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- 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
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
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: A Trial to Evaluate EP-104IAR 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: A Trial to Evaluate EP-104IAR 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: A Trial to Evaluate EP-104IAR 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-104IAR) / Eupraxia Pharma, Syreon
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-104IAR) / Eupraxia Pharma, Syreon
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-104IAR) / Eupraxia Pharma, Syreon
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-104IAR) / Eupraxia Pharma, Syreon
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-104IAR) / Eupraxia Pharma, Syreon
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.