Immuron Completes Phase II NASH Clinical Trial Recruitment
Released
Released
Announcement PDF
PRESS RELEASE: 20 FEBRUARY 2017
Immuron Completes Phase II
NASH Clinical Trial Recruitment
• NASH Phase II Clinical Trial Fully Recruited
• 120 Patients Randomized
• NASH Trial Results Expected in Q4 2017
ABN: 80 063 114 045
Suite 1, 1233 High Street, Armadale, Victoria AUSTRALIA 3143
www.immuron.com I Phone: + 61 (0)3 9824 5254 I Facsimile: + 61 (0)3 9822 7735
Immuron Completes Phase II NASH
Clinical Trial Recruitment
Melbourne, Australia, February 20th, 2017: Immuron Limited (ASX: IMC), an Australian biopharmaceutical
company focused on oral immunotherapy utilizing polyclonal antibody products to target immunemediated diseases, today announced that the Company’s IMM-124E Phase II clinical trial for the
treatment of NASH (Non-Alcoholic Steatohepatitis) has successfully reached its full recruitment milestone
of 120 randomized patients.
The Phase II, multicenter, double blind randomized clinical study is designed to assess the safety and
effectiveness of IMM-124E for the treatment of NASH. The effectiveness element is primarily focused on
evaluating the effect of IMM-124E on patients with NASH, compared to placebo, after six (6) months of
treatment. The clinical trial protocol was developed by Immuron in partnership with its Scientific Advisory
Board led by Dr. Arun Sanyal of Virginia Commonwealth University (USA). The study is conducted in the
United States, Australia, and Israel.
This effectively concludes the recruitment process of the NASH Phase II clinical trial, although due to strong
enrollment demand, the existing 12 patients in screening will be allowed to proceed to randomization,
pending their respective eligibility. As previously announced, the Company expects to report the topline
results of the clinical trial in the second half of 2017.
NASH, a severe form of non-alcoholic fatty liver disease (NAFLD) that causes liver inflammation and
damage, afflicts approximately 16 million of people in the United States each year. Currently, no drug
has received FDA approval for the treatment of NASH, leading physicians to treat the disease by
addressing underlying conditions such as diet and obesity. For this reason, NASH is widely considered a
tremendous market opportunity for pharmaceutical and biotechnology companies.
Immuron’s CEO Mr Thomas Liquard commented:
“This significant milestone results from the efforts of many over the past three years. I would like to
communicate my profound gratitude to Immuron’s clinical team for their tireless effort, and also
to our valued principal investigators and their teams, for their dedication to the IMM-124E clinical
trial. IMM-124E has a unique multifactorial mechanism of action (MOA) that we believe possesses
ABN: 80 063 114 045
Suite 1, 1233 High Street, Armadale, Victoria AUSTRALIA 3143
www.immuron.com I Phone: + 61 (0)3 9824 5254 I Facsimile: + 61 (0)3 9822 7735
a unique combination of safety and efficacy attributes which have the potential to greatly
improve outcomes for NASH patients worldwide.”
Dr Dan Peres, Immuron’s Head of Medical, added:
“We are thrilled that Immuron's clinical team, in partnership with the investigators and site staff, have been
able to significantly improve the study’s recruitment rate over the past few months to now reach full
recruitment. I would like to especially thank our Lead Principal Investigator, Dr. Arun Sanyal, for his
leadership throughout the trial. We look forward to continuing our clinical work with Dr. Sanyal and other
site principal investigators through the completion of the trial and beyond.”
- - - END - -
COMPANY CONTACT:
RELATIONS:
Thomas Liquard
IMMURON MEDIA
John Beveridge
Chief Executive Officer
Communications Ph: +61 (0)3 9824 5254
thomasliquard@immuron.com
Monsoon
Ph: +61 (0)3 9620 3333
johnb@monsoon.com.au
ABOUT IMMURON:
Immuron Ltd (ASX:IMC; OTCQB:IMROY) is a microbiome company focused on developing and commercialising oral immunotherapeutics
for the treatment of many gut mediated diseases. Immuron has a unique and safe technology platform that enables a shorter development
therapeutic cycle. The Company currently markets and sells Travelan® for the prevention of travellers’ diarrhoea, whilst its lead product
candidate IMM-124E is in Phase 2b clinical trials for NASH and ASH. These products together
with
the
Company’s
other
preclinical
immunotherapy pipeline products targeting immune-related diseases currently under development, will meet a large unmet need in the
market. For more information visit: http://www.immuron.com
FORWARD-LOOKING STATEMENTS:
Certain statements made in this release are forward-looking statements and are based on Immuron’s current expectations, estimates
and projections. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar
expressions are intended to identify forward-looking statements. Although Immuron believes the forward-looking statements are based
on reasonable assumptions, they are subject to certain risks and uncertainties, some of which are beyond Immuron’s control,
including those risks or uncertainties inherent in the process of both developing and commercialising technology. As a result, actual
results could materially differ from those expressed or forecasted in the forward-looking statements. The forward-looking statements
made in this release relate only to events as of the date on which the statements are made. Immuron will not undertake any
obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or
unanticipated events occurring after the date of this release except as required by law or by any appropriate regulatory authority.
ABN: 80 063 114 045
Suite 1, 1233 High Street, Armadale, Victoria AUSTRALIA 3143
www.immuron.com I Phone: + 61 (0)3 9824 5254 I Facsimile: + 61 (0)3 9822 7735
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