Full Press Release Details
II Interim Analysis Reveals Improvement in Liver Enzymes (AST and ALT) with Good Safety and Tolerability
Trial to Continue to Completion
Australia, 10 July 2017: Australian biopharmaceutical company, Immuron Limited (ASX: IMC; NASDAQ: IMRN), is pleased to announce
safety and efficacy results of the interim analysis of its ongoing IMM-124E Phase II study in NASH. The objectives of this analysis
was to establish the safety of the compound and to provide a preliminary read on efficacy signals.
II trial has enrolled 133 patients with the top-line results expected in 4Q2017. The pre-planned analysis was triggered when 80
subjects completed treatment.
of the population analyzed in the interim analysis were balanced in all three groups (placebo, low dose -600mg- and high dose
-1200mg-) including sex, race, age, height, weight, BMIs, HbA1c and baseline hepatic fat fraction (HFF).
from the interim analysis are as follows:
results of the interim analysis, IMM-124E has demonstrated to be a non-absorbable, safe and tolerable compound in patients with
NASH. Early biochemical improvements in liver enzymes are noted, suggesting potential therapeutic benefit for treatment of NASH.
The DSMB recommendation was to continue the trial to completion, as there is no concern for safety or futility .
Immuron's Head of Medical commented:
are encouraged as both ALT and AST demonstrated strong correlation, suggesting an improvement of liver injury in the IMM-124E
are looking forward to completing the IMM-124E study and reporting the final results with the entire body of data by the end of
the year. We believe the additional MOA data we are generating in partnership with Duke University and SanyalBio will further
strengthen our prior data to support IMM-124E's unique mechanism of action which will assist us to design of the next phase
in our clinical program."
Thomas Liquard, added:
are encouraged by the results of this interim-analysis and are pleased by the DSMB's recommendation to continue the study
to completion. NASH is increasingly viewed as a multifactorial disease whereby the approval of several chronic therapies, with
different MOAs and used in combination, will be needed to control its long-term effects. These results support our belief that
IMM-124E is a compound with a complex MOA that has the potential to have a beneficial impact in hard-to-treat fatty-liver diseases
including NASH, ASH and Pediatric NAFLD."
| COMPANY CONTACT: | US INVESTORS RELATIONS: |
| Thomas Liquard | Jon Cunningham |
| Chief Executive Officer | RedChip Companies, Inc. |
| AUS Ph: +61 (0)3 9824 5254 | US Ph: +1 (407) 644 4256, (ext. 107) |
| thomasliquard@immuron.com | jon@redchip.com |
| AUSTRALIA INVESTORS RELATIONS: | US PUBLIC RELATIONS: |
| Peter Taylor | Eric Fischgrund |
| NWR Communications | FischTank - Marketing and PR |
| AUS ph: Ph: +61 (0)4 1203 6231 | US Ph: +1 (646) 699 1148 |
| peter@nwrcommunications.com.au | eric@fischtankpr.com |
Limited (NASDAQ: IMRN; ASX: IMC), is a biopharmaceutical company focused on developing and commercialising oral immunotherapeutics
for the treatment of 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' Diarrhea and
its lead clinical candidate, IMM-124E, is in Phase 2 clinical trials for NASH, ASH and Pediatric NAFLD. Immuron's second
clinical stage asset, IMM-529, is targeting C. difficile Infections (CDI). 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 global immunotherapy market.
more information visit: http://www.immuron.com
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