The European Association of the Study of Liver Disease wrapped up on Sunday in Copenhagen. Here are some of the hightlights of all things hepatitis C:
However, the viral load reductions and number of patients with undetectable levels of virus achieved by various dose combinations of ITMN-191 and R7128 over 14 days fell short of past studies combining a more potent oral drug like Vertex Pharmaceuticals' ( VRTX) telaprevir with standard of care for hepatitis C (long-acting injectable interferon and ribavirin). The INFORM-1 study is a solid proof of concept that an all-oral combination therapy for hepatitis C is possible, but Roche, InterMune and Pharmasset are going to have to show that higher doses of the drugs, especially of InterMune's ITMN-191, produce stronger antiviral efficacy in order to make it possible to eliminate the use of interferon and ribavirin.
INFORM-1 DataRoche, InterMune ( ITMN) and Pharmasset ( VRUS) provided the most eagerly anticipated clinical data of the conference Saturday with results from a 14-day trial combining two experimental direct antivirals -- InterMune's ITMN-191 with Pharmasset's R7128 -- given to patients with treatment-naïve hepatitis C. Roche is a development partner on both drugs. The companies called the INFORM-1 study "ground breaking" and rightly so in that this trial was the first time that two oral drugs -- both of which stop the hepatitis C virus from replicating itself, albeit in different ways -- were shown to be safe and effective in lowering viral loads in patients when taken in combination.
Vertex's TelaprevirVertex had a fairly quiet EASL conference, mainly because telaprevir is in the middle of phase III studies that won't have data available until next year. Still, the company did present previously disclosed data showing that telaprevir is capable of significantly improving cure rates in the most difficult-to-treat patients who had failed prior treatment with the current standard drug regimen for hepatitis C -- a 48-week course of long-acting interferon plus ribavirin.
This data keeps telaprevir ahead of its hepatitis C rivals because no other drug has yet shown the ability to improve the cure rates for both patients new to therapy as well as those who have failed prior therapy. Telaprevir was the "butt" of some negative EASL chatter due to an anecdotal report that the drug was causing severe anal itching in patient(s). One EASL attendee described the side effect as "fire in the hole." All jokes aside, itchy rash is a well-known and documented side effect of telaprevir, but there have been no confirmed reports of anal pruritis (the medical term for anal itching) in any of the telaprevir studies presented to date. In fact, patient discontinuation rates due to telaprevir-induced rash appear to be on the decline, as doctors and patients learn how to better manage the side effect. This should lead to higher cure rates for telaprevir in the ongoing phase III studies compared to the already high rates seen in the phase II trials.
Anadys' ANA598 and RashAnadys Pharmaceuticals' ( ANDS) share price has not yet recovered from the emergence last week of a rash associated with its experimental drug ANA598. The company contends that investors are more worried about rash than doctors using the drug in clinical trials and the emergence of this potential side effect will not derail the drug's development. However, Anadys only has another quarter or two of cash left and doesn't have enough money on hand to begin the next round of ANA598 clinical trials. Anadys is negotiating with potential partners for ANA598 but if talks are delayed, the company could be forced to raise money though another dilutive financing.
Schering-Plough's ( SGP) boceprevir made some headlines last week with phase II cure rates numerically higher than what's been reported by Vertex's telaprevir in its phase II studies. But boceprevir still doesn't look competitive because the drug is causing significant rates of anemia in patients and requires dosing up to 48 weeks compared to 24-week dosing for telaprevir. Boceprevir is also ineffective for patients who have failed prior treatment.