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- ||||||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion, Trial completion date: FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - Sep 23, 2024
P3, N=218, Completed, Sponsor: Ellodi Pharmaceuticals, LP
Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Aug 2024
- ||||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Enrollment closed: FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - Apr 11, 2024
P3, N=218, Active, not recruiting, Sponsor: Ellodi Pharmaceuticals, LP
Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Aug 2024 Recruiting --> Active, not recruiting
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
FLUTICASONE PROPIONATE ORAL DISINTEGRATING TABLET, APT-1011, LEADS TO A GREATER COMPLETE SYMPTOMATIC RESPONSE RATE COMPARED TO PLACEBO IN SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS (EOE) (146AB - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_6478;
Amongst subjects with complete symptom response, eosinophilic remission was only seen in those receiving APT-1011. These data indicate that the depth of symptom resolution with APT-1011 therapy corresponds with eosinophilic remission, making APT-1011 a promising therapy for these important treatment goals.
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
FLUTICASONE PROPRIONATE ORAL DISINTEGRATING TABLET, APT-1011, IMPROVES FIBROSTENOTIC FEATURES OF STRICTURES AND GRADE 2/3 RINGS IN SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS (EOE) (146AB - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_6477;
The data from this phase 3 study are consistent with outcomes shown in phase 2b. Collectively, these data suggest APT-1011 is a promising treatment for the fibrostenotic complications of EoE.
- ||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion date, Trial primary completion date: FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - Dec 21, 2023
P3, N=200, Recruiting, Sponsor: Ellodi Pharmaceuticals, LP
- || Jorveza (budesonide orodispersible tablets) / Dr Falk
Review, Journal: Novel corticosteroid formulations in the treatment of eosinophilic esophagitis: what is the evidence? (Pubmed Central) - Nov 3, 2023
Budesonide orodispersible tablet (BOT) and budesonide oral suspension (BOS) both surpassed placebo formulations regarding the efficacy of inducing and maintaining histologic, symptomatic and endoscopic remission...Fluticasone propionate (APT-1011) achieved and maintained histologic and endoscopic responses in the majority of patients, whereas only a positive trend was demonstrated for symptomatic improvement...Current evidence supports long-term treatment with novel corticosteroid formulations, challenging the established treatment paradigm of EoE. BOT appears to be the most effective steroid therapy, although head-to-head comparative trials between STCs are needed.
- || fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion date: FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - Jul 12, 2023
P3, N=200, Recruiting, Sponsor: Ellodi Pharmaceuticals, LP
BOT appears to be the most effective steroid therapy, although head-to-head comparative trials between STCs are needed. Trial completion date: Oct 2025 --> Mar 2025
- |||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Enrollment open: FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - Jan 6, 2023
P3, N=200, Recruiting, Sponsor: Ellodi Pharmaceuticals, LP
Trial completion date: Oct 2025 --> Mar 2025 Not yet recruiting --> Recruiting
- |||||||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
New P3 trial: FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - Dec 2, 2022
P3, N=200, Not yet recruiting, Sponsor: Ellodi Pharmaceuticals, LP
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion: FLUTEEN: Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial (clinicaltrials.gov) - Nov 9, 2022
P3, N=5, Completed, Sponsor: Ellodi Pharmaceuticals, LP
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- ||||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion: Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - Nov 9, 2022
P3, N=143, Completed, Sponsor: Ellodi Pharmaceuticals, LP
Active, not recruiting --> Completed Active, not recruiting --> Completed
- || fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Clinical, Journal: Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) for Eosinophilic Esophagitis: Randomized Controlled Trial. (Pubmed Central) - Nov 2, 2022
P2
APT-1011 dosing regimens were superior for histologic and endoscopic responses, and for reduction in dysphagia frequency vs placebo. Based on the symptom improvement and assessment of adverse events together with the histologic response rate, 3 mg once daily at bedtime dose showed the most favorable risk-benefit profile.
- ||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial primary completion date: Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - Aug 18, 2022
P3, N=143, Active, not recruiting, Sponsor: Ellodi Pharmaceuticals, LP
Based on the symptom improvement and assessment of adverse events together with the histologic response rate, 3 mg once daily at bedtime dose showed the most favorable risk-benefit profile. Trial primary completion date: Aug 2022 --> May 2022
- | Journal: Update on Emerging Pharmacologic Therapies for Patients With Eosinophilic Esophagitis. (Pubmed Central) - May 6, 2022
Some of these medications have proven efficacious for other atopic conditions and show incredible promise for the treatment of eosinophilic gastrointestinal diseases. Further studies will be needed to determine long-term treatment outcomes for each of these drugs.
