TIDMIMM
RNS Number : 4395P
Immupharma PLC
29 May 2018
FOR IMMEDIATE RELEASE 29 May 2018
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
ImmuPharma PLC
("ImmuPharma" or the "Company")
Further Analysis from its Pivotal Phase III Trial of Lupuzor(TM)
in Patients with
Systemic Lupus Erythematosus (SLE) Shows Positive Results in the
Europe Cohort(1)
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to announce further analysis of the
results from its pivotal Phase III trial of Lupuzor(TM), its lead
programme for the potential breakthrough compound for Lupus, a
potentially life threatening auto-immune disease.
This new data follows the top-line trial results published on 17
April 2018 and which may create new commercial value for
Lupuzor(TM). As previously announced, across the whole study
population, in those patients who had anti-dsDNA autoantibodies,
Lupuzor(TM) demonstrated a superior response rate over placebo
(61.5% vs 47.3%, p=0.0967), although these results were not
statistically significant.
Highlights of new data analysis
-- Further data analysis demonstrated that in the Europe
cohort(1) (130 patients) Lupuzor(TM) plus standard of care ("Active
Group") showed statistically significant reductions (71.1% vs
48.8%, p=0.0218) in disease activity compared to placebo plus
standard of care ("Comparator Group") in 79 patients (60.8%) who
were anti-dsDNA autoantibody positive ("Antibody Positive").
-- In the US cohort (72 patients) there were 28 patients who
were Antibody Positive (40%) with an equal number of 14 patients in
both the Active and Comparator Groups. Of these, 5 patients were
responders in the Active Group with 6 responders in the Comparator
Group (35.7% vs 42.8%). This contrasting result in the US compared
to the positive result in the Europe cohort, may be due to a number
of differing factors between the two cohorts, which requires
further investigation.
-- Scientific literature indicates that approximately 60-70% of
patients diagnosed for Lupus are Antibody Positive(2) . These
proportions were seen in the Europe cohort (60.8% of patients were
Antibody Positive) and could therefore be considered as
representative of the overall Lupus population.
-- In those patients who were anti-dsDNA autoantibody negative
("dsDNA negative") there was almost no difference in disease
activity reduction between the Active Group and Comparator
Group.
-- Anti-dsDNA autoantibodies are a recognised biomarker for Systemic Lupus Erythematosus.
-- This finding indicates that the activity of Lupuzor(TM) could
be correlated with the presence of anti-dsDNA autoantibodies in
Lupus patients. ImmuPharma believes that predictive biomarkers,
such as anti-dsDNA autoantibodies, could allow identification of
patients that are more likely to respond positively to treatment
with Lupuzor(TM).
-- The results can be summarised as follows:
Full Set Active Group Comparator
Group
-------------------- ------------- -----------
N 101 101
-------------------- ------------- -----------
Anti-dsDNA
antibody positive
(N=107, 53%) 52 (51.5%) 55 (54.4%)
-------------------- ------------- -----------
Responders
in anti-dsDNA
antibody positive
patients 32 (61.5%) 26 (47.3%)
-------------------- ------------- -----------
Europe Cohort Active Group Comparator
Group
-------------------- ------------- -----------
N 65 65
-------------------- ------------- -----------
Anti-dsDNA
antibody positive
(N=79, 60.8%) 38 (58.5%) 41 (63%)
-------------------- ------------- -----------
Responders
in anti-dsDNA
antibody positive
patients 27 (71.1%) 20 (48.8%)
-------------------- ------------- -----------
US Cohort Active Group Comparator
Group
-------------------- ------------- -----------
N 36 36
-------------------- ------------- -----------
Anti-dsDNA
antibody positive
(N=28, 38.9%) 14 (38.9%) 14 (38.9%)
-------------------- ------------- -----------
Responders
in anti-dsDNA
antibody positive
patients 5 (35.7%) 6 (42.8%)
-------------------- ------------- -----------
(1) The phase III trial had two regional cohorts per
protocol:
1) Europe cohort (Czech Republic, France, Germany, Hungary,
Poland & Mauritius)
2) US cohort
Each cohort had patients randomised 1:1 between the Active Group
and the Comparator Group.
(2) Isenberg DA, et al. Ann Rheum Dis 2016; 75:323-331. Mosca M,
et al. J Rheumatol 2006; 33(4): 695-697. Gheita TA, et al. Lupus
2018; 27(7):1081-1087.
Next steps
Immupharma will continue to review the Lupuzor(TM) Phase III
pivotal study's full dataset and will provide further updates as
information becomes available and as publications are submitted in
medical journals and scientific congresses.
ImmuPharma will discuss these findings with its regulatory,
scientific and medical experts in order to formulate discussions
with the regulatory agencies on next steps. In parallel, the
Company will also continue to progress discussions with potential
corporate partners. At present there can be no guarantee that these
discussions will result in a positive outcome for the Company but
further announcements will be made as appropriate.
Extension study
The Lupuzor(TM) extension study, which was announced on 18
January 2018, is continuing and at present 44 patients have been
recruited. The study is anticipated to conclude recruitment around
the end of June 2018 and report results in 2019. We believe that
this will provide more valuable information on the potential
efficacy and safety of Lupuzor(TM).
Commenting on the results, Dr Robert Zimmer MD, PhD, Chief
Scientific Officer said: "We believe these additional results in
Antibody Positive patients are of great value.
The data showed that Antibody Positive patients in the Europe
cohort responded significantly better when receiving Lupuzor(TM),
compared to those in the Comparator Group.
