Immuron Successfully Completes NASH Phase II Clinical Study Milestone
November 09 2017 - 9:00AM
Immuron Limited (ASX:IMC) (NASDAQ:IMRN), an Australian microbiome
biopharmaceutical company focused on developing and commercialising
oral immunotherapeutics for the treatment of gut-mediated diseases,
announced today that it has completed its Last Patient Last Visit
(LPLV) for its IMM-124E Phase II study for the treatment of NASH,
and expects data due in the first quarter of next year (Q1 CY2018).
The last patient in the Company's NASH clinical
study conducted the final scheduled visit on October 9, following a
28-week study period. The study enrolled a total of 133 patients
with biopsy-proven NASH. On October 18, the same study site
conducted its Close-Out Visit (COV), the last on-site monitoring
visit conducted for the study. This effectively concludes patient
dosing and research activities at all study sites for the IMM-124E
Phase II study.
Immuron will report its top line clinical trial
results in the Q1 CY2018, once all data is finalised and reviewed
by the Company and its Scientific Advisory Board. Once reported,
the Company will continue its partnering and business development
efforts to reach the next phase of clinical studies.
In July 2017, the Company announced its interim
analysis results conducted by analysing a total of 122 patients, 80
of which completed their 24-week treatment of IMM-124E. In this
report, IMM-124E demonstrated good safety features compared to the
placebo. Additionally, the Data and Safety Monitoring Board (DSMB)
reported that IMM-124 demonstrated a statistically-significant
reduction in ALT – an enzyme most commonly found in the liver –
over time when the two treatment doses were compared to the placebo
arm. The same effect was noted for AST – another enzyme found in
the liver – and a correlation between these two enzymes was also
reported. These preliminary results suggest a reduction in liver
injury (necro-inflammation) over the duration of treatment compared
to the placebo.
"We are now working diligently to analyse and
collate all remaining data from our contracted laboratories and
CROs,” said Immuron Head of Medical, Dr. Dan Peres.
“Following thorough analysis, we expect to
report our top line results in Q1 CY2018. Based on the safety
profile and the efficacy signal we reported earlier this year, we
believe that the results generated by this analysis position
IMM-124E as a unique product for treating NASH patients on its own,
or in combination with other promising treatments.”
“The completion of these patient studies marks a
pivotal inflection point for Immuron, as we now look forward to
analysing and reporting the data results,” said Jerry Kanellos, CEO
of Immuron Ltd.
“The pharmaceutical quest to treat NASH that
many call the ‘Dash to NASH’ is one that represents tremendous
market opportunity and high-growth potential. We hope to continue
advancing through later stages of clinical trials, and ultimately
making a difference for NASH patients and the medical community, as
well as realizing value for shareholders.”
* Data Safety and Monitoring
Board** Alanine transaminase – measured levels of ALT assist
in liver function evaluation
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COMPANY
CONTACT: |
AUS INVESTOR RELATIONS: |
|
|
Jerry
Kanellos |
Peter
Taylor |
Chief Executive
Officer |
NWR Communications |
Ph: +61 (0)3 9824
5254 |
Ph: +61 (0)4 1203
6231 |
jerrykanellos@immuron.com |
peter@nwrcommunications.com.au |
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USA MEDIA
CONTACT: |
USA INVESTOR RELATIONS: |
|
|
Kate
Caruso-Sharpe |
Jon
Cunningham |
FischTank Marketing and
PR |
RedChip Companies,
Inc. |
US Ph: + 1 646 699
1414 |
US Ph: +1 (407) 644
4256, (ext. 107) |
kate@fischtankpr.com |
jon@redchip.com |
ABOUT IMMURON:Immuron Ltd
(ASX:IMC) is a biopharmaceutical company focused on developing and
commercialising oral immunotherapeutics for the treatment of 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’ diarrhea whilst its lead product
candidate IMM-124E is in Phase 2 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
About the IMM-124E StudyThe
IMM-124E study is a Phase 2 proof of concept multinational,
randomized, double-blind study comparing 2 doses IMM-124E to
placebo for the treatment of NASH in adults with any stage
biopsy-proven NASH. The trial enrolled 133 patients and is still on
going. The primary endpoint is the improvement of liver steatosis
as assessed by MRI comparing the mean values), as measured at the
24 weeks' time point. The key secondary endpoints are: change in
ALT as well as other liver enzymes and metabolic markers.
IMM-124E enrolled adults with all-stage biopsy
proven NASH up to 12 months of randomization.
About IMM-124EIMM-124E is an
oral, three-times-daily, non-absorbable compound containing
poly-clonal anti-LPS immunoglobulins proposed to interact with the
gut LPS and immune system to achieve an immunomodulatory effect
reducing LPS-related inflammation and inducing tolerance. Because
of this unique mechanism of action, targeting multiple pathways,
IMM-124E has the potential to play a differentiated role in the
management of NASH and may form the cornerstone of NASH combination
treatment strategies, both as a single agent and in combination
with other agents.
In addition to the adult NASH study, IMM-124E is
also being evaluated in the pediatric population in a Phase 2
proof-of-concept study of IMM-124E in children with Pediatric
NAFLD.
About Non-Alcoholic Steatohepatitis
(NASH)NASH is a severe type of non-alcoholic fatty liver
disease (NAFLD), which is characterized by the accumulation of fat
in the liver with no other apparent causes. NASH occurs when the
accumulation of liver fat is accompanied by inflammation and
cellular damage. The inflammation can lead to fibrosis (scarring)
of the liver and eventually progress to cirrhosis, portal
hypertension, liver cancer, and eventual liver failure.
NASH is an emerging health crisis impacting 3%
to 5% of the U.S. population and 2% to 4% globally, and is the
fastest growing cause of liver cancer and liver transplant in the
U.S. The increasing prevalence of NASH is attributed to the growing
obesity epidemic and the disease is often diagnosed in patients who
have diabetes, high cholesterol or high triglycerides. There is
currently no approved treatment for NASH.
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
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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
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