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100% SVR reported in Phase 2a trial evaluating odalasvir, AL-335, and simeprevir for genotype 1 treatment-naive HCV

September 11, 2016

Achillion announces 100% SVR reported in Janssen’s Phase 2a trial evaluating triple combination of odalasvir, AL-335, and simeprevir for genotype 1 treatment-naive HCV

Janssen advancing triple combination into Phase 2b clinical trial

NEW HAVEN, Conn., Sept. 09, 2016 — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that new interim results from a phase 2a study being conducted by Alios BioPharma, Inc., part of the Janssen Pharmaceutical Companies (Janssen), were published as part of the abstracts released for the upcoming European Association for the Study of the Liver (EASL) Special Conference, September 23 – 24, 2016, in Paris, France.

This ongoing phase 2a study was designed to confirm the required dose and treatment duration for an all-oral combination regimen containing odalasvir (ODV) and AL-335 with or without simeprevir (SMV) for durations of eight or six weeks of treatment in treatment-naïve patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

“We are delighted by the significant progress Janssen has made in advancing the all-oral, short-duration treatment regimen of odalasvir, AL-335 and simeprevir and are impressed with the Phase 2a study results being presented. Based on these interim results, Janssen plans to advance a phase 2b program for the triple combination to further understand the potential of this 3DAA drug combination to shorten the duration of treatment for patients suffering from HCV,” commented Dr. Milind Deshpande, President and Chief Executive Officer of Achillion. “Despite recent therapeutic advances, we believe there remains a significant unmet need in addressing the global burden of hepatitis C virus in those living with the disease.”

Data included in the abstract were as of the time of submission in July 2016. Updated results, including sustained viral response 12 weeks after completion of therapy (SVR12) for all cohorts, are scheduled to be presented on Friday, September 23, 2016, in an ePoster entitled “Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection.” Interim results from cohorts 1-4, summarized in the table below, showed that the triple combination regimen was highly effective and well tolerated in non-cirrhotic patients with GT1 HCV.

Table 1: Interim Phase 2a Results for Cohorts 1 — 4

Dose Dosing
Number (%) with
undetectable* HCV RNA
(EOT or SVR)
(mg QD)
(mg QD)
1 400 50 QD 100 8 20/20 (100%), SVR24
2 800 50 QOD 8 18/20 (90%), SVR12
3 800 50 QOD 75 8 20/20 (100%), SVR4
4 800 50 QOD 75 6 20/20 (100%), EOT

*Or below the limit of quantitation (N=2; Cohort 4 only)
EOT: end of treatment; QD: every day; QOD: every other day; RNA: ribonucleic acid

Summary of Phase 2a Study Design and Interim Results

This phase 2a study was designed to determine the pharmacokinetics, efficacy and safety of ODV and AL-335 with or without SMV, in treatment naïve patients with GT1 or 3 HCV infection for treatment durations of eight weeks or less.

Of the 20 patients treated in cohort 1, who received the triple combination of odalasvir (50mg QD), AL-335 (400mg QD) and simeprevir (100mg QD) for eight weeks (triplet, 8 weeks), 100 percent remained HCV RNA undetectable 24 weeks after completing therapy (SVR24). Additional patients were subsequently enrolled into two further cohorts (3 & 4), where they received adjusted doses of the same triplet combination for either eight or six weeks. In cohort 3 all were HCV RNA negative and remained HCV RNA undetectable 4 weeks after completing therapy (SVR4) and in cohort 4 all were HCV RNA negative (N=18) or below the limit of quantitation (N=2) at end of treatment. Of the 20 patients treated in cohort 2, who received the dual combination of odalasvir (50mg QOD) and AL-335 (800mg QD) for eight weeks (doublet, 8 weeks), 90 percent remained HCV RNA undetectable twelve weeks after completing therapy (SVR12).

All-oral combination regimens, containing odalasvir, AL-335 with or without simeprevir were generally safe and well tolerated. The majority of adverse events (AEs) were mild, most commonly headache, fatigue, and upper respiratory tract infection. In cohort 1, there was a single serious adverse event (Mobitz Type 1 2nd degree atrioventricular block), which was attributed to treatment. This ECG abnormality was not associated with clinical or echocardiographic abnormalities, and resolved following treatment discontinuation. No clinically significant laboratory abnormalities were observed.

Ongoing Phase 2 Development Program

Based upon the interim results from the phase 2a study, which confirmed the required dose for each component and the treatment duration, the triple combination is being advanced into a phase 2b program consisting of once daily odalasvir 25mg, AL-335 800mg, and simeprevir 75mg. The development program will include two multi-center, randomized, open-label studies that will enroll treatment-naive and treatment-experienced non-cirrhotic patients chronically infected with hepatitis C virus genotypes 1, 2, 4, 5, and 6. These studies will be complemented by an expansion of the ongoing phase 2a study focusing on patients with or without compensated cirrhosis and on patients with HCV genotype 2 and 3 infection. The results from the phase 2 program will guide further development.

Further information on this study can be found at www.clinicaltrials.gov. Study identifier: CT02765490.

About HCV

Globally, HCV infection is a leading cause of liver disease and liver related mortality. It is currently estimated that more than 150 million people are infected with HCV worldwide including approximately 3 million people in the United States. Three-quarters of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Despite available treatments, there remains a significant unmet need for many patients infected with HCV.

About Achillion Pharmaceuticals

Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) is a science-driven, patient-focused company seeking to leverage its strengths across the continuum from discovery to commercialization in its goal of providing better treatments for people with serious diseases. The company employs a highly-disciplined discovery and development approach that has allowed it to pursue best-in-class oral antiviral therapy for chronic hepatitis C (HCV) and build a platform of potent and specific complement inhibitors. Achillion is rapidly advancing its efforts to become a fully-integrated pharmaceutical company with a goal of bringing life-saving medicines to patients with rare diseases. More information is available at http://www.achillion.com.

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