NASH Clinical Trial Surpasses 25% Patient Recruitment Level
Released
Released
Announcement PDF
NASH Clinical Trial Surpasses 25% Patient Recruitment Milestone
Wednesday 18th November 2015 – Melbourne, Australia: Australian biopharmaceutical Company Immuron
Limited is pleased to announce that the Company’s IMM-124E Phase IIb Clinical Trial for the treatment of
NASH (Non-Alcoholic Steatohepatitis) has successfully passed its 25% recruitment milestone with 35 patients
having been successfully randomised into either arm of the trial.
The Company is also pleased to announce that no significant treatment adverse events have been reported.
Immuron continues to drive its NASH clinical trial recruitment to meet its enrollment goal of 120 biopsyproven NASH subjects by June 2016. Patients who qualify for the clinical trial are randomised into 3 groups
of patients who receive either a 600 mg or 1200 mg dose of IMM-124E, or Placebo, 3 times daily.
Immuron now has a total of 22 active clinical study sites across the USA, Australia and Israel, including 3
additional sites initiated in the past 3 months. The Company has also targeted 3 additional sites in the US
which should start enrolling patient by early 2016.
Immuron’s Senior Vice-President of Medical, Dr. Dan Peres, commented:
“We are extremely pleased with the way the NASH clinical trial patient recruitment has progressed over
the past few months. We will continue to drive patient recruitment forward to achieve a fully recruited
trial by June 2016".
In December 2014, the Company announced the launch of the NASH Phase IIb multinational multicenter
randomised double blind placebo controlled clinical trail of its proprietary compound IMM-124E for the
treatment of NASH, with the first patient randomised in February 2016. The protocol was jointly developed
by Immuron's Scientific Advisory Board led by Prof. Arun Sanyal of Virginia Commonwealth University, USA.
The primary endpoint of the NASH study is to prove safety and efficacy of IMM-124 in the reduction of fatty
liver, as confirmed by MRI, and in the reduction of liver enzymes (Alanine transaminase - ALT) over a six
month treatment period.
Company Contact:
Thomas Liquard
Chief Executive Officer
AUS Ph: +61 (0)3 9824 5254
thomasliquard@immuron.com
Immuron US Investor Relations:
Jon Cunningham
RedChip Companies, Inc.
US Ph: +1 (407) 644 4256, (ext. 107)
jon@redchip.com
About Immuron
Immuron Ltd (ASX: IMC; OTCQB: IMROY) is a microbiome company focused on developing and commercialising oral
immunotherapeutics for the treatment of a 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/
Suite 1, 1233 High Street
Armadale, Victoria
AUSTRALIA
3143
www.immuron.com
ABN: 80 063 114 045
Phone:
+ 61 (0)3 9824 5254
Facsimile: + 61 (0)3 9822 7735
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.
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