November 16, 2015

AbbVie Announces High Sustained Virologic Response Rates in Phase 2 Studies with Pan-genotypic, Investigational Regimen in Patients with Chronic Hepatitis C

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- Investigational HCV regimen with ABT-493 and ABT-530 evaluating a pan-genotypic, once-daily treatment option with shorter duration of therapy
- Late-breaking data demonstrate 97 percent SVR(12) in genotype 1 non-cirrhotic chronic hepatitis C patients after 8 weeks of treatment with ABT-493 and ABT-530
- First patient enrolled in Phase 3 trials

NORTH CHICAGO, Ill., Nov. 16, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced data from the SURVEYOR studies of its investigational HCV regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, that show high rates of sustained virologic response at 12 weeks post-treatment (SVR12) in non-cirrhotic patients with chronic hepatitis C virus (HCV) infection. After 12 weeks of treatment, SVR12 rates achieved were 97-100 percent in genotype 1 (GT1), 96-100 percent in genotype 2 (GT2) and 83-94 percent in genotype 3 (GT3) patients.1,2,3 These data are being presented at The Liver Meeting® 2015, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco.

Separately, in a late-breaking presentation of the SURVEYOR-I study, data show non-cirrhotic GT1 chronic HCV patients who received a shorter duration of treatment for 8 weeks with ABT-493 and ABT-530 achieved a SVR12 rate of 97 percent.4

"These results are encouraging and contribute to scientific knowledge about the potential for pan-genotypic options for treating chronic hepatitis C," said Fred Poordad, M.D., vice president of Academic and Clinical Affairs at The Texas Liver Institute in San Antonio. "These data mark another important step in the continued research to help address the unmet needs of patients and the medical community."

SURVEYOR-I and SURVEYOR-II are ongoing Phase 2 clinical studies that evaluate the safety and efficacy of ABT-493 and ABT-530, with or without ribavirin (RBV), for 8 to 12 weeks. These data presented at AASLD include non-cirrhotic patients with GT1, GT2 and GT3 chronic HCV infection. Data in additional patient populations (genotypes 4-6) will be presented at future meetings.

"The SURVEYOR trials offer important new information about the potential to treat patients with chronic hepatitis C across multiple genotypes with our two direct-acting antiviral investigational regimen," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie's ongoing hepatitis C research program demonstrates our commitment to make a remarkable impact on the lives of HCV patients."

About SURVEYOR-I 
SURVEYOR-I is an ongoing Phase 2 two-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with and without ribavirin (RBV), for 8 to 12 weeks, in cirrhotic and non-cirrhotic adult genotype 1 (GT1) patients, and non-cirrhotic adult patients with genotypes 4, 5 or 6 chronic HCV infection who were new to therapy or did not respond to previous treatment with pegylated interferon (pegIFN)/RBV (null responder).1,4

In Part 1 of SURVEYOR-I, with 12 weeks of treatment, no patients discontinued treatment due to severe adverse events. The most commonly-reported direct-acting antiviral related adverse reactions (>10 percent of patients) were fatigue, headache and nausea. One patient experienced a serious adverse event of metastatic prostate cancer, unrelated to the study drugs and had onset after completion of study treatment.1 In Part 2, with 8 weeks of treatment, there were no study-related serious or severe adverse events reported. One subject discontinued the study at treatment week 4 due to adenocarcinoma, unrelated to study drugs. The most frequent adverse event (>10 percent of patients) was fatigue.4

About SURVEYOR-II 
SURVEYOR-II is an ongoing Phase 2 three-part study designed to evaluate the safety and efficacy of ABT-493 and ABT-530, with or without ribavirin (RBV), in cirrhotic and non-cirrhotic adult patients with genotype 2 (GT2) or genotype 3 (GT3) chronic HCV infection who were new to therapy or had failed previous treatment with pegIFN/RBV.2,3 In GT2 study patients, the most commonly-reported direct-acting antiviral (DAA)-related adverse reactions (>10 percent of patients) were fatigue, nausea, diarrhea and headache. No GT2 study patients discontinued treatment due to an adverse event; one patient experienced a serious adverse event of atrial fibrillation unrelated to the study drugs.2 In GT3 study patients, the most commonly-reported DAA-related adverse reactions (>10 percent of patients) were fatigue, nausea and headache. One patient discontinued treatment due to DAA- and RBV-related adverse events of abdominal pain and heat sensation. Two patients experienced a serious adverse event, one with pneumonia and one with B-cell lymphoma, both unrelated to the study drugs.3  Part 1 results of the SURVEYOR-II are presented at AASLD.

