MELBOURNE, Australia, June 23, 2016 (GLOBE NEWSWIRE) -- Australian microbiome biopharmaceutical company Immuron Limited (ASX:IMC) (OTCQB:IMROY) today announced that the Company’s IMM-124E Phase II clinical trial for the treatment of NASH (Non-Alcoholic Steatohepatitis) has successfully reached its 50% recruitment milestone with 56 patients having been successfully randomised and an additional 4 patients to be randomised this week. To date, 25 patients have successfully completed treatment.
The Company is also pleased to announce that no significant treatment adverse events have been reported.
Patients who qualify for the clinical trial are randomised into 3 groups who receive either; a 600 mg or 1,200 mg dose of IMM-124E, or Placebo, three times daily. The Company expects recruitment to be finalised during the second half of 2016.
Immuron now has a total of 28 active clinical study sites across the USA, Australia and Israel, including 4 additional sites initiated since January. The Company has also targeted 2 additional sites in the US which is on track to commence enrolment in June 2016.
Commented Dan Peres, Immuron’s Head of Medical:
“This is a significant milestone for the company, and a great achievement by the team. We continue to work with our study sites to find ways to accelerate recruitment. IMM-124E has several advantages over our competitors including a great safety profile which provides a compelling option for our PIs and their patients.”
In December 2014, the Company announced the launch of the NASH Phase II multinational multicenter randomised double blind placebo controlled study of its proprietary compound IMM-124E for the treatment of NASH, with the first patient randomised in February 2016. The protocol was developed by Immuron in partnership with its Scientific Advisory Board led by Prof. Arun Sanyal of Virginia Commonwealth University (USA).
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/
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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