High Point Clinical Trials Center (HPCTC) has entered into a three-year collaboration with ProSciento, a CRO exclusively focusing on metabolic diseases, to join as a NASH PASS site partner.

ProSciento’s NASH PASS programme blends select qualified clinical trial sites and a methodology to improve enrollment of candidates to treat NAFLD (non-alcoholic fatty liver disease) and NASH (steatohepatitis) in clinical trials.

Through the partnership, HPCTC plans to use the NASH PASS protocol to identify eligible candidates for enrollment into clinical trials.

HPCTC’s clinical research studies mainly focus on Phase I/II Proof of Concept clinical pharmacology research.

As a NASH PASS partner, HPCTC contributes to the expansion of its database of clinical study participants examined for NAFLD/NASH by utilising a blend of transient elastography (Fibroscan), proprietary algorithms, and non-invasive biomarker testing..

HPCTC vice-president of clinical pharmacology services Clay Dehn said: “This collaboration is an ideal alignment between best in class organizations focused on providing early clinical proof of concept study design and execution in the NAFLD and NASH disease space.

“Our consultative approach ensures that the correct endpoints are incorporated into the study design and with ProSciento we are well-positioned to support enriched clinical enrollment for those studies”

HPCTC president Dr. Lorraine M Rusch said: “NAFLD/NASH represents a rapidly growing and evolving field of biopharmaceutical R&D, with a sizable number of drug candidates advancing through the various stages of preclinical and clinical development.

“These much-needed efforts will spur rapid recruitment of patients into clinical trials which directly translates into novel pharmaceutical products and new methodologies for earlier treatment of this emerging metabolic epidemic,” added, President of HPCTC.”

Founded in 2009, HPCTC is an independent clinical research unit. It conducts all phases of clinical trials special focused on Phase I/II translational medicine studies including first-in-human, clinical proof of concept and the traditional IND/NDA-enabling clinical pharmacology programmes.