AbbVie tests new hepatitis C drug in Phase III trials
pharmafile | January 11, 2016 | News story | Research and Development |Â Â AbbVie, clinical trials, hepatitis C, phase IIIÂ
AbbVie has announced it has begun six global Phase III trials of its once-daily, ribavirin-free investigational hepatitis C virus regimen, ABT-493/ABT-530, in patients with genotypes 1-6 chronic infections.
The ENDURANCE and EXPEDITION studies will recruit approximately 1,600 patients globally, from over 250 study sites and in 27 countries. The primary endpoint of all six studies is rate of sustained virologic response at 12 weeks post-treatment.
AbbVie will hope the treatment can go on to be another blockbuster in the increasingly competitive market for hepatitis C virus (HCV) treatments. In this market its own product, Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir), goes up against Gilead Sciences’ Solvadi (sofosbuvir) and its successor Harvoni (ledipasvir-sofosbuvir), as well as Janssen’s Olysio (simeprevir). MSD is also hoping to get its own new product – the combination of elbasvir and grazoprevir – approved by regulators this year.
Having overcome questions over the safety of Viekira Pak last year, when the FDA linked it and another AbbVie HCV drug, Technivie, to serious liver damage, AbbVie will be keen to bring the new regimen to the market as quickly as possible.
Michael Severino, executive vice president, research and development and chief scientific officer, AbbVie, comments: “We believe AbbVie’s work in hepatitis C has contributed to the transformation of HCV care over the last few years. Our journey continues with the initiation of these Phase 3 studies, which we hope will help us meet the needs of an even broader range of patients living with hepatitis C.”
Trial details
The four ENDURANCE studies evaluate AbbVie’s investigational regimen in patients without cirrhosis for up to 12 weeks. ENDURANCE-1 compares the response in patients with chronic genotype 1 infections who received ABT-493/ABT-530 treatment for between eight and 12 weeks.
ENDURANCE-2 evaluates ABT-493/ABT-530 versus placebo in patients with chronic genotype 2 infections, while ENDURANCE-3 compares AbbVie’s investigational regimen with sofosbuvir/daclatasvir in treatment-naive patients with chronic genotype 3 infections. ENDURANCE-4 evaluates patients with chronic genotype 4-6 infections.
The EXPEDITION trials evaluate the regimen for 12 weeks in difficult to treat patient populations with chronic HCV infection. EXPEDITION-1 evaluates AbbVie’s investigational regimen in patients with chronic GT1, 2 and 4-6 infections who have cirrhosis. EXPEDITION-4 evaluates patients with chronic GT1-6 infections who have severe renal impairment and end-stage renal disease, with or without cirrhosis.
Joel Levy
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