RESEARCH TRIANGLE PARK – Durham-based TARGET PharmaSolutions, a clinical data company focused on real-world evidence in disease studies, has launched a new observational study of several inflammatory skin conditions, initially focusing on eczema.

The study, called TARGET-DERM, signed up its first participant in late January and will enroll up to 15,000 participants, including adult and pediatric patients, at up to 100 sites in the United States, Canada and Europe, the company announced in a news release.

TARGET Pharma logo

TARGET-DERM will create a research registry of patients with immune-mediated inflammatory skin conditions to assess the safety and effectiveness of current and future therapies. The study will eventually include the skin conditions hidradenitis suppurativa (painful bumps under the skin), alopecia areata (autoimmune-related hair loss), and vitiligo (loss of skin pigment).

“There are many critical, unanswered questions regarding the mechanisms underlying eczema and these other complex immune-mediated skin conditions,” said Emma Guttman-Yassky, M.D., co-chair of an academic steering committee that will lead the study.

Guttman-Yassky said TARGET-DERM is a unique opportunity to better understand the natural history of eczema and other diseases and to evaluate different treatment regimens, outcomes and adverse events across a large, diverse patient population.

“It is our hope that this research can better inform how these conditions are approached and ultimately improve the lives of the millions of people who suffer from them,” she said.

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Comparing ways to gather trial data

Guttman-Yassky is the Sol and Clara Kest Professor of Dermatology and Immunology and vice chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, N.Y. The other co-chair of the TARGET-DERM study is Diamant Thaçi, M.D., professor and head of the Comprehensive Center for Inflammation Medicine at the University of Lubeck in northern Germany.

TARGET-DERM will collect three years of retrospective data and five years of prospective data on its participants.  The data will also be connected to an extensive biorepository of patient cells and tissues that TARGET-DERM stakeholders can access for genomic studies and translational research.

The TARGET-DERM study design is disease-focused, not treatment-specific, allowing for continuous collection of natural history and outcomes data.  This includes patient-reported outcomes as new treatments enter the market and clinical programs evolve.

TARGET-DERM is the sixth disease study spearheaded by TARGET PharmaSolutions since the company’s founding in 2015. The other five are ongoing studies of nonalcoholic steatohepatitis, hepatocellular carcinoma, inflammatory bowel disease, primary biliary cholangitis and chronic hepatitis B.

The TARGET study model organizes a community of stakeholders, including key scientific leaders, regulatory agencies, pharmaceutical manufacturers, and patient advocacy groups, around a specific disease to generate real-world evidence about the natural history of the disease, the current treatment paradigm and patient outcomes.

TARGET PharmaSolutions also provides regulatory-grade data and analysis that may be used throughout the pharmaceutical development and commercialization process, including expanded indications and fulfillment of post-market studies.

The privately held company 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.