 3 patients remain in clinical remission 52 weeks after treatment of EoE with EP-104GI. In combination with patients from Cohort 5, at 52 weeks, 4 out of 6 patients remain in clinical remission. At week 36, 67% of all patients in the trial that were measured at 36 weeks, were in clinical remission (Cohorts 5-7, n=9)....The top-line data from the Phase 2b part of the RESOLVE trial is expected in Q3 2026."

P1/2 data • Eosinophilic Esophagitis

Persistent Improvement in Dysphagia Symptoms for 52 Weeks Following a Single Administration of EP-104GI in RESOLVE, an Ongoing Phase 1b/2 Trial in Eosinophilic Esophagitis (Late-Breaking Abstract) (ACG 2025) - P1/2 | "Prior, completed cohorts, with single administrations of up to 12x2.5mg of EP-104GI resulted in sustained mean improvements in eosinophil counts, histological scores and SDI score over 24 weeks. After 12, 24, 36 and 52 weeks respectively, following a single administration of 12x4mg EP-104GI, participants reported mean relative changes from baseline in SDI total score of -41%, -65%, -65% and -35% (mean absolute changes: -2.3, -3.7, -3.7 and -2). Changes from baseline in individual SDI subscales showed improvements in both frequency (-43%, -71%, -43%, -29%) and intensity (-40%, -60%, -80%, -40%) of dysphagia at week 12, 24, 36 and 52, respectively."

Late-breaking abstract • P1/2 data • Candidiasis • Endocrine Disorders • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Nephrology • Renal Disease • Solid Tumor

Results From Dose Escalation Cohorts 1-6 of RESOLVE, an Ongoing Phase 1b/2a Study of EP-104GI (Long-Acting Fluticasone Propionate Injectable Suspension) for Eosinophilic Esophagitis (ACG 2025) - P1/2 | "Previously reported data from cohorts 1-2 (total doses 4-8 mg) showed decreases in SDI for all patients, which were maintained to Week 24 where follow-up data are available. A decrease in mean PEC was observed for all patients in Cohort 2.Cohorts 3-6 (total doses 20-64 mg) showed symptom (SDI) reductions at Week 12 for 11/12 patients; the majority maintained to Week 24. Mean PEC declined for 10/12 participants at Week 12, including one patient in Cohort 5 who achieved PEC ≤6 at all biopsy sites, representing complete histological remission."

P1/2 data • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Solid Tumor

RESULTS FROM RESOLVE, AN ONGOING PHASE 1B/2A STUDY OF EP-104GI (LONG-ACTING FLUTICASONE PROPIONATE INJECTABLE SUSPENSION) FOR EOSINOPHILIC ESOPHAGITIS: DOSE ESCALATION COHORTS 3 THROUGH 6 (UEGW 2025) - P1/2 | "Therapy for EoE includes proton-pump inhibitors, swallowed topical corticosteroids, dupilumab, and dietary elimination, but these are not always effective and have potential side effects.EP-104GI is a long-acting fluticasone propionate (FP) injectable suspension being developed as a first-in-class treatment for EoE. These data support that local delivery of FP via EP-104GI has been feasible and safe in the ongoing study. Higher doses yield improved patient responses such as histological remission, enhanced patient-reported symptom scores, and favorable histology results, without the occurrence of corticosteroids-related side effects."

P1/2 data • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

RESOLVE: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - P1/2 | N=117 | Recruiting | Sponsor: Eupraxia Pharmaceuticals Inc. | N=57 ➔ 117 | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

RESULTS FROM DOSE ESCALATION COHORTS 1 THROUGH 5 FROM RESOLVE, AN ONGOING PHASE 1B/2A DOSE-ESCALATION STUDY OF EP-104GI (LONG-ACTING FLUTICASONE PROPIONATE INJECTABLE SUSPENSION) FOR EOSINOPHILIC ESOPHAGITIS (DDW 2025) - P1/2 | "Therapy for EoE includes swallowed topical corticosteroids, dupilumab, and dietary elimination, but these are not always effective and have potential side-effects. These data support that the ongoing study of local delivery of FP via EP-104IAR is feasible and safe. Higher doses yield improved patient responses such as histological remission, enhanced patient-reported symptom scores, and favorable histology results, without occurrence of corticosteroids-related side-effects."

P1/2 data • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

Eupraxia Pharmaceuticals to Present at Investor and Scientific Conferences in April and May (GlobeNewswire) - "Eupraxia Pharmaceuticals...will be presenting a poster on the Company’s behalf at the Osteoarthritis Research Society International ('OARSI') World Congress 2025, being held April 24-27, 2025 in Incheon (Seoul), South Korea."

