Enanta Pharma (ENTA) Affirms Publication of Strong Data from G/P Treatment in HCV (ABBV)

November 11, 2016 8:11 AM EST

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Enanta Pharmaceuticals, Inc. (Nasdaq: ENTA) announced that AbbVie has published high SVR12 rates across all major chronic hepatitis C virus (HCV) genotypes with 8 weeks of treatment with its investigational, pan-genotypic regimen consisting of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). In more than 700 chronic HCV patients without cirrhosis who were infected with one of genotypes 1-6 (GT1-6) and were new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR12), regardless of baseline viral load. The rate of virologic failure was 1 percent (n=9/711).

Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie. G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg) and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets.

These new top-line data comprise results from the eight week arms of three registrational clinical trials evaluating the efficacy and safety of G/P – the ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) studies. Across the eight week arms of all three studies, there were no discontinuations due to adverse events (AEs). The most common AEs, occurring at a rate greater than 10 percent across these arms were headache and fatigue; and there were no AEs in any study arm at a rate greater than 20 percent. No clinically relevant laboratory abnormalities, including ALT changes, were observed.

“The SVR rates in these studies are an important step toward providing an 8-week treatment option to HCV-infected patients without cirrhosis who are new to treatment,” commented Jay R. Luly, Ph.D. “We look forward to AbbVie’s regulatory approval filings planned in the U.S. by the end of this year and in Europe and Japan in early 2017.”

Overview of preliminary results across the three studies of G/P:

Study Name Patient Population

TreatmentDuration

TreatmentRegimen

SVR12 Rate
ENDURANCE-1

GT1 without cirrhosis, new to treatment ornot cured with previous IFN-basedtreatments (pegIFN +/- RBV or SOF/RBV +/-pegIFN), and patients co-infected with HIV-1

8 week G/P 99%

(n=348/351)

ENDURANCE-3

GT3 without cirrhosis,new to treatment

8 week G/P

95%

(n=149/157)

SURVEYOR-2(Part 4)

GT2, 4, 5, or 6 without cirrhosis, new totreatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV orpegIFN/SOF)

8 week G/P 97%

(n=196/203)

G/P is an investigational, pan-genotypic regimen currently being evaluated in a registrational clinical development program, and its safety and efficacy have not been established. Additional data from the ENDURANCE-1 and SURVEYOR-2 (Part 4) studies will be presented at The Liver Meeting®, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston. Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.

G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure with 8 weeks of treatment for HCV patients without cirrhosis and new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3 patients who were not cured with previous DAA treatment and those with chronic kidney disease, including patients on dialysis.

AbbVie’s clinical development program for (G/P) was designed to investigate a faster path to virologic cure for all major HCV genotypes (GT1-6), with the goal of addressing treatment areas of continued unmet medical need. Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

About the ENDURANCE and SURVEYOR Studies

ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) are open-label, multi-center, registrational studies evaluating the safety and efficacy of G/P across all major chronic HCV genotypes (GT1-6). The primary efficacy endpoint for all studies is SVR12.

ENDURANCE-1 is a randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT1 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN +/- RBV or SOF/RBV +/- pegIFN), including patients co-infected with HIV-1.

ENDURANCE-3 is a partially randomized study designed to evaluate the safety and efficacy of 8 and 12 week treatment durations of G/P in patients with GT3 chronic HCV infection without cirrhosis and new to treatment. The study has an additional active comparator arm of 12 weeks of sofosbuvir + daclatasvir (SOF+DCV). Additional data from study arms will be presented at an upcoming scientific congress.

SURVEYOR-2 (Part 4) is a single-arm study evaluating 8 week treatment duration of G/P in patients with GT2, 4-6 chronic HCV infection without cirrhosis and new to treatment or not cured with previous IFN-based treatments (pegIFN, SOF/RBV or pegIFN/SOF).



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