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Division of Microbiology and Infectious Diseases (DMID)

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Novel Therapeutic for Hepatitis B: SB 44

TEM revealing hepatitis B virions
A digitally-colorized transmission electron micrograph (TEM) revealing the presence of hepatitis B virions. Credit: Centers for Disease Control and Prevention

An estimated 350 million people worldwide have chronic hepatitis B virus (HBV) infections. This virus causes irritation and inflammation of the liver, and those who develop chronic HBV are at risk for other serious issues such as cirrhosis and liver cancer. While acute cases frequently resolve without treatment, chronic cases can be treated to reduce the risk of complications. Unfortunately, HBV infections are becoming increasingly resistant to current available therapies and these therapies are often poorly tolerated by patients. To address these issues, NIAID supported the development of an antiviral with a novel mechanism of action against the virus. After successful preclinical studies, this new oral drug, now called SB 44, may soon be moving into clinical trials to test its effectiveness in humans for the treatment of chronic HBV infections.

NIAID Supports Testing of SB44

Spring Bank Pharmaceuticals, Inc., utilized several different resources in NIAID/DMID’s Preclinical Services Program to test this novel therapeutic. The parent drug, SB 40, first went through in vitro screening and was found to be effective against HBV. Next, SB 40 was tested in the NIAID-supported HBV transgenic mouse model to determine dose range, bioavailability and pharmacokinetics, tissue distribution, and toxicity. Results from these studies helped refine the drug, now called SB 44, so that it can be moved forward in development. In 2011, the company received a grant from NIAID to support the advancement of this therapeutic.

Progressing Toward Clinical Trials

Spring Bank Pharmaceuticals, Inc., plans to develop SB 44 through IND-enabling studies and clinical trials. NIAID/DMID’s in vitro screening program has also shown that the compound is active against hepatitis C virus infections, and the company is pursuing further studies in this area as well.

Last Updated March 19, 2013