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Replies to post #200856 on Biotech Values
04/20/16 2:19 PM
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11/07/16 5:19 PM
11/11/16 8:43 AM
Enanta Pharmaceuticals, Inc. today 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:
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).
11/15/16 12:00 PM
Enanta Pharmaceuticals…today announced 98 percent (n=102/104) of chronic hepatitis C virus (HCV) infected patients with severe chronic kidney disease (CKD) achieved sustained virologic response following 12 weeks of treatment (SVR12) with AbbVie’s investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in the primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis, SVR12 was achieved in 100 percent (n=102/102) of severe CKD patients. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure.
…The EXPEDITION-4 study enrolled 104 patients with severe chronic kidney disease, including 85 patients (82 percent) who were receiving dialysis at enrollment and 20 patients (19 percent) who had compensated cirrhosis.
The study also included those who were not cured with previous treatment with sofosbuvir (SOF) plus ribavirin (RBV) or with interferon (IFN) plus RBV, with or without SOF (44 patients, 42 percent).
01/09/17 12:03 PM
