Ellodi Pharmaceuticals Announces FLUTE-2 Data to be Presented at DDW 2024 with APT-1011 in Patients with Eosinophilic Esophagitis
2024年5月21日 - 7:00PM
ビジネスワイヤ(英語)
- 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)
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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Sarah Murchison sarah.murchison@ellodipharma.com