UPDATED: Buoyed by 6-week hep C data, Achillion sets out to test even faster cure

While Regulus was getting dinged this morning following some careful scrutiny of its latest hep C data, Achillion came out on top with new trial results which demonstrated that a combination of its NS5A inhibitor and Gilead's Sovaldi triggered a 6-week cure among all of the patients in a small study. And now researchers are using the data to set the stage to see if the results can be replicated even faster in a 4-week trial.

Investigators found that 50 mg of ACH-3102 and 400 mg of sofosbuvir did the trick for 12 out of 12 treatment-naive genotype 1 patients. CEO Milind Deshpande touted the results as the shortest duration, highest response results yet seen. He added: "Given the exceptional profile of ACH-3102, we will now be evaluating four- and six-week treatment durations that leverage all of our HCV assets including ACH-3102, ACH-3422, and sovaprevir."

Achillion is still looking to enter a fast-crowding marketplace. Competing drugs from Gilead and AbbVie have forced out earlier standard remedies with oral combos that are much easier to tolerate and much more likely to provide a lasting cure. The goal now is to find ways to do it quicker and with less expense, providing an opening for some of the companies still in the hunt.


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Achillion Achieves 100% SVR12 in Phase 2 Trial Evaluating 6-Week Combination Treatment With ACH-3102

- Achillion achieves 100% SVR12 in six-week regimen with combination of ACH-3102 and sofosbuvir for treatment-naïve genotype 1 HCV -

- Achillion to initiate 4-week treatment regimens based on the strength of ACH-3102 antiviral data -

NEW HAVEN, Conn., Feb. 9, 2015 (GLOBE NEWSWIRE) --Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced updated interim results from the ongoing interferon-free, ribavirin-free, Phase 2 study to evaluate the efficacy, safety, and tolerability of six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, in treatment-naïve genotype 1 HCV-infected patients. The primary objective of the study is determination of sustained viral response 12 weeks (SVR12) after completion of therapy. One hundred percent of patients (12/12) in the six-week treatment duration arm achieved SVR12, which included patients with high baseline viral load.

"The ability to further shorten treatment duration to only six weeks and maintain excellent SVR12 rates remains the goal for clinicians and patients, and I am pleased that these Phase 2 results support that goal. The profile of ACH-3102, represents an important and exciting treatment option to shorten treatment duration for patients infected with HCV," commented Professor Edward Gane, M.D., Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and Lead Investigator in the Phase 2 study of ACH-3102 and sofosbuvir and the ACH-3422 nucleotide inhibitor program.

Dr. Milind Deshpande, President and Chief Executive Officer of Achillion, commented, "Our goal is to deliver short duration, widely accessible treatments to all HCV patients. We believe that these results with ACH-3102 represent the shortest duration and highest response achieved to date with any two-drug, direct-acting antiviral regimen for HCV. Given the exceptional profile of ACH-3102, we will now be evaluating four- and six-week treatment durations that leverage all of our HCV assets including ACH-3102, ACH-3422, and sovaprevir."

Overview of Phase 2 Proxy Study Design and Top-line Results
This ongoing study is a Phase 2 open-label, randomized, partial-crossover study to evaluate the efficacy, safety, and tolerability of eight- and six weeks of 50 mg of ACH-3102 and 400 mg of sofosbuvir, a marketed nucleotide polymerase inhibitor, once daily, in treatment-naïve genotype 1 HCV-infected patients. Initially, eighteen patients were enrolled, including six observational patients, into an eight-week treatment cohort.

Following the achievement of 100 percent SVR12 (12/12) in the eight-week cohort, the six-week treatment cohort was initiated. In all, eighteen patients were enrolled, including twelve active and six observational patients. Mean baseline HCV RNA viral load was 10 million (7 log₁₀) IU/ml, range 2 million (6.23 log₁₀) - 97 million (7.99 log₁₀) IU/ml, including seven patients with baseline HCV RNA viral load exceeding 6 million (6.78 log₁₀) IU/ml. Of the 12 active patients enrolled, seven patients were genotype 1a and five were genotype 1b.

Twelve weeks after the completion of therapy, 100 percent (12/12) achieved SVR12, independent of baseline viral load, gender, and IL28B status, in the six-week treatment arm. Additionally, one hundred percent of patients (12/12) in the eight-week treatment duration arm have achieved SVR24. The combination of ACH-3102 and sofosbuvir was well-tolerated with no serious adverse events, no discontinuations due to adverse events, and no clinically significant laboratory or ECG abnormalities.
"The achievement of 100% SVR12 after six weeks of treatment with a dual NS5A-nucleotide regimen, even in patients with high baseline viral load who would otherwise require extended duration treatments, supports our belief that ACH-3102 can unleash the potential of this combination to drive down treatment duration," commented Dr. David Apelian, Executive Vice President of Clinical Development and Chief Medical Officer at Achillion. "We are currently preparing to initiate our SPARTA Phase 2 program which evaluates short treatment durations with our proprietary once-daily regimens of ACH-3102 and ACH-3422, with or without sovaprevir, for treatment naïve genotype 1 HCV patients. In parallel, we plan on exploring sofosbuvir-sparing regimens that will leverage shorter durations of sofosbuvir in combination with ACH-3102 and sovaprevir as part of our global development program."

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Is the Promised Hepatitis C Drug War Finally Here?

Trial involving experimental medications shows six-week cure rate.

A small clinical trial has shown a combination of oral medicines can rid the body of the disease in as few as six weeks, which marks a big advancement in the treatment of hepatitis C.

The drugs included a combination of sofosbuvir and ledipasvir and one of two experimental drugs by Gilead Sciences, GS-9669 and GS-9451.

One obstacle to shorter treatments is cost. Harvoni (ledipasvir-sofosbuvir), the most recently approved rapid cure medication, costs around $95,000. The high price tag for this daily pill taken for 12 weeks poses challenges to public health insurers such as state Medicaid programs. Debates are raging surrounding who should have access to the medications and when.

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Six-week Oral Drug Trial Produces High Hepatitis C Cure Rates

A recent clinical trial, published in The Lancet, involving a 6-week course of a combination of 3 direct-acting oral drugs was found to cure 38 of 40 individuals with hepatitis C virus infection (HCV).

The researchers had found that a 6-week course of therapy is actually half the length of time typically reported to achieve a similar, successful cure rate using only2 direct-acting oral HCV drugs.

For the clinical trial, the first group of 20 volunteers were administered a 6-week course of the newly licensed drug sofosbuvir (Sovaldi) coupled with 2 additional direct-acting oral therapies, ledipasvir and GS-9669 – an experimental drug. The second volunteer group also comprised of 20 individuals had received another 6-week course of sofosbuvir, ledipasvir, and a different experimental drug, GS-9451

. - See more at: http://www.hcplive.com/articles/Six-week-Oral-Drug-Trial-Produces-High-Hepatitis-C-Cure-Rates#sthash.eftwAdC7.dpuf