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Achillion Presents New Data On ACH-3102 To Treat Hepatitis C At The International Liver Congress

- Phase 1 Results Further Demonstrate Potency of ACH-3102 in Genotypes 1a and 1b and Against Resistant HCV-

- Study Shows ACH-3102 and Sovaprevir Can be Co-Administered Without Interaction -

- Total of Six Poster Presentations to be Made During EASL -

AMSTERDAM, The Netherlands, April 23, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced the presentation of new data demonstrating the efficacy, safety, tolerability, and combinability of ACH-3102, a second-generation, pan-genotypic NS5A inhibitor, at the 48 th Annual Meeting of the European Association for the Study of the Liver (EASL) during the International Liver Congress 2013. ACH-3102 and sovaprevir are currently in Phase II combination development for the treatment of patients with chronic Hepatitis C infection (HCV). During the upcoming poster presentations, data will be reported that demonstrates ACH-3102 achieves a reduction in HCV RNA despite the presence of resistant variants. In addition, ACH-3102 demonstrates no drug-drug interaction with sovaprevir, Achillion's second-generation protease inhibitor.

Data highlights include:

Poster No. 876: A Second Generation NS5A Inhibitor, Demonstrates Potent Antiviral Activity in Patients with Genotype 1A HCV Infection Despite the Presence of Baseline NS5A-Resistant Variants. Friday, April 26, 2013: Poster Session – Category 08c: Viral Hepatitis C: Clinical (therapy).

  • Treatment naïve patients with genotype 1 chronic HCV infection, patients received a single dose of ACH-3102 at various doses (Group 1: 50 mg, n=4; 150 mg, n=4; 300 mg, n=4 or placebo, n=2) or placebo and were evaluated for baseline NS5A-resistant viral variants, which was present in the majority of patients. Based on the robust anti-viral effect observed in Group 1, a lower dose (25 mg, n=6) of ACH-3102 or placebo (n=3) was studied in Group 2.
  • All tested doses of ACH-3102 were safe and well-tolerated in subjects with chronic HCV Genotype 1 infection.
  • Robust, rapid and sustained suppression of plasma HCV RNA levels was observed in all doses (mean reduction of 4.04 log 10, 3.78 log 10, 3.52 log 10, and 3.93 log 10 IU/mL for 25 mg, 50 mg, 150 mg and 300 mg doses, respectively, versus reduction of 0.68 log 10 IU/mL for placebo). Plasma HCV RNA levels sharply declined within the first two days post-treatment, and remained lower than baseline for at least 14 days.
  • ACH-3102 retains potent anti-viral activity against both wild-type and NS5A-resistant viral variants, differentiating it from first-generation NS5A inhibitors.

Poster No. 1201: No Clinically Significant Pharmacokinetic Interaction between Sovaprevir and ACH-3102 in Healthy Volunteers. Saturday, April 27, 2013. Poster Session – Category 08d: Viral Hepatitis C: Clinical (new compounds, resistance).

  • In a 24-patient healthy volunteer study, there was no clinically significant pharmacokinetic interaction between ACH-3102 and sovaprevir, Achillion's 2 nd generation NS3 Protease Inhibitor (PI), when co-administered with or without food.
  • Co-administration of ACH-3102 and sovaprevir was deemed safe and well-tolerated and the results support a combination Phase 2 study which is currently underway

Poster No. 1199: Findings from Clinical Virology Studies on ACH-3102 are Consistent with Preclinical Observations on its Improved Potency Against Genotype-1A HCV and Resistant Variants. Saturday, April 27, 2013: Poster Session – Category 08d: Viral Hepatitis C: Clinical (new compounds, resistance).

  • Single doses of ACH-3102 at 25 mg - 300 mg have previously shown robust antiviral activity in Genotype 1a patients, with reductions in HCV RNA observed in presence of baseline mutations associated with viral resistance to NS5A inhibitors.
  • These results show that ACH-3102 administered in 50 mg, 150 mg, and 300 mg doses reduced viral load by 3.98-4.60 log 10 IU/mL in four patients with Y93C/D/H mutation, 3.35-4.02 log 10 IU/mL in four patients with M28T/V mutation, and 3.40 log 10 IU/mL in one patient with L31M mutation.
  • Also in GT-1a patients, a comparison of 1-150 NS5A versus full-length NS5A showed less than five-fold differences in their susceptibility to ACH-3102, compared with up to a greater than 358-fold differences in susceptibility to daclatasvir.
  • ACH-3102 retained potency (EC 500.042 nM) in GT-1b patients with pooled NS5A mutations, all of whom carried the L31M and Y93H double mutation. In contrast, daclatasvir potency was reduced 2,200-fold (EC 50 22 nM).

"The high barrier to resistance observed with ACH-3102 to date continues to confirm our view that ACH-3102 is unique from other NS5As and has the promise to be a cornerstone therapy in the treatment of Hepatitis C," said Milind Deshpande, Ph.D., President of Research and Development and Chief Scientific Officer of Achillion. "The unique characteristics of ACH-3102, combined with the unique profile of our 2nd generation PI, sovaprevir, which also has a higher barrier to resistance than typical PIs, make for what we believe is a high potential combo, competitive against both current and emerging combinations."

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