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Achillion Announces Updated Phase 2 Results Including Early Sustained Virologic Response On ACH-3102 Plus Ribavirin In Genotype 1b Treatment-Naive Hepatitis C Patients

Stocks in this article: ACHN

- ACH-3102 deemed safe and well-tolerated following 12 weeks of therapy - - High barrier to resistance demonstrated with no on-treatment virologic breakthrough observed - - Novel NS5A inhibitor study supports differentiated profile of ACH-3102 -

NEW HAVEN, Conn., April 23, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced updated interim safety and efficacy results, including early sustained virologic response (SVR4) data, from the pilot Phase 2 trial evaluating once-daily ACH-3102 plus ribavirin (RBV) in treatment-naïve patients with genotype 1b, IL28B CC subtype, chronic hepatitis C virus (HCV) infection. All of the 8 patients enrolled in the trial completed 12 weeks of treatment with no virologic breakthrough observed. ACH-3102 also demonstrated continued declines in HCV RNA in the presence of up to six baseline mutations that are known to confer a high level of resistance to 1 st generations NS5A inhibitors. ACH-3102 was deemed safe and well-tolerated with no significant adverse events reported. In all, 75% of patients (6 of 8) had HCV RNA < 25 IU/ml at the end of treatment and 63% (5 of 8) achieved early sustained virologic response 4 weeks (SVR4) after the completion of therapy.

Dr. Andrew Muir, Principal Investigator and Assistant Professor of Medicine and Director of Gastroenterology/Hepatology Research at Duke Clinical Research Institute commented, "The preliminary results from this novel study of a single DAA, an NS5A inhibitor, plus ribavirin demonstrates the safety, high barrier to resistance, and preliminary efficacy of ACH-3102. The profound activity of ACH-3102 as a single DAA, along with its safety profile and lack of virologic breakthrough to date makes this a very promising compound to study further in combination with other oral agents, including sovaprevir, for the treatment of HCV."

Overall, ACH-3102 was well-tolerated and demonstrated a safety profile consistent with that seen during Phase 1 trials in both healthy subjects and HCV-infected patients. No patients experienced virologic breakthrough while on treatment and no patients discontinued treatment due to an adverse event. Final study results are expected to be submitted for presentation at a medical conference later this year.

  Virologic End Points
Total 8 subjects enrolled RVR ETR SVR4
  n = 8 n = 8 n = 8
# of subjects 6 / 8 6 / 8* 5 / 8 **
(%) (75%)  (75%) (63%)
RVR = Rapid Virologic Response, HCV RNA < LLOQ (< 25 IU/mL) at week 4 of treatment
ETR = End of Treatment Response, HCV RNA < LLOQ (< 25 IU/mL) at week 12 of treatment
 * The 2 patients who did not achieve ETR were started on pegylated interferon, ribavirin and telaprevir at the end of the 12-week treatment period, and demonstrated undetectable viral levels beginning at week 13.
** 1 patient with virologic relapse at week 15.

"We believe that these interim results further strengthen our position that ACH-3102 is a differentiated NS5A inhibitor possessing attributes that make it a true second-generation compound," commented Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "The safety and efficacy profile support our recently initiated Phase 2 -007 trial evaluating 12 weeks of our protease inhibitor, sovaprevir, in combination with ACH-3012 for the treatment of genotype 1 HCV. With that study now underway, we look forward to reporting interim results beginning in the third quarter of this year, and will continue to explore and execute opportunities to combine our agents with other compounds that could further shorten the treatment duration or provide additional flexibility for treatment regimens to broadly cure HCV."

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