MELBOURNE, Australia, Nov. 18, 2015 (GLOBE NEWSWIRE) -- Australian biopharmaceutical Company Immuron Limited (ASX:IMC) (OTCQB:IMROY) is pleased to announce that the Company’s Phase IIb, the IMM-124E clinical trial for the treatment of NASH (Non-Alcoholic Steatohepatitis), has successfully passed its 25% recruitment milestone with 35 patients having been successfully randomized into either arms.
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 biopsy-proven NASH subjects by June 2016. Patients who qualify for the clinical trial are randomized into three groups of patients who receive either a 600 mg or 1200 mg dose of IMM-124E, or Placebo, three times daily.
Immuron now has a total of 22 active clinical study sites across the USA, Australia and Israel, including three additional sites initiated in the past three months. The Company has also targeted three 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 randomized double blind placebo controlled study of its proprietary compound IMM-124E for the treatment of NASH, with the first patient randomized in February 2015. 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.
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/
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.