Tacere Therapeutics is prepared to file an investigational new drug application for an expressed RNAi treatment for hepatitis C, but is looking to partner the program before doing so after previous collaborator Pfizer pulled back on its in-house RNAi drug efforts, according to Benitec.
The HCV program originally belonged to Benitec, but was licensed to Tacere in 2006 (GSN 10/12/2006). Tacere was founded by former members of Benitec's management team, which left the company when it restructured as a much smaller firm under the weight of a cash crunch.
In early 2008, Pfizer partnered with Tacere on the drug candidate, called TT-034 (GSN 1/10/2008), but that alliance ran aground a few years later when Pfizer halted its internal oligonucleotide drug-development efforts (GSN 2/10/2011).
Although neither Pfizer nor Tacere publicly stated that the partnership had been terminated, early last year Tacere President and CFO Mike Catelani told Gene Silencing News that the arrangement was up in the air (GSN 2/10/2011).
This week, Benitec said in a presentation to investors that David Suhy, Tacere's director of research and development, indicated that an IND for TT-034 is being prepared and that “a substantial portion of clinical trial material has been manufactured.”
Following “advanced discussions” with the US Food and Drug Administration, it appears that a phase I study of the drug could begin as soon as early 2013, Benitec said. However, due to Pfizer's closing of the UK site handling the drug, its development schedule is “unclear.”
Benitec added that Tacere's management is pursuing other partnering opportunities for TT-034.
Officials from Tacere did not return a request for comment.