First Wave Bio
Entero Therapeutics is a clinical stage biopharmaceutical company specializing in the development of targeted, orally delivered therapies for gastrointestinal (GI) diseases. Their mission is to develop innovative treatments for GI disorders with significant unmet needs, aiming to improve patient health and quality of life. Their vision is to bring first-in-class therapies to market that address the root causes of GI diseases, including celiac disease, gastroparesis, exocrine pancreatic insufficiency, and inflammatory bowel diseases.
Industries
Nr. of Employees
small (1-50)
First Wave Bio
777 Yamato Road, Suite 502, Boca Raton, FL 33431
Products
Oral recombinant gluten-degrading protease therapy
An orally administered recombinant protease combination developed to degrade dietary gluten proteins in the gastrointestinal tract as an adjunct to a gluten-restricted diet for celiac disease.
Selective 5-HT4 receptor partial agonist for GI motility (repurposed)
A selective 5-HT4 receptor partial agonist being evaluated for promotion of gastrointestinal motility and potential epithelial effects in motility and inflammatory GI indications.
Recombinant yeast-derived lipase for exocrine pancreatic insufficiency
An orally administered recombinant lipase produced in yeast and formulated for enteric protection to hydrolyze dietary fats in the digestive tract for patients with exocrine pancreatic insufficiency.
Repurposed niclosamide-based localized GI formulations
Repurposed small-molecule formulations of niclosamide developed for oral or topical localized delivery to treat distal ulcerative colitis variants, certain GI infections, and selected inflammatory conditions.
Oral recombinant gluten-degrading protease therapy
An orally administered recombinant protease combination developed to degrade dietary gluten proteins in the gastrointestinal tract as an adjunct to a gluten-restricted diet for celiac disease.
Selective 5-HT4 receptor partial agonist for GI motility (repurposed)
A selective 5-HT4 receptor partial agonist being evaluated for promotion of gastrointestinal motility and potential epithelial effects in motility and inflammatory GI indications.
Recombinant yeast-derived lipase for exocrine pancreatic insufficiency
An orally administered recombinant lipase produced in yeast and formulated for enteric protection to hydrolyze dietary fats in the digestive tract for patients with exocrine pancreatic insufficiency.
Repurposed niclosamide-based localized GI formulations
Repurposed small-molecule formulations of niclosamide developed for oral or topical localized delivery to treat distal ulcerative colitis variants, certain GI infections, and selected inflammatory conditions.
Services
End-to-end clinical program support including protocol design, Phase 1–3 study execution, investigator-sponsored and company-run trials, CRO oversight, and clinical data analysis.
Development of enteric-protected oral formulations (microgranules, spray-dried dispersions) and coordination with contract manufacturers and packaging partners for clinical supply and scale-up planning.
Identification and execution of licensing deals, in-licensing of development-stage assets, and execution of mergers or acquisitions to expand therapeutic pipeline.
Development and filing of patent strategies and provisional/utility patent applications related to biologic therapeutics and formulation technologies.
End-to-end clinical program support including protocol design, Phase 1–3 study execution, investigator-sponsored and company-run trials, CRO oversight, and clinical data analysis.
Development of enteric-protected oral formulations (microgranules, spray-dried dispersions) and coordination with contract manufacturers and packaging partners for clinical supply and scale-up planning.
Identification and execution of licensing deals, in-licensing of development-stage assets, and execution of mergers or acquisitions to expand therapeutic pipeline.
Development and filing of patent strategies and provisional/utility patent applications related to biologic therapeutics and formulation technologies.
Expertise Areas
- Clinical trial management
- Recombinant enzyme therapeutics
- Oral enteric drug delivery
- Exocrine pancreatic insufficiency therapeutics
Key Technologies
- Recombinant protease therapeutics
- Yeast-based recombinant enzyme expression
- Enteric-coated microgranule formulations
- Spray-dried dispersion enteric technologies
News & Updates
Multiple interviews and media appearances by James Sapirstein in 2024, including on The Big Biz Show, BioTuesdays, and Benzinga, discussing the company's progress, clinical trials, and strategic partnerships.
This acquisition aims to strengthen the company's pipeline in GI diseases.
Multiple interviews and media appearances by James Sapirstein in 2024, including on The Big Biz Show, BioTuesdays, and Benzinga, discussing the company's progress, clinical trials, and strategic partnerships.
This acquisition aims to strengthen the company's pipeline in GI diseases.