P1/2 data • P2 data • Eosinophilic Esophagitis • Osteoarthritis

Eupraxia Pharmaceuticals Announces Positive Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis (PRNewswire) - P1b/2a | N=57 | NCT05608681 | Sponsor: Eupraxia Pharmaceuticals Inc | "Histological scores and symptom scores continue to improve as EP-104GI dose, and area of esophageal coverage, increase; Cohort 6 showed the greatest symptom relief scores ('SDI') of all cohorts to date at 12 weeks; Cohort 6 had the greatest magnitude and percentage change in tissue health scores ('EoEHSS') of any cohort to date at 12 weeks; Cohort 6 saw the greatest reduction in Peak Eosinophil Count ('PEC') of any cohort to date; Cohort 5 demonstrated the greatest symptom score reduction (SDI) seen to date at 24 weeks, showing continuously improving symptom relief over that time; For tissue health (EoEHSS) and PEC there is a clear dose-response from Cohorts 3 to 6, with Cohort 6 showing the greatest response; No serious adverse events nor any events of oral or gastrointestinal candidiasis were reported in any of the six cohorts; Cohort 7 is fully enrolled, with 12-week data expected in Q2 2025"

P1/2 data • Eosinophilic Esophagitis

EP-104IAR (Long-Acting Intra-Articular Injection of Fluticasone Propionate) Shows Sustained Improvement in Pain for Subjects with Moderate Baseline Pain and BMI Less Than 30 in SPRINGBOARD, a Phase 2, Randomized, 24-Week Study of Osteoarthritis of the Knee (ACR Convergence 2024) - P2 | "In this subgroup analysis of patients with moderate baseline pain and/or BMI < 30, a single dose of EP-104IAR provided statistically significant improvement in WOMAC scores for up to 22 weeks. This analysis reinforces that EP-104IAR has potential for sustained clinically meaningful benefit in KOA, which is of particular relevance in patients with moderate pain and/or reduced risk of progression to severe pain who may require treatment for a longer period of time before progressing to surgical intervention. Phase 3 trials of EP-104IAR are now planned."

Clinical • P2 data • Cardiovascular • Diabetes • Hypertension • Immunology • Metabolic Disorders • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Eupraxia Pharmaceuticals Announces Positive Data from Fifth Cohort of RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis (PRNewswire) - P1b/2 | N=24 | RESOLVE (NCT05608681) | Sponsor: Eupraxia Pharmaceuticals Inc. | "The results announced today from the fifth cohort of the RESOLVE trial, for treatment of EoE, are derived from 12, 4 mg injections of EP-104GI (total dose of 48 mg) administered to the lower two-thirds of each patient's esophagus. The data show: Straumann Dysphagia Index ('SDI'), a patient-reported outcome measure designed to assess symptom severity, was lower for all three patients post-administration with peak reductions up to 3 points (50% from baseline). At 12 weeks post-administration, mean SDI reduction was 41% or 2.3 points. Eosinophilic Esophagitis Histology Scoring System ('EoEHSS') scores, which evaluate the severity and extent of EoE, showed the largest percent reduction of any cohort to date at 12 weeks, with peak reduction of 100% in Stage and Grade scores, and a mean 54% reduction in Composite Stage and Grade scores."

P1/2 data • Eosinophilic Esophagitis

Efficacy and Pharmacokinetic Results From Ongoing Dose Escalation in RESOLVE, a Phase 1b/2a Study of EP-104GI (Extended-Release Fluticasone Propionate Intra-Esophageal Injection) for Eosinophilic Esophagitis (ACG 2024) - P1/2 | "Cohorts 1-4 (Fig 1) have shown mean decreases in SDI maintained to Week 24 (Cohorts 1 and 2). PK data show increasing FP exposure with dose with the anticipated low initial peak followed by stable concentrations throughout follow-up. Mean PEC at injected sites has declined for Cohorts 2-4 at the latest timepoint currently assessed (Week 12 for Cohorts 2 and 3; Week 4 for Cohort 4)."

Clinical • P1/2 data • PK/PD data • Eosinophilia • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

Pharmacokinetics and Local Tolerability of EP-104GI, an Extended-Release Formulation of Fluticasone Propionate for Treatment of Eosinophilic Esophagitis, After Intra-Esophageal Injection in Mini-Pigs (ACG 2024) - "A plasma C max of 25 pg/mL was observed 1 day after sub-mucosal injection of EP-104GI in the esophagus. After that, plasma FP was stable from 9-15 pg/mL for the next 6 weeks, showing EP-104GI achieved extended FP release. For an FP solution given by oral gavage, C max of 454 pg/mL was at 4 hours and thereafter decreased rapidly with concentrations below 4 pg/mL by Day 10."

