Promethera Biosciences Announces Late-Breaking Data Presentation at EASL 2019 from World First Liver Stem Cell Clinical Trial in ACLF

Interim safety data together with early signals of efficacy will be
presented in oral presentation at The International Liver Congress™

MONT-SAINT-GUIBERT, Belgium–(BUSINESS WIRE)–Acute-on-Chronic Liver Failure (ACLF) or acute decompensation (AD) at
risk of developing ACLF has been selected by the European Association
for the Study of the Liver (EASL) for an oral presentation, by the
principal investigator (Prof. F. Nevens, KULeuven, BE) during the
plenary general session at The International Liver Congress^™ (ILC)
2019 being held April 10-14, 2019, in Vienna, Austria.

HepaStem consists of liver stem cells that are obtained from ethically
donated healthy human organs and expanded in GMP culture conditions. The
product candidate is currently being evaluated in a Phase 2a clinical
trial in acute on chronic liver failure (ACLF) and Acute decompensation
(AD).

“We are very pleased with the interim data received from the HepaStem
trial so far. We were able to obtain a safe dosing regimen in both ACLF
and AD patients, and we continue to evaluate the safety of this
ground-breaking treatment to achieve a thorough and robust safety
profile,” said Etienne Sokal, M.D., Ph.D., Promethera’ s Chief
Scientific & Medical Officer. “Promethera is pioneering the use of
liver-derived stem cells for the treatment of ACLF and non-alcoholic
fatty liver disease (NASH), and these preliminary safety results are
very encouraging as we continue to advance HepaStem in the clinic.”

In the study, single and repeated infusions of HepaStem were shown safe
in this AD/ACLF patient population. In addition, the Model for End Stage
Liver Disease score (MELD), Child-Pugh score and bilirubin levels, three
indicators of liver disease severity, had decreased along the trial in
treated patients, which is regarded as an encouraging sign of efficacy.
To download the abstract, please click here.

About Promethera Biosciences

Promethera Biosciences is a global innovator in liver therapeutics whose
mission is to bring life-saving treatments to reduce the need for liver
transplantation. Our lead clinical program, derived from our patented
cell technology platform HepaStem, is designed to benefit from its
immune-modulatory and anti-fibrotic properties. In addition to our
cell-based pipeline we develop antibody technologies, such as the
anti-TNF-R1 antibody Atrosimab, to complement and diversify our
therapeutic options. We are a team of international experts operating
out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA,
Tokyo, Japan and Basel, Switzerland.

Promethera®, HepaStem®, H2stem®, are all registered trademarks of the
PROMETHERA group.

Contacts

Promethera Biosciences SA For media:
Alexandra
Schiettekatte
[email protected]
Web:
www.promethera.com

MacDougall
Mario
Brkulj or Shai Biran, Ph.D.
+49 89 2420 9345
or +1 781-235-3060
[email protected]