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- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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) (North Ballroom 120D) - Oct 9, 2025 - Abstract #ACG2025ACG_7037;
P1/2
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.
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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 (Exhibit Hall) - Aug 29, 2025 - Abstract #ACG2025ACG_1200;
P1/2
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.
- ||| fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Enrollment change, Trial completion date, Trial primary completion date: RESOLVE: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - Aug 18, 2025
P1/2, N=117, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
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. N=57 --> 117 | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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 (Poster Stage 1) - Jul 8, 2025 - Abstract #UEGW2025UEGW_1546;
P1/2
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.
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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 (Halls C-E, Lower Level - SDCC) - Mar 8, 2025 - Abstract #DDW2025DDW_2161;
P1/2
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.
- || MHU650 / Novartis, fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
P2 data, Journal: 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 Central) - Nov 27, 2024
P2
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.
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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 (In Person) - Sep 25, 2024 - Abstract #ACRConvergence2024ACR_Convergence_3542;
P2
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.
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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 (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_4410;
P1/2
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).
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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 (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_2709;
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.
- ||| fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Enrollment change, Trial completion date, Trial primary completion date: RESOLVE: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - Jul 29, 2024
P1/2, N=57, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
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. N=24 --> 57 | Trial completion date: Nov 2024 --> Dec 2025 | Trial primary completion date: Nov 2024 --> Dec 2025
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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 (Science Lounge) - Jul 18, 2024 - Abstract #UEGW2024UEGW_1088;
P1/2
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.
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
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) (A1) - Mar 29, 2024 - Abstract #EULAR2024EULAR_2107;
P2
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.
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
EFFICACY OUTCOMES IN PATIENTS WITH KNEE OSTEOARTHRITIS: PER-PROTOCOL ANALYSES FROM SPRINGBOARD, A PHASE 2, RANDOMIZED, 24-WEEK STUDY OF EP-104IAR (LONG-ACTING INTRA-ARTICULAR INJECTION OF FLUTICASONE PROPIONATE) () - Mar 27, 2024 - Abstract #OARSI2024OARSI_188;
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
INITIAL RESULTS FROM RESOLVE, AN ONGOING PHASE 1B DOSE-ESCALATION STUDY OF EP-104GI (LONG-ACTING FLUTICASONE PROPIONATE INJECTABLE SUSPENSION) FOR EOSINOPHILIC ESOPHAGITIS (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_937;
P1/2
Conclusions Initial data support that the ongoing study of local delivery of FP via EP-104IAR is feasible and suggest it is safe. This novel therapy has a potential interval of 6-12 months between inter-esophageal injections, without side-effects typically associated with corticosteroids.
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Phase classification: RESOLVE: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - Feb 15, 2024
P1/2, N=24, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
This novel therapy has a potential interval of 6-12 months between inter-esophageal injections, without side-effects typically associated with corticosteroids. Phase classification: P1b --> P1/2
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
EP-104IAR (Extended-Release Fluticasone Propionate for Injectable Suspension): Topline and Key Secondary Results from a Phase 2 Randomized, Double-blind, Vehicle-Controlled Trial in Subjects with Knee Osteoarthritis (Poster Hall; In Person) - Oct 24, 2023 - Abstract #ACRConvergence2023ACR_Convergence_4570;
In subjects with moderate pain, significant pain-relief persisted for 17 weeks. Responder analyses in subjects with moderate pain demonstrated that clinically meaningful differences persisted for the majority of the study.
- | fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Trial completion date, Trial primary completion date: RESOLVE: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - Aug 14, 2023
P1b, N=24, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Responder analyses in subjects with moderate pain demonstrated that clinically meaningful differences persisted for the majority of the study. Trial completion date: Sep 2023 --> Nov 2024 | Trial primary completion date: Sep 2023 --> Nov 2024
- |||| fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Trial completion: Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - Jun 8, 2023
P2, N=318, Completed, Sponsor: Eupraxia Pharmaceuticals Inc.
Trial completion date: Sep 2023 --> Nov 2024 | Trial primary completion date: Sep 2023 --> Nov 2024 Active, not recruiting --> Completed
- || fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Enrollment open: RESOLVE: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - May 15, 2023
P1b, N=24, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- ||| fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Enrollment closed: Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - Jan 18, 2023
P2, N=318, Active, not recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
New P1 trial: RESOLVE: A Trial to Evaluate EP-104GI in Adults With Eosinophilic Esophagitis (EoE). (clinicaltrials.gov) - Nov 8, 2022
P1b, N=24, Not yet recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
- || fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Trial completion date, Trial primary completion date: Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - Apr 1, 2022
P2, N=300, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Recruiting --> Active, not recruiting Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Mar 2023
- |||| fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Enrollment open: Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - Sep 12, 2021
P2, N=300, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Trial completion date: Oct 2022 --> Mar 2023 | Trial primary completion date: Oct 2022 --> Mar 2023 Not yet recruiting --> Recruiting
- || fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Trial completion date, Trial primary completion date: Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - Jan 13, 2021
P2, N=238, Not yet recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Not yet recruiting --> Recruiting Trial completion date: Sep 2021 --> Aug 2022 | Trial primary completion date: Sep 2021 --> Aug 2022
- || fluticasone propionate controlled release (EP-104IAR) / Eupraxia Pharma, Syreon
PK/PD data, Journal: Pharmacokinetic Profile of Intra-articular Fluticasone Propionate Microparticles in Beagle Dog Knees. (Pubmed Central) - Jan 9, 2020
Highest concentrations of fluticasone propionate in synovial fluid and cartilage generally occurred 5 days postdose in both dose groups and declined with a half-life of approximately 11 to 14 days. Conclusions EP-104IAR is capable of providing a safe and prolonged local exposure to a corticosteroid in the synovial joint while minimizing systemic exposure, with peak exposures occurring within a matter of days after dosing before declining in all tissues in a predictable manner.
- | fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
New P2 trial: Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee (clinicaltrials.gov) - Oct 9, 2019
P2, N=238, Not yet recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
- | fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Trial completion: STEPUP: Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis (clinicaltrials.gov) - Jan 24, 2018
P1, N=32, Completed, Sponsor: Eupraxia Pharmaceuticals Inc.
Conclusions EP-104IAR is capable of providing a safe and prolonged local exposure to a corticosteroid in the synovial joint while minimizing systemic exposure, with peak exposures occurring within a matter of days after dosing before declining in all tissues in a predictable manner. Active, not recruiting --> Completed
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Enrollment closed, Trial primary completion date: STEPUP: Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis (clinicaltrials.gov) - Mar 21, 2017
P1, N=32, Active, not recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2017 --> Dec 2017
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Enrollment open: STEPUP: Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis (clinicaltrials.gov) - Apr 19, 2016
P1, N=32, Recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2017 --> Dec 2017 Not yet recruiting --> Recruiting
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
Trial initiation date: STEPUP: Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis (clinicaltrials.gov) - Mar 2, 2016
P1, N=32, Not yet recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.
Not yet recruiting --> Recruiting Initiation date: Jan 2016 --> Apr 2016
- fluticasone propionate controlled release (EP-104) / Eupraxia Pharma
New P1 trial: STEPUP: Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis (clinicaltrials.gov) - Nov 21, 2015
P1, N=32, Not yet recruiting, Sponsor: Eupraxia Pharmaceuticals Inc.