# Development of an Oral Pill to Mimic the Effects of Gastric Bypass Surgery

> **NIH NIH R44** · SYNTIS BIO INC · 2024 · $322,787

## Abstract

PROJECT SUMMARY
Obesity is a complex disease that disrupts hormonal and metabolic pathways, increasing the risk of chronic co-
morbidities like diabetes, cardiovascular disease, and cancer. Obesity itself afflicts more than 1 billion globally
and, when combined with its associated risk factors, contributes to over $480 billion in direct annual healthcare
spending. Roux en Y Gastric bypass surgery (RYGB) leverages duodenal nutrient exclusion (DNE) to achieve
best-in-class weight loss results; however, the high costs, extensive procedural risks, and limited reimbursement
have greatly limited access to care. Further, pharmacotherapies and weight loss devices have failed to strike a
balance between affordability and efficacy, which has both limited adoption and widened socioeconomic access
disparities. As such, there is a pressing need to develop novel weight loss interventions that can achieve best-
in-class results while maintaining attractive safety and cost profiles. Using technology licensed from MIT, Syntis
Bio has created a gastrointestinal synthetic epithelial lining (GSEL) that is administered orally and leverages
endogenous enzymes to form a robust muco-adhesive coating specific to the duodenal epithelium. When co-
formulated with cross-linking nanoparticles, GSEL creates a semi-permeable barrier capable of blocking nutrient
absorption (GSEL-Barrier). The goal of this proposed project is to create a once-daily oral pill that blocks nutrient
absorption in the duodenum, thereby mimicking the effects of RYGB. Thus far, GSEL-Barrier has demonstrated
the ability to reduce glucose absorption by 70% in pigs when challenged with an oral glucose tolerance test
(OGTT). In this Fast-Track SBIR proposal, we seek to expand on this this early pig work to further optimize GSEL
composition for barrier formation, engineer GSEL into solid tablet formulations, and test efficacy in beagles which
more closely reflect human gastric emptying times. Successful completion of these aims will yield optimized solid
dosage form tablets that have been validated in large animals and are ready for first-in-human testing. Syntis
will then be ready to start scaling GMP manufacturing as well as initiate GLP pre-IDE studies in preparation for
first-in-human trials.

## Key facts

- **NIH application ID:** 11005815
- **Project number:** 1R44DK141341-01
- **Recipient organization:** SYNTIS BIO INC
- **Principal Investigator:** Vasu V Sethuraman
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $322,787
- **Award type:** 1
- **Project period:** 2024-09-15 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11005815

## Citation

> US National Institutes of Health, RePORTER application 11005815, Development of an Oral Pill to Mimic the Effects of Gastric Bypass Surgery (1R44DK141341-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/11005815. Licensed CC0.

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