Ron Renaud, CEO of Idenix Pharmaceuticals (NASDAQ:IDIX) announced late Tuesday:
We are encouraged by the initial SVR results from the phase IIb program, which have confirmed previous data showing that IDX184 is a potent nucleotide "nuc" inhibitor with a profile supporting its potential role as a key component of all-oral direct-acting antiviral (DAA) combination regimens for HCV.
Idenix announced positive clinical data for HCV drug candidates IDX184 and IDX719 in their pipeline. Of the first cohort of 31 patients enrolled in the study, those who achieved an eRVR (n=18), defined as having undetectable levels of virus at 4 weeks and 12 weeks, were randomized to stop treatment after either an additional 12 weeks (n=9) or 36 weeks (n=9) of PegIFN/RBV. Of the nine patients who completed their 12-week PegIFN/RBV extended treatment phase, 100% of patients (4/4) in the 100 mg arm and 80% of patients (4/5) in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment (SVR4). Patients who did not achieve an eRVR automatically entered the 36-week PegIFN/RBV extended treatment phase which is ongoing. To date, the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.
If you have followed us on this company in the past few months, we previously disclosed that there are some events currently underway in the Hepatitis C arena compiled with facts from industry experts and articles over the last several weeks about what is currently talking place right now.
Hepatitis C virus (HCV) reports say that there about 170+ million people globally, including 4.1 million Americans, and annual projections range from $3 billion to $20 billion by 2020. Volume may be seen as high as $100 billion over the next decade according to Mark Schoenebaum of ISI Group. Mark Schoenebaum is a Senior Managing Director, heads ISI's Health Care Research Team and is ISI's Biotechnology & Pharmaceuticals-Major Analyst. He has been ranked Institutional Investor #1 biotechnology analyst for the past 7 years. In addition, Mark has been highly ranked in the Greenwich Associates survey for several years.
HCV spreads through contact with contaminated blood which is the most common form of the virus who carry the virus. It's by far the leading cause of chronic liver disease, and can lead to liver cancer. The current treatment includes treatment which is not tolerated by everyone and includes injections of the drug interferon alpha, which side effects include fatigue, fever and depression. Most liver transplants performed in the U.S. are due to progressive liver disease caused by the Hepatitis C virus.
We are on the threshold of a watershed moment in the treatment of Hepatitis C - according to a recent editorial in the New England Journal of Medicine. A world-renowned expert in the field, Raymond Chung, MD, from Massachusetts General Hospital and Harvard Medical School opines, "This is a watershed moment in the annals of HCV therapy because it shows that a sustained virologic response can be achieved without interferon.
Implicit in this finding is the concept that 2 potent agents with complementary resistance profiles, given for a sufficient duration, can impose a stranglehold on viral replication and result in clearance of the virus." More significantly he suggests:
Can we do even better? Certainly, with inclusion of "nucs"...nucleotide polymerase inhibitors, which are unique among direct-acting antiviral classes because they offer a high barrier to the selection of viral resistance we can anticipate regimens with substantially lower breakthrough rates. He concludes; "We are on the threshold of a treatment revolution that will greatly improve the effectiveness of HCV therapy by dramatically increasing the number of persons treated. There has never been a more exciting time for patients and providers who grapple with this silent killer.
The stage has been set for effective a complete cure in a hitherto incurable and widespread disease by aggressive and judicious use of combination therapy with a regimen that includes distinct antiviral classes esp. nucleotide polymerase inhibitors, given their high genetic barrier to resistance and pan-genotypic coverage, will be a crucial ingredient in such combination regimens.
Analysts feel that IDX184 can be used as a "patch" and needs another potent drug to cover for its shortcomings. Combined drugs are desired because they attack different checkpoints for the HCV disease as they travel through the body. This last nuc could be the right patch?
Industry experts and our research suggests that it is very possible that Merck's (NYSE:MRK) FDA already approved drug MK-5172 / Victrelis (boceprevir) is the Best fit for IDX184.
As suggested, the most notable drug in Merck's HCV pipeline is its FDA approved first-in-class, oral hepatitis C virus (HCV) NS3/4A protease inhibitor,MK-5172, a pan-genotypic protease inhibitor (Pending:PI). However MK-5172, despite high potency, has one potential drawback in that it may still select for fit mutations due to lower genetic barrier to resistance as compared to the nukes. It would hence make sense for this to be paired with a nucleotide polymerase inhibitors, given their high genetic barrier to resistance.
A once daily PI + nuc combination of MK-5172+IDX184 might well be one of the attractive treatment options for Hep C infection. The fact is Merck desperately needs to find a nuc for MK-5172 to remain relevant in the field of Hep C, and IDX184 is now the only nuc left in the field that is in Phase II development.
In conclusion, we are in the midst of a Hep C "Gold Rush," so to speak, and as industry experts feel, just as we do... it's really just a matter of time before we find out more about the right suitor for Idenix's nuc drug candidate IDX184. Remember, reports suggested that Inhibitex (NASDAQ:INHX) was acquired for $2.5B for their 1 drug candidate and there were as many as 5 bidders, four who lost out, but may be eying Idenix? Further, Inhibitex only had 1 drug, but Idenix has at least "four" with a very strong pipeline.
Here is a link to the Idenix pipeline according to their website. Good luck and we will stay tuned for more positive updates to follow from Idenix in the coming weeks. Here is another article discussing more about IDIX written on June 12, 2012.
Disclosure: I am long IDIX.