Q2 2024 | NASDAQ: ENTO |
Targeted Therapies for Gastrointestinal Diseases
Corporate Overview
Entero Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
The company is currently advancing a therapeutic development pipeline with multiple late-stage clinical programs built around three proprietary technologies: latiglutenase, a Phase 3-ready, potentially first-in-class, targeted, oral biotherapeutic for celiac disease; capeserod, a selective 5- HT4 receptor partial agonist being developed for gastroparesis; and adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency.
Clinical Pipeline
Product/Indication
LATIGLUTENASE
Celiac Disease
CAPESEROD
Gastroparesis
ADRULIPASE
Exocrine Pancreatic Insufficiency Monotherapy
Exocrine Pancreatic Insufficiency Combination w/ PERT
Technologies
Latiglutenase
Pre-IND | Phase 1 | Phase 2 | Phase 3 |
Phase 3 Ready
Phase 2 Anticipated
Phase 2b Completed
Phase 2a Completed
CapeserodAdrulipase
Orally administered, Phase 3 ready, recombinant digestive enzyme therapy to treat celiac disease
- Acquired from ImmunogenX in Mar. 2024
- Demonstrated effectiveness in alleviating symptoms of celiac disease in two Phase 2 trials
Re-purposed selective 5-HT4 receptor partial agonist for gastrointestinal indications
- In-licensedfrom Sanofi in Sept. 2023
- Unique mechanism of action applicable to several GI indications
- Gastroparesis
- Pediatric Ulcerative Colitis
- Constipation
Recombinant lipase enzyme administered as an oral, non- systemic biologic capsule for the treatment of EPI
- Non-porcinerecombinant alternative
- Designed as a potential improvement over PERT
- PERT can require upwards of 40 pills per day
www.enterothera.com | Entero Therapeutics, Inc. - 777 Yamato Road, Suite 502, Boca Raton, FL 33431 |
Q2 2024 | NASDAQ: ENTO |
Targeted Therapies for Gastrointestinal Diseases
Therapeutic Indications
Celiac Disease
- Celiac disease (CeD) is an autoimmune disorder of the small intestine resulting from intolerance to gluten proteins, afflicting nearly 1% of most population (~3.3 million patients in the U.S.)
- The principal physiology is villous atrophy in the small intestinal epithelium triggered by the ingestion of cereal grains, such as wheat, rye, or barley
- CeD has no known cure and the only effective therapy is adherence to a lifelong gluten-free diet
Gastroparesis
- Gastroparesis is the delayed movement of food from the stomach to the small intestine, not caused by blockage. Symptoms include feeling full soon after starting a meal or long after completing one, as well as nausea, and vomiting.
- Gastroparesis impacts approximately 50 in 100,000 people and is more common in women
Exocrine Pancreatic Insufficiency (EPI) in Cystic Fibrosis
- EPI affects 40,000 cystic fibrosis patients and 95,000 chronic pancreatitis patients in the U.S.
- High daily PERT pill burden with CF patients currently taking 25 to 40 capsules daily to control symptoms; safety concerns with black box warnings for PERT therapy (risks of fibrosing colonopathy and transmission of animal pathogens)
Clinical Development Plans & Milestones
Product | Indication | 2023 | 2024 | 2025 | 2026 | 2027 | ||
Latiglutenase | Celiac disease | Phase 3 Dosing | Phase 3 | BLA | ||||
Safety | ||||||||
Capeserod
Gastroparesis
Phase 2*
Adrulipase
EPI in CF, CP
Phase 2b
*Subject to FDA IND review
Executive Management Team | Investor / Media Contacts | |
info@enterothera.com | ||
James Sapirstein | Chairman and CEO | |
Russo Partners | ||
Jack Syage, Ph.D. | President and CSO | David Schull/Liz Phillips (media) |
Sarah Romano | Chief Financial Officer | +1 (347) 956-7697 |
david.schull@russo.com | ||
Martin Krusin | SVP, Corporate Development | elizabeth.phillips@russo.com |
www.enterothera.com | Entero Therapeutics, Inc. - 777 Yamato Road, Suite 502, Boca Raton, FL 33431 |
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Entero Therapeutics Inc. published this content on 07 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 June 2024 13:40:06 UTC.