PK/PD data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Eupraxia Pharmaceuticals to Present at American College of Gastroenterology Annual Scientific Meeting 2024 (Eupraxia Pharmaceuticals Press Release) - "Poster Details: [1] Pharmacokinetics and Local Tolerability of EP-104GI, an Extended-Release Formulation of Fluticasone for Treatment of Eosinophilic Esophagitis, after Intra-Esophageal Injection in Mini-Pigs; [2] Efficacy and Pharmacokinetic Results From Ongoing Dose Escalation in RESOLVE, a Phase 1b/2a Study of EP-104GI (Extended-Release Fluticasone Propionate Intra-Esophageal Injection) for Eosinophilic Esophagitis"

P1/2 data • Preclinical • Eosinophilic Esophagitis

RESULTS FROM DOSE ESCALATION IN RESOLVE, AN ONGOING PHASE 1B/2A DOSE-ESCALATION STUDY OF EP-104GI (EXTENDED-RELEASE FLUTICASONE PROPIONATE INTRA-ESOPHAGEAL INJECTION) FOR EOSINOPHILIC ESOPHAGITIS (UEGW 2024) - P1/2 | "Therapy for EoE includes swallowed/topical corticosteroids, dupilumab, proton pump inhibitors, and dietary elimination; but these are not always effective.EP-104GI is an extended-release fluticasone propionate (FP) intra-esophageal injection being developed as a novel treatment for EoE. A novel diffusion-based localized delivery of FP via EP-104GI injection into the esophagus is feasible and safe in patients with EoE in this initial escalating dose cohort study. Initial efficacy data show improvement in symptom outcomes and histological findings which may increase with dose. These findings support the potential for extended intervals of at least 6 months between injections."

P1/2 data • Endocrine Disorders • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation • Nephrology • Pain • Renal Disease

Efficacy and safety of a diffusion-based extended-release fluticasone propionate intra-articular injection (EP-104IAR) in knee osteoarthritis (SPRINGBOARD): a 24-week, multicentre, randomised, double-blind, vehicle-controlled, phase 2 trial. (PubMed, Lancet Rheumatol) - P2 | "These phase 2 results suggest that EP-104IAR has the potential to offer clinically meaningful pain relief in knee osteoarthritis for an extended period of up to 14 weeks, longer than published data for currently marketed corticosteroids. There were minimal effects on glucose and cortisol, and stable fluticasone propionate concentrations in plasma. The safety and efficacy of EP-104IAR will be further evaluated in phase 3 trials, including the possibility of bilateral and repeat dosing with EP-104IAR."

Journal • P2 data • Immunology • Osteoarthritis • Pain • Rheumatology

Eupraxia Pharmaceuticals Announces Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis (PRNewswire) - P1b/2 | N=24 | RESOLVE (NCT05608681) | Sponsor: Eupraxia Pharmaceuticals Inc. | "Eupraxia Pharmaceuticals...today announced additional positive clinical data from its RESOLVE Phase 1b/2a trial, which is evaluating the safety and efficacy of EP-104GI as a treatment for eosinophilic esophagitis ('EoE')....New Clinical Data from the Fourth Cohort of the RESOLVE Trial: Straumann Dysphagia Index ('SDI')1, a patient-reported outcome measure designed to assess symptom severity, was lower for all three patients post-administration with peak reductions up to four points (67% from baseline). At 12 weeks post-administration, SDI was reduced by a mean of 45% or 3.3 points – a level comparable with currently approved therapies....New Clinical Data from the Third Cohort in the RESOLVE Trial: SDI was 50% lower in one of two evaluable patients at 24 weeks. A third patient in this cohort discontinued evaluation for reasons unrelated to the study."

P1/2 data • Eosinophilic Esophagitis • Immunology

A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - P1/2 | N=57 | Recruiting | Sponsor: Eupraxia Pharmaceuticals Inc. | N=24 ➔ 57 | Trial completion date: Nov 2024 ➔ Dec 2025 | Trial primary completion date: Nov 2024 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

EFFICACY OF A NOVEL LONG-ACTING FLUTICASONE PROPIONATE INTRA ARTICULAR INJECTION (EP-104IAR) IN KNEE OSTEOARTHRITIS: PER-PROTOCOL ANALYSIS OF A RANDOMISED, DOUBLE-BLIND, PHASE 2 TRIAL OF EP-104IAR VS VEHICLE PLACEBO (SPRINGBOARD) (EULAR 2024) - P2 | "In this PP analysis, a single dose of EP-104IAR provided statistically and clinically meaningful improvement in WOMAC scores for up to 20 weeks compared to vehicle, with greater separation between treatment arms than in preliminary intent-to-treat analyses 1 . The PP analysis demonstrated duration of effect is longer than the currently approved immediate- and extended-release corticosteroids. This analysis and previously reported safety data reinforces that EP-104IAR has potential for sustained clinically meaningful benefit in KOA, addressing a significant unmet need."

Clinical • P2 data • Immunology • Osteoarthritis • Pain • Rheumatology