TARGET PharmaSolutions announced that Boehringer Ingelheim International has entered into a multi-year strategic partnership for TARGET-NASH.
TARGET-NASH is a longitudinal observational study that evaluates patients with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). To date, TARGET-NASH has enrolled 2,423 patients at 55 sites.
TARGET-NASH will enroll up to 15,000 patients over the coming years. TARGET-NASH is led by an academic steering committee chaired by Drs. Arun Sanyal, MD (Virginia Commonwealth University); Ken Cusi, MD (University of Florida), and Brent Tetri (St. Louis University).
Meg Powell, CEO of TARGET PharmaSolutions, stated, "We are very excited to have Boehringer Ingelheim join TARGET-NASH as an industry partner. We have exceeded our enrollment targets to date, and we are providing valuable real-world data and insight on NASH patients that will have a significant impact on the scientific understanding of the natural history and treatment modalities for NASH.
“ This data, combined with the TARGET-NASH biorepository and patient reported outcomes, will enable our collaborators to continue to increase their understanding of this growing disease."
Boehringer Ingelheim has a broad patient centric research and development program in metabolic diseases, encompassing diabetes as well as its contributing factors and complications. NASH is one of the company's key focus diseases in this therapy area with a high unmet medical need and no treatments currently available. Recently Boehringer Ingelheim has e.g. initiated a Phase II clinical trial program with its investigational NASH treatment BI 1467335.
The limited information available regarding NASH epidemiology is complicating the development of new medications.
TARGET-NASH has thus been initiated to provide an improved baseline against which to measure the impact of new therapies on medical co-morbidities, natural history, and hepatic, cardiovascular, and endocrine-associated outcomes ultimately enabling the development of better treatments for NASH patients.
The TARGET model organizes a community of stakeholders, including pharmaceutical manufacturers, key opinion leaders, regulatory agencies, investigators, and patient advocacy groups, around a specific disease to generate real world evidence about the natural history of the given disease, current treatment paradigm, and patient outcomes.
TARGET PharmaSolutions was formed in February, 2015 and currently has four disease communities: TARGET-NASH (nonalcoholic steatohepatitis), TARGET-PBC (primary biliary cholangitis), TARGET-HCC (hepatocellular carcinoma), and TARGET-IBD (inflammatory bowel disease).
The TARGET 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 11,000 patients and has generated data that has been used by physicians, payers, and regulatory agencies around the world.