PANASH Trial will Evaluate Safety and Early Signs of Efficacy of
HepaStem® in F3- F4-grade NASH Patients
MONT-SAINT-GUIBERT, Belgium & TOKYO–(BUSINESS WIRE)–Promethera
Biosciences SA, a global innovator in cell-based medicines and liver
diseases, today announced the dosing of a first patient in a Phase 2a
clinical study for the company’s HepaStem development program in
patients with late stage non-alcoholic steatohepatitis (NASH). The
multicenter, open-label PANASH study will evaluate the safety and
preliminary efficacy of Promethera’s investigational drug HepaStem, a
novel allogenic cell-based therapy for severe liver diseases, in
patients with cirrhotic and pre-cirrhotic NASH. The study will enroll a
minimum of 24 patients via centers in 8 European countries. The
completion of the trial is expected for H1 2020.
“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. 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,” said Etienne Sokal, M.D., Ph.D., Chief
Scientific & Medical Officer of Promethera.
“Today’s announcement has special significance for our company as NASH
is increasingly going to be a significant value driver for our company.
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,”
said John Tchelingerian, Ph.D., President and CEO of Promethera.
“Overall, Promethera continues to make tangible progress in its mission
to bring life-saving treatments to liver disease patients and to reduce
the need for liver transplantation.”