Current treatments (monoclonal antibodies, steroids etc.,)
prescribed to Lupus patients are essentially symptomatic treatments
acting irrespectively of the antibody status of the patients. The
potential efficacy of Lupuzor(TM) seems to be correlated with the
presence of anti-dsDNA auto-antibodies, a biomarker for Lupus, and
we hope to confirm that Lupuzor(TM) will come to be considered as a
disease modifying agent.
We believe this is in line with what healthcare practitioners
are seeking: precision medicines to target therapies, using
biomarkers that reference precisely those patients who could
benefit from the treatment options available. This should reduce
healthcare costs and improve patient outcomes."
Tim McCarthy, Chairman added: "In this study Lupuzor(TM) has
demonstrated a superior response rate over placebo and confirmed
its exceptional safety profile. We believe this gives Lupuzor(TM) a
compelling product profile. We are highly encouraged by the
statistical significance achieved in the Antibody Positive patient
group in the Europe cohort. We continue to believe Lupuzor(TM) has
the potential to bring a much needed treatment to Lupus sufferers
around the world. We look forward to providing our shareholders
with further updates as we move forward with this programme."
For further information please contact:
+ 44 (0)
20 7152
ImmuPharma plc (www.immupharma.co.uk) 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor Relations + 44 (0)
Twitter: @immupharma 7721 413496
Northland Capital Partners Limited
(NOMAD & Joint Broker)
David Hignell, Dugald Carlean, Jamie
Spotswood, Corporate Finance +44 (0)20
Rob Rees, Corporate Broking 3861 6625
Bryan, Garnier & Co. (Joint Broker)
Phil Walker, Corporate Finance +44 (0)20
Dominic Wilson, Sales 7332 2500
-Ends-
Notes to Editors
ImmuPharma PLC
ImmuPharma is a pharmaceutical development company listed since
2006 on AIM of the London Stock Exchange (AIM: IMM), focusing on
developing novel medicines with high sales potential in specialist
markets with serious unmet need. ImmuPharma is led by a
commercially focused Board and management team with extensive
experience.
Lupuzor(TM)
Lupuzor(TM) (also referred to as Forigerimod, or P140) is
ImmuPharma's lead compound and a potential treatment for lupus (or
Systemic Lupus Erythematosus), a chronic, potentially
life-threatening auto-immune disease. Lupuzor(TM) has a novel
mechanism of action aimed at modulating the body's immune system so
that it does not attack healthy cells, and avoids causing adverse
side effects. It has the potential to halt the progression of the
disease in a substantial proportion of patients.
Lupuzor(TM) was granted Fast Track status by the US FDA and
approval to start Phase III under Special Protocol Assessment (SPA)
comprising of two phase III trials. This SPA was subsequently
amended due to its strong safety profile to allow for a reduced
number of patients in the pivotal Phase III trial thereby reducing
the projected cost and time of development considerably.
The recently completed pivotal Phase III clinical trial was
entitled "A 52-Week, Randomized, Double-Blind, Parallel-Group,
Placebo-Controlled Study to Evaluate the Efficacy and Safety of a
200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With
Systemic Lupus Erythematosus".
Commercial Opportunity
There are an estimated five million people globally suffering
from Lupus, with approximately 1.5 million patients in the US,
Europe and Japan (Source: Lupus Foundation of America). Current
'standard of care' treatments, including steroids and
immunosuppressants, can potentially have either serious side
effects for patients or limited effectiveness, with over 60% of
patients not adequately treated. If Lupuzor(TM) is approved, it
will be entering a market with the potential for multi-billion
dollar sales.
P140/Forigerimod in other indications
ImmuPharma together with Professor Sylviane Muller, Lupuzor's
inventor, have presented new evidence supporting Lupuzor's(TM)
Forigerimod / P140 peptide activity in several other major
auto-immune disease indications outside of Lupus. In particular,
the peptide appears to have general effects against chronic
inflammatory indications and pre-clinical evidence supports the
molecule's use in: Neuropsychiatric lupus (NPSLE); Gougerot-Sjögren
Syndrome (GSS); Guillain-Barré Syndrome; Chronic Inflammatory
Demyelinating Polyneuropathy; Arthritis; Crohn's Disease and
Asthma.
Oncology and Ophthalmology
ImmuPharma's second most advanced pipeline programme,
IPP-204106, is a potential treatment for various cancers and acts
by modulating angiogenesis and proliferation. The programme
involves the development of synthetic peptides, Nucants, which
target certain nuclear proteins such as nucleolin and nucleophosmin
on the surface of cells, with very high affinity and selectivity.
Nucleolin is a protein which controls critical pathways within the
cell. The protein is over-expressed at the surface of dividing
cells which makes its binding with Nucants very attractive because
of its potential selectivity - this is of particular importance in
tumour targeting. We are also investigating its use in age-related
macular degeneration where it has demonstrated positive preclinical
efficacy results, diabetic retinopathy and other ophthalmological
indications.
Metabolism and Diabetes
ImmuPharma's subsidiary 'Ureka' has initiated the development of
a novel and innovative peptide technology platform through the
collaboration with CNRS, gaining access to pioneering research
centred on novel peptide drugs at the University of Bordeaux and
the Institut Européen de Chimie et Biologie (IECB). Jointly,
ImmuPharma and CNRS have filed a new co-owned patent controlling
this breakthrough peptide technology. Ureka's current focus is in
Diabetes Type II (GLP-1 analogues - once a month administration);
Non-Alcoholic Steato-Hepatitis (NASH) and there is also potential
in cancer treatment (protein/protein interaction; P53 gene).
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END
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