- ||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial primary completion date: Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - Apr 14, 2022
P3, N=143, Active, not recruiting, Sponsor: Ellodi Pharmaceuticals, LP
Further studies will be needed to determine long-term treatment outcomes for each of these drugs. Trial primary completion date: Jul 2021 --> May 2022
- ||||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Enrollment closed, Enrollment change: FLUTEEN: Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial (clinicaltrials.gov) - Apr 12, 2022
P3, N=5, Active, not recruiting, Sponsor: Ellodi Pharmaceuticals, LP
Trial primary completion date: Jul 2021 --> May 2022 Recruiting --> Active, not recruiting | N=30 --> 5
- |||||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
New trial: Expanded Access Protocol for Patients With Eosinophilic Esophagitis (clinicaltrials.gov) - Oct 26, 2021
P=N/A, N=0, Available, Sponsor: Ellodi Pharmaceuticals, LP
- |||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
New P3 trial: FLUTEEN: Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial (clinicaltrials.gov) - Oct 19, 2021
P3, N=30, Recruiting, Sponsor: Ellodi Pharmaceuticals, LP
- |||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Enrollment closed: Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - Oct 14, 2021
P3, N=143, Active, not recruiting, Sponsor: Ellodi Pharmaceuticals, LP
Recruiting --> Active, not recruiting | N=30 --> 5 Recruiting --> Active, not recruiting
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Time to Clinically Meaningful Improvement in Dysphagia Frequency in Adults with Eosinophilic Esophagitis: A Post-Hoc Analysis From a Phase 2b Trial of APT-1011, a Fluticasone Propionate Oral Disintegrating Tablet (Mandalay Bay Ballroom EF) - Sep 8, 2021 - Abstract #ACG2021ACG_3641;
The mean dysphagia frequency reported at baseline ranged from 12-16, with the greatest reduction observed in the 3 mg HS group (-10.5; p value= 0.014 vs placebo) (Table 1). The dysphagia frequency threshold, based on the PGIC anchor-analysis, was determined as a 50% reduction, which correlated with the pre-defined PGIC outcomes.
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Patient-Reported Symptom Improvement Following Treatment With APT-1011 in Patients with Eosinophilic Esophagitis as Measured by the PROSE: Results from FLUTE, A Phase 2b Clinical Trial (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_1634;
At baseline the mean number of episodes was 14.10 vs 15.59 for 3mg HS vs placebo and decreased after 12 weeks of treatment by -10.55 and -6.00 respectively. Meaningful effect sizes were observed between the 3mg HS dose and placebo group for dysphagia frequency over 14 days (-0.460), as well as for the mean daily composite episode severity rating (-0.252).
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
[VIRTUAL] COMPLIANCE FOR THE PROSE DAILY DIARY: MEASURING COMPLETION RATES OF A NEW INSTRUMENT TO MEASURE DYSPHAGIA EPISODES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_4147;
The PROSE instrument was found to be minimally burdensome and easy to use for patients with EOE-related dysphagia. This study demonstrated good compliance at 80% with the PROSE in phase 2b.
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
[VIRTUAL] COMPLIANCE FOR THE PROSE DAILY DIARY: MEASURING COMPLETION RATES OF A NEW INSTRUMENT TO MEASURE DYSPHAGIA EPISODES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_1967;
The PROSE instrument was found to be minimally burdensome and easy to use for patients with EOE-related dysphagia. This study demonstrated good compliance at 80% with the PROSE in phase 2b.
- fluticasone propionate ODT (APT-1011) / Ellodi Pharma
[VIRTUAL] COMPLIANCE FOR THE PROSE DAILY DIARY: MEASURING COMPLETION RATES OF A NEW INSTRUMENT TO MEASURE DYSPHAGIA EPISODES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_136;
The PROSE instrument was found to be minimally burdensome and easy to use for patients with EOE-related dysphagia. This study demonstrated good compliance at 80% with the PROSE in phase 2b.
