Promethera Biosciences dosed the first patient in a phase 2a clinical study of HepaStem for patients with late stage nonalcoholic steatohepatitis, according to a press release.
The open-label study will evaluate safety and preliminary efficacy of HepaStem, a novel allogenic cell-based therapy for severe liver diseases including cirrhosis and pre-cirrhosis NASH.
“Today’s announcement has special significance for our company as NASH is increasingly going to be a significant value driver for our company,” John Tchelingerian, PhD, president and CEO of Promethera, said in the release. “With this trial we continue to pioneer the use of a cell-based therapy in severe liver diseases with existing unmet medical need and we are also among the few drug development organizations to tackle late-stage liver diseases relying on the strengths of our multi-modal approach.”
Researchers for the NASH study will enroll a minimum of 24 patients from eight European countries and expect to complete the study within the first half of 2020. Currently, HepaStem is also under evaluation in a phase 2a clinical study for acute-on-chronic liver failure.
“Moving HepaStem into clinical studies in NASH in addition to the ongoing clinical evaluation in acute-on-chronic liver failure, represents a significant milestone for our therapeutic development activities,” Etienne Sokal, MD, PhD, chief scientific and medical officer of Promethera. “While this first trial in NASH is conducted in Europe and is designed to deliver first clinical results early next year, the clinical development plan for HepaStem is going to expand into the US and Japan in the mid- to long-term.”