Hep C Drug Stocks in the Spotlight By Adam Feuerstein 03/28/11 - 07:42 AM EDT
BERLIN, Germany (TheStreet) --Biotech and drug investors with interest in emerging treatments for hepatitis C turn their attention this week to the European Association for the Study of the Liver (EASL) annual meeting, which kicks off Weds. March 30.
The following is a company-by-company sketch of the hepatitis C drug research to be presented at EASL 2011 that is of most interest to the Street:
Achillion(ACHN)
Expect to see 28-day rapid viral response (RVR) data from a phase IIb study of Achillion's protease inhibitor ACH-1625. Three doses (200 mg, 400 mg and 800 mg, all once daily) are being given in combination with long-acting interferon and ribavirin, the current Hep C standard of care. The study also enrolls a control arm of patients receiving standard of care alone. All the Hep C patients enrolled in the study of ACH-1625 are previously untreated.
Achillion is not presenting the ACH-1625 data at EASL but will be releasing the study results in advance of its own investor meeting at the conference, which is being held on Weds. March 30.
In terms of expectations, ACH-1625 should yield RVR rates of at least 80% in order to meet the potency of competing Hep C drugs. An RVR result in the 90%-plus range would be superior, according to JMP Securities analyst Liisa Bayko.
ACH-1625's safety profile is equally important. In particular, investors will be looking for any sign that the drug raises liver enzymes or in any way signals liver toxicity.
Bristol-Myers Squibb(BMY)
A phase IIb study of its experimental once-daily drug BMS-790052 plus standard of care yielded undetectable rates of 92% and 83% for the 10 mg and 60 mg dose arms, respectively, compared to 25% for patients treated with standard of care alone, according to the EASL abstract. Response rates were determined 12 weeks after the end of treatment and the study enrolled previously untreated patients.
Bristol is also studying a "quad" regimen consisting of BMS-790052, BMS-650032 plus standard of care in patients who failed to respond to previous therapy.
Gilead Sciences(GILD)
An early study of GS-9190 plus standard of care resulted in an unimpressive 56% response rate but more promising results may come from a "quad" regimen consisting of two experimental Gilead drugs, GS-9190 and GS-9256, plus standard of care. Twelve weeks of treatment with the Gilead quad regimen resulted in all 14 patients enrolled achieving undetectable levels of virus, according to the EASL research abstract.
Investors may also get the first look at efficacy and safety data from another early-stage Gilead drug, GS-5885.
Inhibitex (INHX)
Outside of the EASL conference, Inhibitex may announce updated results from an early study of INX-189 both alone and in combination with ribavirin.
Johnson & Johnson(JNJ) and Medivir
A trio of phase III studies of TMC435 are underway but interim data from a phase IIb study of treatment-experienced patients will be shown at EASL. After 24 weeks of treatment, 85% to 90% of patients treated with TMC435 plus standard of care reported undetectable levels of virus compared to 52% of patients treated with standard of care alone, according to the EASL research abstract.
Updated data from this study will be presented at the conference. TMC435 is dosed once daily which gives it a potential advantage over the three-times-daily dosing of Vertex Pharmaceuticals'(VRTX) telaprevir and Merck's(MRK) boceprevir.
Pharmasset(VRUS)
A mid-stage study of two oral Pharmasset drugs -- PSI-938 and PSI-7977 -- has already garnered enormous buzz even before EASL starts later this week. Treatment with the two oral drugs resulted in 15 of 16, or 94%, of patients reporting undetectable levels of the hepatitis C virus after 14 days, according to a research abstract describing the phase II study released earlier this month.
These early results are the best reported to date by any company seeking to develop a new, all-oral therapy for hepatitis C. This Pharmasset effort is drawing even more attention because it potentially eliminates the need for patients to be treated with long-acting interferon and ribavirin, the current standard of care for hepatitis C.
Further details from the combination study of PSI-938 and PSI-7977, including data on the safety of the two drugs, will be presented on Thursday, March 31.
Pharmasset will also be presenting data from a separate study of PSI-7977 in combination with standard of care. After four weeks of treatment, 98% of patients treated with PSI-9877 plus standard care had undetectable levels of the Hep C virus, according to the research abstract released earlier this month. Results following 12 weeks of treatment will be presented at the meeting.
Vertex Pharmaceuticals(VRTX)
The most highly anticipated data from Vertex comes from a phase II study of a "quad" regimen consisting of two experimental oral drugs, telaprevir and VX-222, plus standard of care.
After four weeks of treatment with the quad regimen, 86% and 87% of patients had undetectable levels of the hepatitis C virus. None of the patients experienced viral rebound, according to the research abstract released earlier this month. Results following longer treatment will be presented at the meeting.
Vertex tried to treat two groups of patients with a combination of telaprevir and VX-222 without standard of care but this arm of the study was discontinued because 17% and 31% of patients, respectively experienced viral breakthrough, according to the abstract.
Vertex will present additional data from its phase III studies of telaprevir, although these studies will have less of an impact since telaprevir is already under review by regulators in the U.S. and Europe. The next major catalyst for Vertex and telaprevir comes April 27-28 when an FDA advisory panel convenes to review both Merck's competing Hep C drug boceprevir and telaprevir. --Written by Adam Feuerstein in Boston.
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