Ellodi Pharma to Present FLUTE-2 Data on APT-1011 at DDW 2024 for Eosinophilic Esophagitis

Ellodi Pharmaceuticals, a company dedicated to gastroenterology, has shared promising results about its drug APT-1011 for treating Eosinophilic Esophagitis (EoE). At the 2024 Digestive Disease Week (DDW) Annual Scientific Meeting, Professor Evan Dellon, the primary investigator of the FLUTE-2 Phase 3 clinical study, will present these findings. The presentation is set for May 21 at 8am ET, under the title "Fluticasone Propionate Orally Disintegrating Tablet (APT-1011) Leads to a Greater Complete Symptomatic Response Rate and Improved Fibrostenotic Features of Strictures and Grade 2/3 Rings Compared to Placebo in Subjects with Eosinophilic Esophagitis (EoE): Results from the FLUTE-2 Trial." It will be a part of the session "Advances in Diagnosis and Management of Eosinophilic Esophagitis."

EoE is a chronic, often debilitating disease with increasing incidence. Current therapies have not kept pace with the growing number of patients, highlighting an urgent need for new FDA-approved treatments. The FLUTE-2 study suggests that APT-1011 can provide both symptomatic and histologic benefits, thus addressing this unmet medical need. Prof. Dellon expressed optimism regarding the continued development of APT-1011 through its Phase 3 program.

Dr. Gina Eagle, Vice President and Global Head of Research and Development at Ellodi Pharmaceuticals, emphasized the company's commitment to improving the lives of patients suffering from EoE. She mentioned that the post hoc results of the FLUTE-2 study are particularly encouraging and looked forward to sharing more data on APT-1011 later in the year.

APT-1011, a fluticasone propionate orally disintegrating tablet, was tested in a randomized trial involving 143 subjects (97 on APT-1011 and 46 on placebo). The study yielded several key findings:

1. Complete Symptomatic Response: At the 12-week mark, 27% of patients on APT-1011 experienced zero dysphagia days over 14 consecutive days, compared to just 11% of those on placebo. Additionally, 81% of symptomatic responders in the APT-1011 group showed eosinophilic remission, while no such remission was observed in the placebo group.

2. Improvement in Fibrostenotic Features: Of the 143 subjects, 34 had strictures and 48 had grade 2/3 rings. APT-1011 demonstrated a significantly higher rate of stricture resolution or improvement in grade 2/3 rings compared to placebo (58.5% vs 25.0%) at 12 weeks. These improvements were sustained over longer durations (up to 38 and 52 weeks).

The treatment with APT-1011 was generally safe and well-tolerated. Adverse events were similar between the treatment groups, with the exception of local candidiasis, which did not necessitate treatment interruption. Importantly, there were no reports of adrenal suppression.

APT-1011 is designed to deliver fluticasone propionate directly to the esophageal mucosa, exerting local anti-inflammatory effects with minimal systemic absorption. Following the successful completion of the FLUTE 1 (Phase 2b study) and FLUTE-2 (Phase 3 study), the FLUTE 3 (another Phase 3 study) is currently underway. APT-1011 has received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA), as well as Fast Track Designation from the FDA in 2021. 

Ellodi Pharmaceuticals remains focused on its mission to develop innovative therapies for gastrointestinal disorders and rare diseases. With a dedicated team of experts, the company continues to push forward in its efforts to bring effective treatments to patients in need.

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