- || fluticasone propionate ODT (APT-1011) / Adare Pharma
Clinical, PK/PD data, Journal: Effect of Food Intake and Body Position on the Pharmacokinetics of Swallowed APT-1011, a Fluticasone Orally Disintegrating Tablet, in Healthy Adult Volunteers. (Pubmed Central) - Jun 22, 2021
There is low systemic exposure of fluticasone propionate with APT-1011. The rate of absorption was increased with a high-fat meal but decreased with hs dosing, suggesting the potential for longer dwell times in the esophagus.
- ||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial primary completion date: Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - Apr 22, 2021
P3, N=120, Recruiting, Sponsor: Ellodi Pharmaceuticals, LP
The rate of absorption was increased with a high-fat meal but decreased with hs dosing, suggesting the potential for longer dwell times in the esophagus. Trial primary completion date: Oct 2021 --> Jul 2021
- fluticasone propionate ODT (APT-1011) / Adare Pharma
[VIRTUAL] LOW RATES OF GLUCOCORTICOID-RELATED ADVERSE EFFECTS WITH LONG-TERM TREATMENT OF EOSINOPHILIC ESOPHAGITIS WITH FLUTICASONE PROPIONATE ORALLY DISINTEGRATING TABLET (APT-1011): RESULTS FROM 52 WEEKS OF EXPOSURE IN A PHASE 2B TRIAL. (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_3174;
Adrenal insufficiency based on ACTH stimulation testing alone was reported uncommonly (2%) and normalized after short term cessation of study drug, raising the question of test accuracy. Further studies are needed to identify factors associated with potential side effects of topical glucocorticoids and potential pitfalls in cortisol testing.
- fluticasone propionate ODT (APT-1011) / Adare Pharma
[VIRTUAL] FLUTICASONE PROPIONATE ORALLY DISINTEGRATING TABLET (APT-1011) IMPROVES HISTOLOGIC, ENDOSCOPIC AND SYMPTOMATIC RESPONSES IN EOSINOPHILIC ESOPHAGITIS PATIENTS WITH FIBRO-STENOTIC FEATURES: RESULTS FROM A PHASE 2B TRIAL (DDW Virtual) - Mar 15, 2021 - Abstract #DDW2021DDW_1183;
The subgroup of EoE patients with strictures and/or Grade 2+ rings, thought to be difficult to treat, also had excellent response rates, showing resolution of these features in most subjects, particularly for the 3 mg HS dosing group. These data suggest APT-1011 could be a promising treatment for the fibro-stenotic complications of EoE.
- | fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion date: Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - Feb 18, 2021
P3, N=120, Recruiting, Sponsor: Ellodi Pharmaceuticals, LP
These data suggest APT-1011 could be a promising treatment for the fibro-stenotic complications of EoE. Trial completion date: Dec 2021 --> May 2022
- ||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion: FLUTE: Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (clinicaltrials.gov) - Jan 29, 2021
P2, N=106, Completed, Sponsor: Adare Pharmaceuticals, Inc.
Trial completion date: Dec 2021 --> May 2022 Active, not recruiting --> Completed
- || fluticasone propionate ODT (APT-1011) / Adare Pharma
Clinical, Journal: Randomised clinical trial: the safety and tolerability of fluticasone propionate orally disintegrating tablets versus placebo for eosinophilic oesophagitis. (Pubmed Central) - Sep 16, 2020
Exploratory efficacy outcomes demonstrated improvement in histologic and endoscopic findings as well evidence of symptom improvement. The results of this study support the continued development of APT-1011 for the treatment of EoE (NCT-01386112).
- fluticasone propionate ODT (APT-1011) / Adare Pharma
[VIRTUAL] Safety and Efficacy of Long-Term Treatment of EoE With Fluticasone Propionate Orally Disintegrating Tablet (APT-1011): Results From 40 Weeks Treatment in a Phase 2b Randomized Double-Blind Placebo-Controlled Trial () - Aug 25, 2020 - Abstract #ACG2020ACG_487;
The results of this study support the continued development of APT-1011 for the treatment of EoE (NCT-01386112). Abstracts will be released on Friday, October 9, 2020.
- |||||||| fluticasone propionate ODT (APT-1011) / Ellodi Pharma
New P3 trial: Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - Feb 24, 2020
P3, N=120, Recruiting, Sponsor: Adare Pharmaceuticals, Inc.
- || fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion date, Trial primary completion date: FLUTE: Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (clinicaltrials.gov) - Feb 23, 2020
P2, N=106, Active, not recruiting, Sponsor: Adare Pharmaceuticals, Inc.
