Clinical data company TARGET PharmaSolutions of Chapel Hill has entered into a new strategic partnership with a major pharmaceutical company and extended existing partnerships with two others to study a serious liver disease.
TARGET said it has begun a multi-year partnership with Boehringer Ingelheim International of Ingelheim, Germany, for a study of patients with nonalcoholic fatty liver disease (NAFLD) or a more serious form of the disease, nonalcoholic steatohepatitis (NASH). The study, called TARGET-NASH, has enrolled 2,423 patients at 55 sites and will enroll up to 15,000 patients over the coming years.
“We are very excited to have Boehringer Ingelheim join TARGET-NASH as an industry partner,” TARGET CEO Meg Powell said in a news release. “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.”
Data from the longitudinal study, combined with tissue biorepository and patient-reported outcomes, “will enable our collaborators to continue to increase their understanding of this growing disease,” Powell said.
Other big pharmaceutical companies also weigh in
Two other TARGET-NASH partnerships with Bristol-Myers Squibb and Intercept, both based in New York, have been extended to multi-year agreements.
TARGET declined to give the length or revenue value of the three partnerships, but the agreements are spurring company growth. TARGET began this year with about 20 employees but has more than doubled its workforce to about 50 and expects to have 70 employees by the end of 2018, Powell said.
“We continue to be pleased at the uptake that the additional renewals and addition of Boehringer Ingelheim represent,” Powell said. “Real-world evidence continues to be so critical in advancing drug development and ultimate patient outcomes. TARGET is pleased that its real-world collaborative platform is providing a way to facilitate drug development and ultimately move the entire field forward.”
NASH is a key focus of Boehringer Ingelheim, which recently initiated a Phase 2 clinical trial program for its investigational NASH treatment BI 1467335.
TARGET said limited information about the epidemiology of NASH is complicating the development of new medications. TARGET-NASH aims to provide an improved baseline for measuring 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 company said.
In addition to TARGET-NASH, the company has three other disease communities for the study of primary biliary cholangitis, hepatocellular carcinoma and inflammatory bowel disease.
TARGET targets stakeholders for real-world evidence
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 disease, current treatment paradigms and patient outcomes.
The model is based on HCV-TARGET, a case study in hepatitis C. Formed in 2011 by Michael Fried, M.D., of the University of North Carolina at Chapel Hill and David Nelson, M.D., of the University of Florida, HCV-TARGET has enrolled over 11,000 patients and generated data used by physicians, payers and regulatory agencies around the world.
TARGET was formed in February 2015. The North Carolina Biotechnology Center awarded the company a $500,000 Strategic Growth Loan in 2016, but “we have been fortunate to not have to draw on this line of credit to date,” Powell said.
TARGET is backed by a Series A funding round completed in 2016 and led by Raleigh-based REX Health Ventures, the venture capital arm of UNC REX Healthcare, with participation by VentureSouth of Greenville, S.C., and local angel investors.
(C) N.C. Biotechnology Center