# Pilot Trial UO1 DUR-928

> **NIH NIH U01** · UNIVERSITY OF LOUISVILLE · 2022 · $67,470

## Abstract

AH is an acute form of alcoholic liver disease and includes a spectrum that ranges from mild injury to severe,
life threatening injury. The prevalence of AH has not been accurately determined; it is believed to occur in 10%
to 35% of heavy drinkers. On histology, AH is characterized by infiltration of the liver by inflammatory cells and
hepatocellular injury. AH is usually associated with progressive fibrosis in the presence of continued alcohol
abuse. No new drugs for AH have been successfully developed since the introduction of corticosteroids as a
treatment in the early 1970s. Corticosteroids have been utilized as a standard of care in various treatment
guidelines for patients with severe AH. Pentoxifylline has also been used because of its safety, but several
well-conducted studies have not supported the efficacy of pentoxifylline for the treatment of severe AH.
Importantly, a recent study has questioned the efficacy of both prednisone and pentoxifylline in the treatment of
AH. Mortality at 6 months was similar in patients on either prednisone, pentoxifylline, or both as compared with
placebo. Therefore, there is a need for novel therapies. DUR-928 is an endogenous intracellular regulatory
molecule and sulfated oxysterol: 5-cholesten-3β, 25-diol 3-sulfate (25HC3S). DUR-928 is under development
for multiple indications including treatment of chronic metabolic disease, such as NAFLD/NASH and PSC, and
treatment of acute organ injuries, such as AKI and AH. DUR-928 is able to lower intracellular lipid
accumulation, regulate inflammatory responses, and improve cell survival. Based on the current accumulated
knowledge of DUR-928 biology, we believe that DUR-928 represents a novel therapeutic agent for AH with an
excellent safety profile (is produced endogenously). In this PILOT UO1, we propose 2 independent, but linked
studies.
Study #1: An open-label, dose escalation study to assess the safety, pharmacokinetics and efficacy of DUR-
928 in patients with Moderate Alcoholic Hepatitis.
Study #2: An open-label, dose escalation study to assess the safety, pharmacokinetics and efficacy of DUR-
928 in patients with Severe Alcoholic Hepatitis.

## Key facts

- **NIH application ID:** 10441277
- **Project number:** 5U01AA026934-05
- **Recipient organization:** UNIVERSITY OF LOUISVILLE
- **Principal Investigator:** CRAIG J. MCCLAIN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $67,470
- **Award type:** 5
- **Project period:** 2018-09-25 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10441277

## Citation

> US National Institutes of Health, RePORTER application 10441277, Pilot Trial UO1 DUR-928 (5U01AA026934-05). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10441277. Licensed CC0.

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