Abstracts will be released on Friday, October 9, 2020. Trial completion date: Aug 2019 --> Mar 2020 | Trial primary completion date: Jan 2019 --> Nov 2019
- fluticasone propionate ODT (APT-1011) / Adare Pharma
AN EPISODE-BASED, PATIENT-REPORTED OUTCOME MEASURE OF DYSPHAGIA ACCURATELY CAPTURES RESPONSE TO TREATMENT WITH APT-1011 IN A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CLINICAL TRIAL IN ADULTS WITH EOSINOPHILIC ESOPHAGITIS () - Jan 28, 2020 - Abstract #DDW2020DDW_2932;
The newly developed PROSE instrument was used to measure episodes of dysphagia and accurately captured response to treatment, showing that episodes of dysphagia decreased after treatment compared to placebo, particularly for the 3 mg QHS dose, where the reduction was also clinically meaningful. These symptom data support the use of the 3 mg QHS dose in further development of APT-1011.
- fluticasone propionate ODT (APT-1011) / Adare Pharma
AN EPISODE-BASED PATIENT-REPORTED OUTCOME MEASURE OF DYSPHAGIA EXPERIENCE IS FEASIBLE AND NOT BURDENSOME FOR PATIENTS WITH EOSINOPHILIC ESOPHAGITIS () - Jan 28, 2020 - Abstract #DDW2020DDW_2931;
Development was rigorous and in line with FDA guidance, and PROSE was shown to be reliable and valid. Use in a phase 2b study demonstrated excellent compliance, with minimal burden to patients, as it only requires minutes to complete.
- Fluticasone propionate ODT (APT-1011) / Adare Pharma
SAFETY AND EFFICACY OF 4 DOSAGE REGIMENS OF APT-1011: RESULTS FROM A PHASE 2B RANDOMIZED DOUBLE BLIND PLACEBO-CONTROLLED TRIAL TO SELECT THE BEST DOSAGE REGIMEN FOR FURTHER DEVELOPMENT. (CLINICALTRIALS.GOV NCT03191864; EUDRACT NUMBER: 2016-004749-10) (C2) - Oct 4, 2019 - Abstract #UEGW2019UEGW_4239;
P2
The 3 mg HS dose proved to have the best benefit to risk balance of efficacy and safety, with the added benefit of once daily dosing, for future development. Maintenance therapy for up to 52 Weeks is currently ongoing.
- | fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Enrollment closed, Trial completion date, Trial primary completion date: FLUTE: Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (clinicaltrials.gov) - Aug 28, 2018
P2, N=100, Active, not recruiting, Sponsor: Adare Pharmaceuticals, Inc.
Maintenance therapy for up to 52 Weeks is currently ongoing. Recruiting --> Active, not recruiting | Trial completion date: Sep 2018 --> Aug 2019 | Trial primary completion date: Sep 2018 --> Jan 2019
- | fluticasone propionate ODT (APT-1011) / Ellodi Pharma
New P2 trial: FLUTE: Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (clinicaltrials.gov) - Jun 19, 2017
P2, N=100, Recruiting, Sponsor: Adare Pharmaceuticals, Inc.
- | fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Enrollment change: A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021 (clinicaltrials.gov) - Feb 11, 2017
P1/2, N=14, Completed, Sponsor: Forest Laboratories
Recruiting --> Active, not recruiting | Trial completion date: Sep 2018 --> Aug 2019 | Trial primary completion date: Sep 2018 --> Jan 2019 N=24 --> 14
- | fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Enrollment open: A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021 (clinicaltrials.gov) - Oct 30, 2012
P1/2, N=24, Enrolling by invitation, Sponsor: Aptalis Pharma
N=24 --> 14 Not yet recruiting --> Enrolling by invitation
- | fluticasone propionate ODT (APT-1011) / Ellodi Pharma
Trial completion: Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis (clinicaltrials.gov) - Oct 30, 2012
P1/2, N=24, Completed, Sponsor: Aptalis Pharma
Not yet recruiting --> Enrolling by invitation Recruiting --> Completed
- | fluticasone propionate ODT (APT-1011) / Ellodi Pharma
New P1/2 trial: A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021 (clinicaltrials.gov) - Dec 21, 2011
P1/2, N=24, Enrolling by invitation, Sponsor: Aptalis Pharma