Allergan will collaborate with TARGET PharmaSolutions, a clinical data company focused on real world evidence, on its TARGET-NASH study.

TARGET-NASH is a five-year longitudinal observational study that looks at patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). TARGET-NASH was launched in advance of related drug approvals in order to help facilitate a greater understanding of the impact of NASH and future treatment options.

Allergan entered into a clinical trial agreement with Novartis to conduct a Phase IIb study, involving the combination of a Novartis’ FXR agonist and Allergan’s cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH) 

David Nicholson, Chief Research & Development Officer, Allergan, said, "NASH is an emerging healthcare crisis affecting both adults and children. This unique collaboration will help to further our collective understanding of the disease, effective modes of treatment and outcomes across the spectrum of patient groups."

15,000 enrolled by 2021

TARGET-NASH is a unique program as it involves academia, industry, regulatory agencies and the NASH/NAFLD community. TARGET-NASH’s first patient enrolment occurred August 1, 2016, and over the course of the five-year study the program looks to enrol 15,000 adults and children with NAFLD or NASH.

"The study design is disease focused, not drug specific"

The study design is disease focused, not drug specific, allowing for continuous acquisition of natural history and outcomes data as new drugs enter the market and clinical treatment paradigms evolve.

HCV-target inspired

TARGET PharmaSolutions’ TARGET study model is based on the success of HCV-TARGET, a case study in Hepatitis C. Formed in 2011 by Drs Michael Fried, MD (University of North Carolina) and David Nelson, MD (University of Florida), HCV-TARGET has enrolled over 10,000 patients and has generated data that has been used by physicians, payers, and regulatory agencies around the world.

"TARGET-NASH is critical for the scientific and regulatory community as we prepare for new agents for the treatment of NASH," said Arun Sanyal, MD, Co-Chair, TARGET-NASH Steering Committee.

"In the immediate term, it will give us a critical understanding of NASH diagnosis and management in the real world across multiple populations. In the longer term, it is the perfect platform to have a deep understanding of the safety and effectiveness of these new agents across populations not included or underrepresented in Phase 3 clinical trials."