fluticasone propionate ODT (APT-1011) / Ellodi Pharma - LARVOL DELTA

FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects with Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - P3 | N=218 | Completed | Sponsor: Ellodi Pharmaceuticals, LP | Active, not recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Aug 2024

Trial completion • Trial completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

FLUTICASONE PROPIONATE ORAL DISINTEGRATING TABLET, APT-1011, LEADS TO A GREATER COMPLETE SYMPTOMATIC RESPONSE RATE COMPARED TO PLACEBO IN SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS (EOE) (DDW 2024) - "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."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

FLUTICASONE PROPRIONATE ORAL DISINTEGRATING TABLET, APT-1011, IMPROVES FIBROSTENOTIC FEATURES OF STRICTURES AND GRADE 2/3 RINGS IN SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS (EOE) (DDW 2024) - "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."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Inflammation

Ellodi Pharmaceuticals Announces FLUTE-2 Data to be Presented at DDW 2024 with APT-1011 in Patients with Eosinophilic Esophagitis (Businesswire) - P3 | N=143 | FLUTE-2 (NCT04281108) | Sponsor: Ellodi Pharmaceuticals, LP | "Ellodi Pharmaceuticals...announced an oral presentation by Professor Evan Dellon M.D., M.P.H, at the Digestive Disease Week (DDW) 2024 Annual Scientific Meeting. The presentation will highlight encouraging results of APT-1011 (fluticasone propionate orally disintegrating tablet) in the FLUTE-2 Phase 3 clinical study in Eosinophilic Esophagitis (EoE)....'The results of the FLUTE-2 study indicate that APT-1011 could provide symptomatic and histologic benefits and help to fulfill the unmet need in patients with EoE'....At Week 12, 26 subjects on APT-1011 (27%) vs. 5 (11%) on placebo had a complete symptom response (p=0.031). Within the cohorts of symptomatic responders, concomitant eosinophilic remission was seen in 81% of subjects in the APT-1011 arm vs. zero subjects on placebo."

P3 data • Eosinophilic Esophagitis • Immunology • Inflammation

FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - P3 | N=218 | Active, not recruiting | Sponsor: Ellodi Pharmaceuticals, LP | Recruiting ➔ Active, not recruiting

Enrollment closed • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Ellodi Pharmaceuticals, LP

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

Novel corticosteroid formulations in the treatment of eosinophilic esophagitis: what is the evidence? (PubMed, Acta Gastroenterol Belg) - "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."

Journal • Review • Eosinophilic Esophagitis • Fibrosis • Food Hypersensitivity • Gastrointestinal Disorder • Immunology • Inflammation

FLUTE-3: 24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Ellodi Pharmaceuticals, LP | Trial completion date: Oct 2025 ➔ Mar 2025

Trial completion date • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-3) (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Ellodi Pharmaceuticals, LP | Not yet recruiting ➔ Recruiting

Enrollment open • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-3) (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Ellodi Pharmaceuticals, LP

New P3 trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - P3 | N=143 | Completed | Sponsor: Ellodi Pharmaceuticals, LP | Active, not recruiting ➔ Completed

Trial completion • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

FLUTEEN: Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial (clinicaltrials.gov) - P3 | N=5 | Completed | Sponsor: Ellodi Pharmaceuticals, LP | Active, not recruiting ➔ Completed

Trial completion • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - P3 | N=143 | Active, not recruiting | Sponsor: Ellodi Pharmaceuticals, LP | Trial primary completion date: Aug 2022 ➔ May 2022

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

Update on Emerging Pharmacologic Therapies for Patients With Eosinophilic Esophagitis. (PubMed, Gastroenterol Hepatol (N Y)) - "Some newer topical corticosteroid preparations are being studied, including a budesonide suspension (TAK-721), orodispersible tablet formulations of budesonide and fluticasone (APT-1011), and mometasone and ciclesonide preparations. Also in various stages of clinical trials are potential disease-modifying biologics such as dupilumab, cendakimab, lirentelimab, benralizumab, and mepolizumab. 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."

