Allergan, a leading global biopharmaceutical company, has announced that it 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 nonalcoholic fatty liver disease (NAFLD) or nonalcoholic 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 has a strong commitment to developing treatments for NASH and is pleased to sign on with TARGET-NASH.

"Allergan is focused on identifying, developing and bringing forward innovative treatments for patients with significant unmet medical needs, such as non-alcoholic steatohepatitis (NASH)," said David Nicholson, Chief Research & Development Officer, Allergan. "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."

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

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."

Non-Alcoholic Steatohepatitis (NASH) is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage. The inflammation can lead to fibrosis (scarring) of the liver and eventually lead to complications such as cirrhosis, portal hypertension, liver cancer, and eventual liver failure.

NAFLD and NASH affect approximately 30% and 5%, respectively, of the US population and NAFLD affects more than 20% of the population worldwide. NASH is the fastest growing cause of liver cancer and liver transplant in the US. Liver cancer among women grew by 3.8% (95% CI=3.4 to 4.1) per year over the past five years, replacing thyroid cancer as the most rapidly increasing cancer incidence among women. The increasing prevalence of NASH is related to the growing obesity epidemic and the disease is often diagnosed in patients who have diabetes, high cholesterol or high triglycerides. There is currently no approved treatment for NASH.