Challenged Benitec moves to get word out on hep B candidate

Benitec CFO and interim CEO Greg West

Sydney-based Benitec Biopharma ($BNTC) has moved quickly to get word out on its hepatitis B candidate, weeks after saying it would wind up a Phase I/IIa clinical trial for hepatitis C candidate TT-034 as commercial prospects waned.

The dual-listed firm, in Australia and the U.S., said in a release that in-development candidate BB-HB-331 to treat hepatitis B showed the "DNA-directed RNA interference (ddRNAi) therapy targeting the hepatitis B virus (HBV), demonstrates robust and durable suppression of HBV in vivo following a single administration."

The company needs some good news as it searches for a new CEO and its stock languishes following the TT-034 announcement in February.

At the time, the firm said it was important to marshal its resources on the pipeline of the hepatitis B therapy, age-related macular degeneration and oculopharyngeal muscular dystrophy. It specified that it would prioritize the hepatitis B program as its next candidate for clinical development.

"The company believes that each of these programs presents attractive commercial opportunities," Benitec said in February, adding the "hepatitis B program is attracting considerable interest from pharmaceutical companies."

In July last year, Benitec bought the rights to the preclinical ddRNAi-based hepatitis B therapeutic program, Hepbarna, from China-based partner Biomics Biotechnologies.

Benitec paid Biomics A$2.5 million, with an additional A$3.5 million possible on successful commercialization of the program, which was previously a joint venture. Biomics will receive a single-digit royalty on net sales if the product is marketed.

"Over the past 12 months, Benitec has advanced the program significantly, and based on promising in vitro data, has taken the decision to develop Hepbarna as a solely owned lead program by acquiring Biomics' share," the company said in a July 9, 2015, press release.

In an update, Benitec said the "current in vivo study assessed the activity of BB-HB-331 in the PhoenixBio (PXB) mouse model, in which mouse liver cells have been replaced with human hepatocytes making the animals susceptible to HBV infection."

"Once infected with HBV, mice were treated with a one-time systemic injection of BB-HB-331. Weekly assessment of serum antigen levels, HBV viral proteins and extracellular HBV DNA were conducted for the duration of the 56-day study."

- here's the release

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