# Development of TP-352 for the Treatment of Pediatric Non-alcoholic Steatohepatitis

> **NIH NIH R44** · THETIS PHARMACEUTICALS, LLC · 2020 · $1,982,861

## Abstract

ABSTRACT
 Non-alcoholic fatty liver disease (NAFLD) refers to a spectrum of diseases related to metabolic
syndrome that are characterized by steatosis, the accumulation of fat within the liver. Non-alcoholic
steatohepatitis (NASH), the most aggressive NAFLD subtype, refers to the presence of inflammation and
necrosis in a background of steatosis, and is associated with hepatic fibrosis. NASH is a serious health
problem that can lead to serious long-term health issues, including liver fibrosis, cirrhosis and hepatocellular
carcinoma. In the last few decades, NASH has emerged as one of the most common liver disorders amongst
pediatric and adolescent patients. Despite affecting approximately two million children in the United States,
there are currently no approved therapies for NASH.
 To answer this unmet medical need, Thetis Pharmaceuticals (Thetis) proposes to develop magnesium
L-lysinate bis docosahexaenoate, or TP-352, as a safe, oral therapy for resolution of NASH in pediatric
patients. TP-352 delivers docosahexaenoic acid, (DHA), an Omega-3 polyunsaturated fatty acid (PUFA)
shown to have clinical efficacy for treatment of pediatric NASH. TP-352 overcomes the physico-chemical and
commercial deficits inherent to DHA to enable development of a safe and effective treatment for NASH.
 In this SBIR Fast-Track project, Thetis will complete the preclinical activities required for an
investigational new drug (IND) submission to the FDA and initiation of clinical studies. This goal will be
achieved through the execution of five Specific Aims. The objective of Phase I is to obtain initial proof of
concept by performing an efficacy studies using an established mouse model of NASH (Specific
Aim #1) and characterizing TP-352 pharmacokinetics in mice (Specific Aim #2). The objective of Phase II is to
complete key commercially-enabling preclinical activities required to initiate clinical studies. Initial efforts will
focus on conducting a toxicological program (Specific Aim #3). Once the efficacy and acceptable toxicity
profile of TP-352 are demonstrated, Thetis will manufacture good manufacturing practice (GMP) certified
clinical trial material for the Phase 1 program (Specific Aim #4). Upon completion of this Fast-Track SBIR
project, Thetis will have completed all requisite studies to submit an IND application and initiate Phase 1
clinical studies. As indicated by letters of support from some of the country’s leading NASH specialists, this
SBIR project is critical to enabling development of the TP-352 program to address the unmet medical need in
this vulnerable pediatric population.

## Key facts

- **NIH application ID:** 10005537
- **Project number:** 4R44DK121612-02
- **Recipient organization:** THETIS PHARMACEUTICALS, LLC
- **Principal Investigator:** Frank Sciavolino
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,982,861
- **Award type:** 4N
- **Project period:** 2019-09-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10005537

## Citation

> US National Institutes of Health, RePORTER application 10005537, Development of TP-352 for the Treatment of Pediatric Non-alcoholic Steatohepatitis (4R44DK121612-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10005537. Licensed CC0.

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