Ellodi Pharmaceuticals Announces FLUTE-2 Data to be Presented at DDW 2024 with APT-1011 in Patients with Eosinophilic Esophagitis

• APT-1011 Demonstrated a Higher Rate of Complete Symptomatic Response at 12-Weeks Compared to Placebo
• APT-1011 Demonstrated Improvement in Fibrostenotic Features and Grade 2/3 Rings at 12 weeks and maintained improvements at longer durations (up to 38 and 52 weeks)

BLUE BELL, Pa.--(BUSINESS WIRE)-- Ellodi Pharmaceuticals, a gastroenterology-focused specialty pharmaceutical company, today 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).

Dr. Dellon, who served as the Primary Investigator for FLUTE-2, will present the data on Tuesday, May 21 at 8am ET. The presentation, titled, 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, will be a podium presentation at the DDW Meeting and will take place during the session “Advances in Diagnosis and Management of Eosinophilic Esophagitis.”

“The rapid rise in the incidence and prevalence of EoE has outpaced the development of EoE-specific therapies, creating a significant unmet medical need for additional effective FDA approved treatments. 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. I look forward to the continued development APT-1011 through its Phase 3 program,” said Prof. Dellon.

“We are focused on making a difference for patients suffering from EoE. We are particularly encouraged by the post hoc results of the FLUTE-2 study and look forward to sharing future data on APT-1011 in the second half of the year. These data will support the potential opportunity to bring a new treatment option to patients suffering from this chronic and often debilitating disease,” said Dr. Gina Eagle, Vice President and Global Head of Research and Development at Ellodi Pharmaceuticals.

Additional Information

The presentation includes two abstracts (#964- 965):

Abstract 1: Fluticasone Propionate Orally Disintegrating Tablet, APT-1011, Leads to a Greater Complete Symptomatic Response Rate Compared to Placebo in Subjects with Eosinophilic Esophagitis (EoE)

• A total of 143 subjects were randomized (97 APT-1011; 46 placebo) into Part A.
• Complete symptom response was measured as zero dysphagia days over 14 consecutive days.
• 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.

Abstract 2: Fluticasone Propionate Orally Disintegrating Tablet, APT-1011, Improves Fibrostenotic Features of Strictures and Grade 2/3 Rings in Subjects with Eosinophilic Esophagitis (EoE)

• Of 143 subjects randomized (97 APT-1011; 46 placebo), 34 had strictures, 48 had grade 2/3 rings, 61 had either and 21 had both, at baseline.
• APT-1011 showed a higher rate of resolution of stricture or improvement of grade 2/3 rings as compared to placebo after 12 weeks (58.5% vs 25.0%; p=0.015).
• Longer durations of APT-1011 (up to 38 or 52 weeks) showed similar results with sustained improvement in most subjects.

Treatment with APT-1011 in patients with EoE was generally safe and well tolerated. Adverse events were comparable between treatment arms, with the exception of local candidiasis that did not necessitate treatment interruption. There were no reports of adrenal suppression.

About APT-1011

APT-1011 is a novel, once daily, orally disintegrating tablet designed specifically to deliver fluticasone propionate to the esophageal mucosa to exert local anti-inflammatory effects with low systemic absorption. The successful completion of FLUTE 1 (Phase 2b study) and FLUTE-2 (Phase 3 study) has facilitated the initiation of FLUTE 3 (ongoing second Phase 3 study - www.ellodipharma.com/flute3study). APT-1011 has received Orphan Drug Designation from the FDA and the European Medicines Agency (EMA), and also received Fast Track Designation from the FDA in 2021. This designation was granted based on data evaluating histological remission and symptomatic improvement after 12 weeks (induction) and 52 weeks of treatment. More information about APT-1011 can be found at www.ellodipharma.com.

About Ellodi Pharmaceuticals

Ellodi Pharmaceuticals is a gastroenterology-focused specialty pharmaceutical company dedicated to the development of APT-1011, a novel, investigational oral therapy for the treatment of Eosinophilic Esophagitis (EoE). Ellodi Pharmaceuticals has assembled a seasoned team with deep expertise in developing and commercializing innovative therapies for gastrointestinal disorders and rare diseases. Further information about Ellodi Pharmaceuticals can be found at www.ellodipharma.com.

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