Wednesday, October 17, 2012

A New And Interesting Addition To The Hep C Clinical Pipeline

Investment Commentary

A New And Interesting Addition To The Hep C Clinical Pipeline

Leonard O'Brien / Seeking Alpha
The race towards an interferon-free hepatitis C treatment continues to heat up, with a newcomer to the clinical pipeline - BioLine Rx's (BLRX) BL-8020. The Israeli company, which in-licensed the drug earlier this year, announced that it had successfully completed the pre-clinical development of the anti Hep C drug, and that a phase I/II is planned to begin in Europe during the first quarter of 2013.

Unlike the vast majority of Hep C drugs under development, BL-8020 is not a protease or polymerase inhibitor. In fact, this drug doesn't directly target the hepatitis virus at all, but instead, targets the host cell. BL-8020 inhibits a naturally occurring mechanism in the cell termed "autophagy", which is used by the hepatitis C (and other viruses) for its replication process. This unique mechanism of action provides BioLine's drug with several advantages:

1. BL-8020 can potentially be combined with any other anti-Hep C drug as part of an all oral, interferon-free cocktail.
2. Targeting the host cell rather than the virus itself is very likely to result in an effective treatment of all the Hep C genotypes. Until today, most drug candidates are mostly effective in genotype-1 patients.
3. The different MOA could be beneficial when approaching patients who failed to respond to SOC treatment.

Looking at protocols used in previous early-stage clinical studies with Hep C drug candidates, we can assume that several dozens of patients will be enrolled in the upcoming trial, and results can be expected within about a year. It will be interesting to see which drug cocktail (if any) will be tested by BioLine in this study, and whether the company will challenge itself with non-responders, or will enroll treatment naïve patients only. In my opinion, the latter subject is of critical importance - some experimental Hep C agents proved effective in treatment naïve patients, but failed to produce similar success when tested on patients who have not responded to previous treatment.

The nature of clinical trials with Hep C treatments promises a trickle of information throughout the duration of the study, with endpoints at several time points of the treatment, mainly at weeks 4 and 12. Such expected interim data may cause surges in BioLine's stock price and interested investors should closely monitor this already volatile stock.

Analysis of the Hep C pipeline reveals that there are currently 14 agents in phase I, 19 agents in phase II, and 4 in phase III. However, the vast majority of these drug candidates is directed against only 4 targets, and is being developed by a handful of companies, including Abbott (ABT), Gilead (GILD), Achillion (ACHN), Boehringer Ingelheim, Bristol-Myers Squibb (BMY), Vertex (VRTX), Idenix (IDIX) and Merck (MRK). This results in a very competitive field on one hand, and high levels of "cross-reactions" on the other, as seen in the case of BMS and Idenix last August.

Besides BL-8020, noteworthy anti-Hep C agents that do not target the NS3/4/5 viral proteins are iTherX's ITX-5061 (virus entry inhibitor), and Biotron's (ASX:BIT) BIT225 (viral assembly inhibitor). These two agents, currently in Phase I and II respectively, deserve a close look by investors following the advancements in the Hep C field.

Should BL-8020 prove to be a safe and effective drug as a part of an all oral anti-Hep C cocktail, it is bound to attract the attention of several players in the field, mainly due to its outside the box therapeutic approach to Hep C treatment.

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