Market Overview

ENYO Pharma Strengthens Its Leadership Team with a NASH Expert and Announces that its Phase Ib Trial in Chronic HBV Infected Patients is on Track with its FXR Agonist EYP001

  • Appointment of Raphaël Darteil as VP Non-Clinical Development &
    Product Profiling
  • EYP001 study 103 in chronic HBV patients set to deliver results
    in Q2 2018
  • Two Phase IIa studies with EYP001 in CHBV and in NASH to start
    in H2 2018

ENYO Pharma SA, a privately held biopharmaceutical company developing
innovative new drug candidates by mimicking virus strategies to modulate
host cellular functions, has today announced that it is strengthening
its leadership team with the appointment of a VP Non-Clinical
Development & Product Profiling. ENYO Pharma also confirms that its
Phase Ib trial evaluating the safety of EYP001 in chronic HBV infected
patients is progressing well in Europe and in the Asia-Pacific region
and is set to deliver its results in Q2 2018.

Jacky Vonderscher, Chief Executive Officer of ENYO Pharma commented: "We
are delighted to welcome an expert in NASH and in Nuclear Receptors who
will add important new skills and experience to our Executive Team and
help us optimizing all aspects of our development plans. Now that we
have demonstrated safety in Healthy Subjects and clear target engagement
for our FXR agonist EYP001 in Chronic HBV infected patients, we are
planning to start two Phase IIa studies, one in CHBV patients and one in
NASH patients, in H2 2018. NASH is a valuable additional opportunity for
our lead compound and significantly strengthens our portfolio as FXR
agonism has already been validated to play an important role in NASH.

Dr. Raphaël Darteil, Vice-President Non-Clinical Development &
Product Profiling

As a PhD with more than 20 years of R&D and portfolio management
experience in pharma and biotech industries, Raphaël brings to ENYO
Pharma his scientific expertise in metabolic diseases and especially in
NASH as well as in the field of Nuclear Receptors. During the last 7
years, he was Executive VP, Chief Operating Officer and member of the
Management Board of Genfit. Prior to this, Raphaël held various
positions in the department of Gene Therapy of Aventis both in France
and in the United States. He holds a PhD in Molecular and Cellular
Biology from the University Claude Bernard Lyon I.

Study 103 evaluating the Safety of EYP001 in CHBV patients set to
deliver results in Q2

A phase Ib multicenter, randomized, double-blind, placebo-controlled
study in chronic HBV patients was initiated at the end of 2017 to
determine the safety and tolerability of daily oral administration of
EYP001 over 4 weeks. The study is performed in Poland, Netherlands,
Thailand and Australia. The study explores the effect of various EYP001
doses given alone and compared to Entecavir (Part A) or in combination
with Peg-INFα2a (Part B). "We are looking forward to the preliminary
results from this important dose-ranging study as they will support and
validate the design of the phase II study in CHBV patients planned to
start in H2 2018"
commented Pietro Scalfaro, Chief Medical Officer
of ENYO Pharma.

About EYP001 and FXR

ENYO Pharma SA has licensed a family of non-bile acid farnesoid X
nuclear hormone receptor (FXR) agonists from Poxel SA and holds
worldwide exclusive rights on these patented compounds for any
indication. EYP001 is a synthetic small non-bile acid molecule, acting
on the host target nuclear receptor FXR, and is being developed for the
oral administration in patients with Chronic Hepatitis B Viral
infections and in patients having NASH. EYP001 interferes with HBV
replication in the liver at post-entry steps likely impacting
transcriptional activity of cccDNA. Activation of FXR function by EYP001
offers the potential for durable suppression of the virus with higher
cure rates. The class of FXR agonists is gaining attention as potential
therapeutic agents in hepatobiliary and metabolic diseases. FXR
activation has a favorable effect on liver growth and regeneration and
has been shown to prevent and resolve liver fibrosis in rodents and
humans. FXR has multiple activities required for viral
replication/persistence and FXR regulates several metabolic pathways. It
controls the fate of bile acids in the liver and intestine, it
influences the insulin sensitivity of tissues where it is highly
expressed and it impacts lipid metabolism. Several FXR agonists are
currently in development for the treatment of Non-Alcoholic
SteatoHepatitis (NASH).

About HBV

According to the WHO, over 350 million people chronically infected with
the hepatitis B virus are awaiting treatment, half of them in Asia.
Despite progress with vaccine coverage, close to 300 million people will
remain chronically infected in the 2030s, putting them at major risk of
developing cirrhosis and liver cancer. Current standard of care drugs
approved for the treatment of CHB infections (PEG-Interferon and
nucleot(s)ides like Tenofovir or Entecavir) effectively suppress the
virus presence in blood but are seldom curing patients as the virus
continues its destructive course in the liver cells of these patients
through its embedded cccDNA.

About NASH

NASH is the most common liver disorder in Western countries and results
in liver fat accumulation leading to inflammation and hepatocyte injury.
It is estimated that more than 5% of the population has an advanced
NASH. Its main consequence is liver fibrosis, cirrhosis and
hepatocellular carcinoma. Currently no treatment exists for this disease
which represents an important challenge.

ENYO Pharma's technology and pipeline -

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