Overview of SURVEYOR-I and SURVEYOR-II Clinical Data Presented at AASLD:

SURVEYOR-I (Genotype 1, Non-cirrhotic)

Number of Patients (n)/

Patient Population

Duration of Treatment

 Treatment Arm

Treatment Regimen

SVR12 Rates

 

 n=40

 

Treatment-naïve=63%

 

pegIFN/RBV null responders=37%

 

12 weeks

 

 

 

Arm A

 

 

 

ABT-493 (200mg) + ABT-530 (120mg) once daily

 

100%

(n=40/40)

 

n=39

 

Treatment-naïve=64%

 

pegIFN/RBV null responders=36%

 

 

Arm B

 

 

 

ABT-493 (200mg) + ABT-530 (40mg) once daily

 

97%

(n=38/39)

 

 n=34

 

Treatment-naïve=85%

 

pegIFN/RBV treatment experienced=15%

8 weeks

Arm K

ABT-493 (300mg) + ABT-530 (120mg) once daily

 

97%

(n=33/34)

SURVEYOR-II (Genotype 2, Non-cirrhotic)

Number of Patients (n)/

Patient Population

Duration of Treatment

Treatment Arm

Treatment Regimen

SVR12 Rates

n=74

 

Treatment-naïve=88%

 

pegIFN/RBV treatment

experienced=12%

 

12 weeks

 

 

Arm A

 

 

 

ABT-493 (300mg) + ABT-530 (120mg) once daily

 

96%

(n=24/25)

Arm B

ABT-493 (200mg) + ABT-530 (120mg) once daily

100%

(n=24/24)

 

 

Arm C

 

 

ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily

100%

(n=25/25)

SURVEYOR-II (Genotype 3, Non-cirrhotic)

Number of Patients (n)/

Patient Population

Duration of Treatment

Treatment Arm

Treatment Regimen

SVR12 Rates

 

 

 

n=30

 

Treatment-naïve=90%

 

pegIFN/RBV treatment

experienced=10%

 

 

 

 

 

 

12 weeks

 

 

 

Arm D

 

ABT-493 (300mg) + ABT-530 (120mg) once daily

93%

(n=28/30)

 

n=30

 

Treatment-naïve=93%

 

pegIFN/RBV treatment

experienced=7%

 

Arm E

ABT-493 (200mg) + ABT-530 (120mg) once daily

93%

(n=28/30)

 

n=31

 

Treatment-naïve=90%

 

pegIFN/RBV treatment

experienced=10%

 

Arm F

 

ABT-493 (200mg) + ABT-530 (120mg) once daily + RBV (weight-based, 1000 or 1200mg) twice daily

94%

(n=29/31)

 

n=30

 

Treatment-naïve=93%

 

pegIFN/RBV treatment

experienced=7%

 

Arm G

 

ABT-493 (200mg) + ABT-530 (40mg) once daily

 

83%

(n=25/30)

 

About AbbVie's HCV Clinical Development Program 
AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection by investigating pan-genotypic (genotypes 1-6), all-oral, ribavirin-free, once-daily treatment options including shorter (8-12 weeks) duration therapy. AbbVie's investigational regimen includes ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor. ABT-493 and ABT-530 are currently being evaluated in Phase 2 studies with a multinational Phase 3 program in genotypes 1 through 6 initiated in November 2015.

ABT-493 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. ABT-493 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements 
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2014 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.  AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Poordad, F., et al. SURVEYOR-I: 98% – 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or Pegylated Interferon/Ribavirin Null-Responders with the Combination of the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530; Oral presentation #41; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13-17, 2015.

2 Wyles, D., et al. SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 2 Infection; Oral presentation #250; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13-17, 2015.

3 Kwo, P, et al. SURVEYOR-II: High SVR4 Rates Achieved With the Next Generation NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor ABT-530 In Non-Cirrhotic Treatment-Naïve and Treatment-Experienced Patients With HCV Genotype 3 Infection; Oral presentation #248; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13-17, 2015.

4 Poordad, F., et al. 100% SVR4 in HCV Genotype 1 Non-Cirrhotic Treatment-Naïve or -Experienced Patients With the Combination of ABT-493 and ABT-530 for 8 Weeks (SURVEYOR-I); Poster presentation #LB-14; presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco, November 13-17, 2015.

 

SOURCE AbbVie

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