SHANGHAI, Dec. 2, 2021 /PRNewswire/ -- Hepagene
Therapeutics, Inc, a clinical stage biopharmaceutical company
focusing on innovative therapies for patients with liver diseases,
today announced that it has screened the first patient in the
USA for the RISE study, a Phase
IIa clinical trial of HPG1860 in patients with non-alcoholic
steatohepatitis (NASH). HPG1860, a non-bile acid, potent,
selective and full farnesoid X receptor (FXR) agonist, is under
development for the treatment of NASH and cholestatic
hepatitis.
"We are thrilled to initiate the HPG1860 phase IIa RISE trial in
NASH patients. We have recently reported positive phase I data of
HPG1860 at the 2021 AASLD meeting. HPG1860 displayed a benign safety
profile with robust target engagement through C4 reduction and
FGF19 activation." Said Que Liu M.D. Ph.D., Chief Medical
Officer of Hepagene. "We look forward to assessing safety and
efficacy of HPG1860 in the RISE study and advancing HPG1860 as a
potential therapy for NASH patients."
The RISE study is a 12-week, randomized, double-blind,
placebo-controlled multi-center Phase IIa clinical trial evaluating
the safety, tolerability, and efficacy in NASH patients who receive
placebo or 3mg, 5mg and 8 mg doses of HPG1860. The trial will
enroll 80 patients (20 patients/cohort) in the USA. Each study drug (placebo or HPG1860) will
be given once daily by oral administration. The primary endpoint
for the study is the safety and tolerability of HPG1860, while the
secondary endpoint is to assess changes in liver fat content (LFC)
after treatment with HPG1860. Other endpoints include changes in
biomarkers and pharmacokinetic profile of HPG1860 in NASH
patients.
"Initiating RISE phase IIa trial in NASH patients represents an
important milestone for Hepagene." said Michael X. Xu Ph.D., CEO of
Hepagene. "Our focus is on liver diseases, and we anticipate
multiple novel mechanism compounds for both NASH and HBV entering
clinical trials in the near future. At the same time, we are
actively advancing pipelines utilizing in house developed novel
siRNA delivery platform."
About HPG1860
HPG1860 is an investigational potent and selective full FXR
agonist with a non-bile acid scaffold. Through regulation of gene
expression of bile acids, FXR serves as a key controller of bile
acid homeostasis. HPG1860 exhibited strong target engagement and
benign safety profile in both preclinical research and Phase I
clinical trial.
About NASH
Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the
most common liver disease worldwide, with an approximate prevalence
of 20-30% in western countries. An estimated 20-25% of these patients
will further progress to NASH, marked by steatohepatitis,
ballooning and inflammation. Typically, NASH is accompanied with
liver fibrosis that can progress to liver cirrhosis and
hepatocellular carcinoma. NASH
is currently ranked the second most common reason for liver
transplants in the USA.
About Hepagene Therapeutics, Inc.
(www.hepagene.com)
Hepagene Therapeutics, Inc. devotes its efforts towards
discovering, developing and delivering innovative medicines that
help patients prevail over liver diseases, especially non-alcoholic
steatohepatitis (NASH), chronic Hepatitis B infection, and liver
cancer.
For further information, please contact:
Ms. Gu
Investor@hepagene.com
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SOURCE Hepagene Therapeutics, Inc.