High Point Clinical Trials Center LLC, the largest independent clinical research unit in North Carolina, announced its participation in the NASH PASS network. NASH PASS is organized and managed by metabolic disease specialist CRO ProSciento.
Who is High Point Clinical Trials Center LLC (HPCTC)?
Founded in 2009, HPCTC claims to be the largest clinical research unit in North Carolina. They conduct a full range of clinical trial phases with an emphasis on Phase I/II translational medicine studies, including first-in-human, clinical proof of concept and the traditional IND/NDA-enabling clinical pharmacology programs for Contract Research Organizations (CRO), as well as directly with industry sponsors worldwide. TrialSite News estimates HPCTC employs between 75 to 100.
HPCTC’s facility contains two fully independent research units, configurable to specific study needs. With more than 100 beds, their configurations range from intimate, safety focused smaller dedicated spaces for first-in-human studies to larger pharma co-kinetic studies, and they even have a separate unit for tobacco/nicotine harm reduction evaluation studies.
What is ProSciento’s NASH PASS?
This program has been designed and developed for industry sponsors (biopharmaceutical companies) investing in NASH portfolios. The NASH PASS program marries select qualified sites and a proprietary methodology to improve enrollment outcomes in NASH clinical trials. Part of the proprietary methodology will include a “NASH PASS protocol” to identify individuals eligible for enrollment into clinical trials of therapeutic candidates to treat NAFLD (non-alcohol fatty liver disease and NASH steatohepatitis).
As a NASH PASS partner, HPCTC will contribute to the expansion and enrichment of its database of prospective clinical study participants evaluated for NAFLD/NASH to utilize a combination of elastography (Fibroscan), proprietary algorithms and non-invasive biomarker testing.
ProSciento reports that clinical trial participant identification and recruitment continues to be a challenge in NASH clinical programs, impacting cost and timelines. Consequently, the specialized CRO has developed what they position as a unique, science-driven solution to considerably improve patient recruitment efforts. For NASH studies, clinical trial investigational sites working with ProSciento utilize their NASH PASS protocol to identify patients with a high probability of steatosis or steatohepatitis prior to imaging techniques or biopsies.
The noninvasive methodology utilizes vibration controlled transient elastography (VCTE) Fibroscan proprietary clinical algorithms and state-of-the-art metabolomic testing. The outcome is a wider number of eligible patients, detailed enrichment data for the enrollment phase of a NASH clinical trial and far fewer screen failures during expensive imaging procedures.
The two organizations appear to be well-suited to work together, possessing significant synergies. ProSciento, a niche CRO focusing on metabolic diseases including NASH, conducts marketing campaigns worldwide to leverage its capabilities, expertise and network of sites. Its NASH PASS appears to include unique methodologies to help industry sponsors with their NASH drug pipeline clinical work. HPCTC, a clinical investigational site of significant size and capability in North Carolina, introduces its staff expertise and rigorous metabolic testing techniques not to mention patient database to considerably add to the NASH PASS network of sites, ultimately contributing to ProSciento’s ability to market NASH clinical outsourcing services to industry sponsors.
Based in the San Diego, California, area, ProSciento has positioned itself in the crowded CRO market as a specialized niche player with a focus on NASH, diabetes, obesity and related metabolic diseases. Founded in 2003, they have conducted more than 280 clinical projects for diabetes, NASH and obesity and supported the development of many approved metabolic drugs and devices on the market globally. With an employee count between 100-150, they publish ongoing clinical trials they service.
ProSciento is led by Marcus Hompesch, MD, who has served as CEO since the inception. He is the editor-in-chief of the journal Endocrinology, Diabetes & Metabolism, a Wiley production. Prior to leading ProSciento, Dr. Hompesch was Chief Operating Officer of Profil Institut für Stoffwechselforschung GmbH and, before that, was founder and Chief Executive Officer of the medical technology company Med.IQ. He is an author of more than 100 publications, including peer-reviewed journals and editorials, and is a regular peer reviewer for scientific journals relevant to metabolic diseases. He is also an editor and co-author of the textbook Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development.