Dual-listed Benitec to scrap hep C trials as commercial prospects dim

Sydney-based biotech Benitec Biopharma ($BNTC) will scrap a Phase I/IIa clinical trial for hepatitis C candidate TT-034, citing dim commercial prospects in a crowded space as existing players improve products and new ones reach the market.

Benitec CFO and interim CEO Greg West

On the release of the announcement, Benitec plunged more than 61% to a record low on the Australia Stock Exchange Friday. The company is also listed on the Nasdaq where its American Depositary Receipts (ADRs) were last quoted at $3.50 a share. It listed on the U.S. exchange at $9.21 per ADR in September of last year.

As recently as September last year, Benitec had added a clinical site in Texas for the trial of TT-034 aimed at treating hepatitis C by reducing its viral load.

The other trial sites are the Duke Clinical Research Institute, the University of California, San Diego, and the Texas Liver Institute, the company said in the release.

But by December, the firm had named an interim CEO Greg West, after the abrupt departure of CEO Peter French in a move the company said on a conference call was aimed at finding a CEO who could bring deep experience in the U.S. market.

In a release, Benitec said the hep C candidate had captured limited partnership interest and that the financial hit would not impact other candidates under development.

In October 2005, Sigma-Aldrich agreed to pay about $4.5 million for an equity stake and technology license with Benitec.

The company touts its approach to RNA interference, known as DNA-directed RNAi.

The current trial will end with the completion of patients in the Cohort 4 segment, according to the release.

"Benitec's board made the decision to discontinue the hepatitis C program following a review of the commercial opportunities for TT-034," the company said in a statement.

"A number of effective therapies have become available for the treatment of hepatitis C since Benitec commenced its clinical trial in January 2014. In recent months, several competitors have made improvements in the efficacy, delivery and success rates of their product treatments while continuing to reduce pricing and treatment duration."

The company said its pipeline to continue includes candidates in hepatitis B therapy, age-related macular degeneration and oculopharyngeal muscular dystrophy.

"The company believes that each of these programs presents attractive commercial opportunities," according to the statement.

"In particular, the hepatitis B program is attracting considerable interest from pharmaceutical companies. Based on this interest and anticipated in vivo data, combined with a significant potential market opportunity, Benitec will now prioritize the hepatitis B program as its next candidate for clinical development."

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

- here's the release