AbbVie Opens Global Phase 3 Studies of ABT-493/ABT-530 Hepatitis C Regimen

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AbbVie has started enrollment of a projected 1600 participants in 6 new international Phase 3 clinical trials evaluating a once-daily regimen of its investigational NS3/4A protease inhibitor ABT-493 and NS5A inhibitor ABT-530 for people with hepatitis C virus (HCV) genotypes 1 through 6, the company recently announced.

The EXPEDITION trials follow up on promising results from the Phase 2 SURVEYOR studies. As reported at the AASLD Liver Meeting in November, a 12-week course of ABT-493 plus ABT-530 cured 97%-100% of patients with genotype 1 in SURVEYOR-I, as well as 96%-100% of those with genotype 2 and 83%-94% of those with hard-to-treat genotype 3 in SURVEYOR-II. A shorter 8-week course was also highly effective against genotype 1.

The ENDURANCE trials will evaluate ABT-493 plus ABT-530 in hepatitis C patients with people with liver cirrhosis or advanced kidney disease.

Below is an edited excerpt from an AbbVie press release describing the new studies.

AbbVie Initiates Enrollment of Six Global Phase 3 Clnical Studies for Once-Daily, Pangenotypic Hepatitis C Regimen

-- The ENDURANCE and EXPEDITION Phase 3 clinical studies evaluate the investigational regimen of once-daily co-formulated ABT-493 and ABT-530 in patients with hepatitis C genotypes 1-6

-- New investigational regimen evaluates treatment durations of 12 weeks and as short as eight weeks in genotype 1 patients

North Chicago, Ill. -- January 11, 2016-- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the initiation of six global Phase 3 clinical studies evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus (HCV) regimen, ABT-493, an NS3/4A protease inhibitor, and ABT-530, an NS5A inhibitor, in patients with genotypes 1-6 (GT1-6) chronic HCV infection.

"We believe AbbVie's work in hepatitis C has contributed to the transformation of HCV care over the last few years," said Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie. "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."

The ENDURANCE and EXPEDITION studies are part of AbbVie's Phase 3 HCV pipeline program and will recruit approximately 1,600 patients globally, from over 250 study sites and in 27 countries. The primary efficacy endpoint of all six studies is rate of sustained virologic response at 12 weeks post-treatment (SVR12).

The four ENDURANCE studies evaluate AbbVie's investigational regimen in patients without cirrhosis for up to 12 weeks. ENDURANCE-1 compares SVR in GT1 chronic HCV infected patients who received ABT-493/ABT-530 treatment durations of 12 weeks and as short as eight weeks. ENDURANCE-2 evaluates AbbVie's investigational regimen versus placebo in GT2 chronic HCV infected patients. ENDURANCE-3 compares AbbVie's investigational regimen with sofosbuvir/daclatasvir in treatment-naive patients with GT3 chronic HCV infection. ENDURANCE-4 evaluates GT4-6 chronic HCV infected patients. 

The EXPEDITION trials evaluate AbbVie's investigational regimen for 12 weeks in difficult to treat patient populations with chronic HCV infection. EXPEDITION-1 evaluates AbbVie's investigational regimen in GT1, 2, 4-6 chronic HCV infected patients with compensated cirrhosis (Child-Pugh A). EXPEDITION-4 evaluates GT1-6 chronic HCV infected patients with severe renal impairment and end-stage renal disease, with or without compensated cirrhosis. 

More information on the studies is available at www.clinicaltrials.gov (NCT02604017, NCT02640482, NCT02640157, NCT02636595, NCT02642432, NCT02651194).

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 for 12 weeks, including eight week duration in genotype 1 patients. AbbVie's investigational regimen includes 300 mg ABT-493, an NS3/4A protease inhibitor, and 120 mg ABT-530, an NS5A inhibitor. 

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.

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.

1/21/16

Source

AbbVie. AbbVie Initiates Enrollment of Six Global Phase 3 Clnical Studies for Once-Daily, Pangenotypic Hepatitis C Regimen. Press release. January 11, 2016.