Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

Immuron Ltd Regulatory Filings 2016

Oct 9, 2016

35121_rns_2016-10-09_decaa6aa-b3e7-4e6f-a597-d6e16997c8d9.pdf

Regulatory Filings

Open in viewer

Opens in your device viewer

`

==> picture [220 x 62] intentionally omitted <==

NASH Phase II Trial Reaches 90 (75%) Patient Recruitment Milestone

Melbourne, Australia, Monday 10[th] October 2016: Australian biopharmaceutical Company Immuron Limited (ASX: IMC) is pleased to announce that the Company’s IMM-124E Phase II clinical trial for the treatment of NASH (Non-Alcoholic Steatohepatitis) has successfully reached its 75% recruitment milestone with 90 patients having been successfully randomised. The Company is looking to randomise a total of 120 patients for the trial.

The Company is also pleased to announce there have been no serious adverse events related to the study drug.

The Company is still targeting end of the calendar year 2016 to finalise the randomisation of all 120 patients throughout its 28 active IMM-124E clinical sites across the USA, Australia and Israel.

Immuron’s Senior VP Head of Medical Dr Dan Peres commented:

“This significant milestone is the result of our efforts to significantly accelerate our recruitment rate including amending our clinical trial protocol which has allowed our sites to recruit more efficiently.

12 patients were randomised in August 2016 alone, our best recruitment month since the start of the trial, and we have a very healthy screening pipeline with more than 20 patients in screening at our various sites around the world.

These recruitment results continue to highlight the strong demand for Immuron’s IMM-124E with our Principal Investigators (PIs) as well as with their patients, and we look forward to continue working closely with our sites to close out the randomisation process as soon as practicable.”

In December 2014, the Company announced the launch of its NASH Phase II multinational multicenter randomised double-blind placebo controlled study of its proprietary compound IMM-124E for the treatment of NASH. The trial’s first patient was randomised in February 2016.

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).

    • END - -

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

==> picture [71 x 23] intentionally omitted <==

Company Contact: Immuron Media Relations: Thomas Liquard John Beveridge Chief Executive Officer Monsoon Communications Ph: +61 (0)3 9824 5254 Ph: +61 (0)3 9620 3333 [email protected] [email protected]

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/

Page 2 of 3

==> picture [71 x 23] intentionally omitted <==

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.

Page 3 of 3