HTD4010: Alcoholic Hepatitis (AH)

Alcoholic hepatitis (AH) is an acute, life-threatening disease caused by chronic heavy alcohol use or a drastic increase in alcohol consumption. It is characterized by severe inflammation and, ultimately, liver failure and death.  In USA, more than 137,000 people are hospitalized with AH each year and the average 28-day mortality rate is 26 percent.

Currently, there is no approved treatment for AH, and few drugs are in development. The current standard of care focuses on abstinence, treating inflammation, and providing nutrition, which is often inadequate in moderate and severe patients.  Corticosteroid therapy and liver transplantation are treatment options for severe alcoholic hepatitis (SAH).

How HTD4010 Could Help in AH?

HTD4010 is a 15-amino acid long synthetic peptide homologous to an active peptide sequence found within the human RegIIIα protein (PAP).

Beneficial effects of HTD4010 in AH are expected to include:

For Severe AH patients:

Replace corticosteroids as first-line therapy.
Second-line therapy for patients not eligible for/not respond to corticosteroids, or not cured after 28-day corticosteroids.

For Moderate AH patients:

Potential novel therapy to treat and to prevent transition to SAH.

Market Overview

AH is an advanced form of ALD with different severity levels. The number and prevalence of ALD patients in China, US and Europe are 62 million (4.50%), 19 million (6.20%) and 31 million (6.00%), respectively.

True prevalence of AH is not well known, as its presence is commonly overlooked in patients with decompensated ALD.1

~137,000 U.S. hospitalizations per year for AH.2

AH hospitalizations increased by approximately 4.8% per year between 2015 and 2018.3

According to “Alcoholic Hepatitis Treatment Market by Type and Geography - Forecast and Analysis 2021-2025” report by Technavio, the global AH treatment market is poised to grow by $695.42 million during 2021-2025, progressing at a CAGR of over 6% during the forecast period.

1. The American journal of gastroenterology vol. 113,2 (2018): 175-194.
3. Marlowe,, AASLD 2021 Poster No. 381



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