NASH Phase II Interim Analysis Reveals Improvement in Liver Enzymes (AST and ALT) with Good Safety and Tolerability
July 10 2017 - 08:30AM
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.
The NASH Phase 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.
The demographics 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).
Highlights from the interim analysis are as
follows:
- IMM-124E was safe and there were no safety signals when
compared to placebo.
- The treatment was well tolerated and no subjects discontinued
therapy due to side effects.
- The IMM-124E 1200mg and 600mg groups, as well as the
placebo group, all demonstrated a significant change of ALT at 24
weeks compared to baseline (p=0.0038, p=0.016 and p=0.0337).
However, no statistical difference was noted between the
groups.
- When accounting for all ALT values thoughout the study period,
the area under the curve (AUC) was calculated, and when correcting
for ALT baseline values (using ANCOVA), a trend (p=0.067) in
improvement in ALT was noted in the 1200 mg group when compared to
placebo .
- When using the predicted ALT-AUC values, the overall AUC for
ALT was statistically significantly lower for the 1200mg and 600mg
groups (p=0.0036 and p=0.0075, respectively) when compared to
placebo.
- The overall AUC for AST values, when corrected for baseline
values, was also significantly lower in the 1200mg and 600mg dose
groups (p=0.0036 and p=0.0098, respectively) when compared to
placebo.
- There was no evidence of systemic absorption of IMM-124E as
assessed by circulating bovine immunoglobulin.
- At the time of this interim analysis, no difference was noted
in the hepatic fat fraction (HFF), which is the study’s
primary endpoint between the groups. This is most likely
attributable to the small sample size in this analysis.
Based on the 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.
Dan Peres, Immuron’s Head of Medical
commented:
"We are encouraged as both ALT and AST
demonstrated strong correlation, suggesting an improvement of liver
injury in the IMM-124E treated patients.
We 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.”
Immuron CEO Thomas Liquard, added:
“We 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.”
ABOUT IMMURON:
Immuron 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.
For more information visit:
http://www.immuron.com
FORWARD-LOOKING STATEMENTS:
This press release may contain “forward-looking
statements” within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934,
each as amended. Such statements include, but are not limited
to, any statements relating to our growth strategy and product
development programs and any other statements that are not
historical facts. Forward-looking statements are based on
management’s current expectations and are subject to risks and
uncertainties that could negatively affect our business, operating
results, financial condition and stock value. Factors that could
cause actual results to differ materially from those currently
anticipated include: risks relating to our growth strategy; our
ability to obtain, perform under and maintain financing and
strategic agreements and relationships; risks relating to the
results of research and development activities; risks relating to
the timing of starting and completing clinical trials;
uncertainties relating to preclinical and clinical testing; our
dependence on third-party suppliers; our ability to attract,
integrate and retain key personnel; the early stage of products
under development; our need for substantial additional funds;
government regulation; patent and intellectual property matters;
competition; as well as other risks described in our SEC filings.
We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any
changes in events, conditions or circumstances on which any such
statement is based, except as required by law.
COMPANY CONTACT:
Thomas Liquard
Chief Executive Officer
AUS Ph: +61 (0)3 9824 5254
thomasliquard@immuron.com
AUSTRALIA INVESTORS RELATIONS:
Peter Taylor
NWR Communications
AUS ph: Ph: +61 (0)4 1203 6231
peter@nwrcommunications.com.au
US INVESTORS RELATIONS:
Jon Cunningham
RedChip Companies, Inc.
US Ph: +1 (407) 644 4256, (ext. 107)
jon@redchip.com
US PUBLIC RELATIONS:
Eric Fischgrund
FischTank - Marketing and PR
US Ph: +1 (646) 699 1148
eric@fischtankpr.com
Immuron (NASDAQ:IMRN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Immuron (NASDAQ:IMRN)
Historical Stock Chart
From Mar 2023 to Mar 2024