2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir
for Genotype 1 HCV (“Proxy Study”) Including Nine of 12 Patients With
Viral Loads Higher Than 6 Million IU/ml at Baseline –
NEW HAVEN, Conn., Nov. 8, 2014 (GLOBE NEWSWIRE) — Achillion Pharmaceuticals, Inc.
(Nasdaq:ACHN) today announced the presentation of results from the
ongoing Phase 2 study of ACH-3102 in a late breaker poster and data in
three preclinical posters on ACH-3422. The poster presentations are
being made at the 65th Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD), The Liver Meeting
2014, which takes place through November 11, 2014 in Boston, MA.
Breaker Poster Presentation: Phase 2 pilot study evaluating eight week
treatment of ACH-3102 in combination with sofosbuvir for genotype 1
In a late breaker poster presentation, Achillion reported updated
interim results from an ongoing interferon-free, ribavirin-free, Phase 2
open-label, randomized, partial-crossover study to evaluate the
efficacy, safety, and tolerability of eight weeks or six weeks of
ACH-3102 and sofosbuvir, a marketed nucleotide polymerase inhibitor,
without ribavirin, in treatment-naïve genotype 1 HCV-infected patients.
The primary objective of the study is determination of sustained viral
response 12 weeks (SVR12) after the completion of therapy. Eighteen
patients were enrolled, including six observational patients. Twelve
patients completed eight weeks of treatment consisting of 50 mg of
ACH-3102 and 400 mg of sofosbuvir administered once daily while
observational patients received no drug during this phase of the trial.
Of the 12 patients treated, 100 percent (n=12/12) achieved SVR12. Of
the 12 patients treated in this study, nine of 12 patients had a
baseline viral load substantially greater than 6 million IU/ml at
baseline. No on-treatment viral breakthrough or post-treatment viral
relapse has been observed.
Preclinical poster presentations on ACH-3422
Achillion presented three posters at AASLD which reported updated
preclinical results on ACH-3422. The in vitro results demonstrated that
this nucleotide pro-drug has improved potency against genotype 3 HCV as
compared to sofosbuvir. In addition, in a separate poster presentation,
Achillion reported that ACH-3422 displays additive to synergistic
activity when combined with ACH-3102 or sovaprevir, Achillion’s Phase 2
NS3/4A protease inhibitor, in vitro. Furthermore, the high barrier to
resistance for ACH-3422 was supported with the ability of the agent to
block, in vitro, the appearance of resistant colonies in combination
with other direct-acting antiviral agents.
“The antiviral activity and safety profile observed to date for
ACH-3422 both in preclinical studies and in the ongoing 422-001 Phase 1
trial support further development with this nucleotide in combination
with Achillion’s other direct-acting antivirals, and represents an
exciting treatment option for 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 ACH-3422 Phase 1 proof-of-concept study and Phase 2 proxy study of
ACH-3102 and sofosbuvir.
Reprints of the posters are available on the Company’s website at www.achillion.com/resources.
About Achillion Pharmaceuticals
Achillion is seeking to apply its expertise in biology and
structure-guided design and a deep understanding of patient and
clinician needs to develop innovative treatment solutions aimed at
improving patients’ lives. The company’s scientific excellence,
integrated capabilities and experienced team position it to successfully
achieve its goal of advancing new products along the entire continuum
from the bench to the patient. Achillion’s pipeline is currently focused
on small molecule therapeutics for infectious disease and
complement-related diseases. www.achillion.com