Benitec cleared for first-in-[hu]man hep C trial

By Dylan Bushell-Embling
Wednesday, 15 January, 2014

Benitec Biopharma (ASX:BLT) has been granted approval to proceed with a first-in-[hu]man trial of its single-injection hepatitis C treatment candidate TT-034.

The US FDA has advised Benitec that it can conduct the trial, after reviewing the Investigational New Drug (IND) application the company filed in early December.

“We are very pleased with this outcome, which establishes Benitec as a clinical-stage company,” Benitec Biopharma CEO Peter French said.

TT-034 is a therapeutic designed to treat hepatitis C with a single injection. It is based on gene-silencing technology known as DNA-directed RNA interference (ddRNAi), originally developed at the CSIRO and then exclusively licensed to Benitec.

The treatment itself was developed by US-based Tacere Therapeutics, which took out a licence to the ddRNAi technology from Benitec in 2006.

Benitec acquired Tacere and TT-034 in 2012 through an all-stock deal worth around $1.5 million before licensing fees

The global market for hepatitis-based treatments is estimated at $6.5 billion, and is expected to more than double in value by 2015.

Benitec Biopharma (ASX:BLT) shares were trading 8.7% higher at $0.75 as of around 12.30 pm on Wednesday.

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