Journal • Eosinophilic Esophagitis • Gastroenterology • Gastrointestinal Disorder • Immunology

Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - P3 | N=143 | Active, not recruiting | Sponsor: Ellodi Pharmaceuticals, LP | Trial primary completion date: Jul 2021 ➔ May 2022

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

FLUTEEN: Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial (clinicaltrials.gov) - P3 | N=5 | Active, not recruiting | Sponsor: Ellodi Pharmaceuticals, LP | Recruiting ➔ Active, not recruiting | N=30 ➔ 5

Enrollment change • Enrollment closed • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) for Eosinophilic Esophagitis: Randomized Controlled Trial. (PubMed, Clin Gastroenterol Hepatol) - 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, 3mg once daily at bedtime dose showed the most favorable risk-benefit profile. ClinicalTrials.gov, number NCT03191864."

Clinical • Journal • Candidiasis • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

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 (ACG 2021) - "At total of 103 patients were enrolled (mean age 38.6; 68.0% male; 97.1% white). 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."

Clinical • P2b data • Retrospective data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

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 (ACG 2021) - "106 adults meeting selection criteria were randomized to 1 of 4 doses of APT 1011 (1.5mg HS, 1.5mg BID, 3mg HS, and 3mg BID) or placebo. 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)."

Clinical • P2b data • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pain

Expanded Access Protocol for Patients With Eosinophilic Esophagitis (clinicaltrials.gov) - P=N/A; N=N/A; Available; Sponsor: Ellodi Pharmaceuticals, LP

Clinical • New trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

FLUTEEN: Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial (clinicaltrials.gov) - P3; N=30; Recruiting; Sponsor: Ellodi Pharmaceuticals, LP

Clinical • New P3 trial • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (clinicaltrials.gov) - P3; N=143; Active, not recruiting; Sponsor: Ellodi Pharmaceuticals, LP; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology

[VIRTUAL] COMPLIANCE FOR THE PROSE DAILY DIARY: MEASURING COMPLETION RATES OF A NEW INSTRUMENT TO MEASURE DYSPHAGIA EPISODES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS (UEGW 2021) - "Aims & The FLUTE trial was a phase 2b, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study of APT-1011, a novel fluticasone propionate orally disintegrating tablet, vs placebo in adults with EoE... The PROSE is an electronic daily diary available on a hand-held device with which patients can self-report on their episodes of dysphagia in real-time and at end of day. 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."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pain

[VIRTUAL] COMPLIANCE FOR THE PROSE DAILY DIARY: MEASURING COMPLETION RATES OF A NEW INSTRUMENT TO MEASURE DYSPHAGIA EPISODES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS (UEGW 2021) - "Aims & The FLUTE trial was a phase 2b, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study of APT-1011, a novel fluticasone propionate orally disintegrating tablet, vs placebo in adults with EoE... The PROSE is an electronic daily diary available on a hand-held device with which patients can self-report on their episodes of dysphagia in real-time and at end of day. 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."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pain

[VIRTUAL] COMPLIANCE FOR THE PROSE DAILY DIARY: MEASURING COMPLETION RATES OF A NEW INSTRUMENT TO MEASURE DYSPHAGIA EPISODES IN PATIENTS WITH EOSINOPHILIC ESOPHAGITIS (UEGW 2021) - "Aims & The FLUTE trial was a phase 2b, randomized, double-blind, placebo-controlled, multicenter, dose-ranging study of APT-1011, a novel fluticasone propionate orally disintegrating tablet, vs placebo in adults with EoE... The PROSE is an electronic daily diary available on a hand-held device with which patients can self-report on their episodes of dysphagia in real-time and at end of day. 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."

Clinical • Eosinophilic Esophagitis • Gastrointestinal Disorder • Immunology • Pain