I know the Pharmasset folks are bullish about a interferon-free drug combo to treat HCV - actually, we ALL are, but until we have SVR data from that particular combination and others like it in development, interferon is here to stay. Biolex (who features ex-Vertex CCO Kurt Graves as it's Executive Chairman of the Board) is the entity here in the States that is developing Locteron. The deal with Locteron is that it's a Peg-less PegIntron with a sexy new controlled release technology that allows it to be dosed every other week. Added benefits are a nice reduction in flu-like side-effects and interferon-related depression. Results of it's Phase IIb study, SELECT-2, comparing it to Pegintron look pretty good. Locteron maintains and/or beats it's pegylated cousin in the SVR department (SVR 41% (640 μg); 34% (480 μg); 36% (320 μg); 33% (Pegintron))while chopping the number of shots in half and reducing AE's. The big problem at this point isn't the threat of an interferon-free HCV drug combo, but lack of data with a DAA. I'm not schooled in Biolex, but I'm sure that's the company's hope going forward. Or it may just file with a DAA-less indication if the Phase III data and competitive environment look promising enough. Either way, the thought of a more user-friendly interferon is pretty enticing. Hopefully, investors will feel the same way.
OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces that its licensee Biolex Therapeutics will present today final results from the Locteron® Phase IIb clinical study at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. These data highlight important tolerability advantages of Locteron versus current HCV treatments.
Jan Egberts, CEO of OctoPlus, comments: "These positive final results from the Phase IIb clinical study with Locteron further confirm the long term benefits of Locteron's controlled release mechanism. Our PolyActive technology has enabled the development of an interferon alpha with a significantly improved side effect profile, achieving both a 50% reduction in flu-like adverse events and substantially lower rates of depression compared to conventional interferon treatments. In combination with its reduced injection frequency, these benefits clearly position Locteron as the interferon of choice for future hepatitis C treatments."
The following information was taken directly from Biolex' press release (see www.biolex.com).
Biolex announces that final 72-week results from its SELECT-2 Phase 2b trial of Locteron® for the treatment of hepatitis C are being presented today at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in Berlin, Germany. Data presented today show that Locteron achieved the SELECT-2 study objectives by demonstrating viral kinetics and response rates that were comparable with or exceeded the PEG-Intron® control while also achieving a statistically significant reduction in flu-like adverse events, reduced rates of depression, lower use of concomitant medications and a reduced rate of discontinuation due to adverse events. Locteron, the only controlled-release interferon alpha, is designed to offer key tolerability and dosing advantages over currently marketed interferons and serve as a core component of new combination therapies as the treatment of hepatitis C evolves to triple- and quad-drug regimens.
Locteron dosing convenience and efficacy
Locteron is administered once every other week and requires half as many injections as the currently marketed interferons, each of which are injected once per week. In SELECT-2, the sustained virologic response rate (SVR) for each of the three Locteron doses studied was comparable with or exceeded the response rate for the PEG-Intron control as outlined in the table below.
Click on the link for the press release including tables.
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