TIDMIMM
RNS Number : 0988L
Immupharma PLC
17 April 2018
17 April 2018
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
ImmuPharma PLC
("ImmuPharma" or the "Company")
Topline results of Lupuzor(TM) Pivotal Phase III Trial
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, announces the results of its pivotal Phase III
trial of Lupuzor(TM), its lead programme for the potential
breakthrough compound for Lupus.
Key highlights:
-- Lupuzor(TM) demonstrated a superior response rate over
placebo* (52.5% vs 44.6% "responders"**) in the primary analysis on
the Full Analysis Set of all 202 patients (including withdrawals
who are considered non-responders). However, due to a high response
rate in the placebo group, this superior response did not allow
statistical significance to be reached (p = 0.2631) and the trial's
primary end point was not met.
-- Lupuzor(TM) also demonstrated a superior response rate over
placebo (68.8% vs 59.2%) in the 153 patients who completed the
study (p value not currently available).
-- Importantly, in patients who had anti-dsDNA autoantibodies (a
recognised biomarker for Systemic Lupus Erythematosus ('SLE')),
Lupuzor(TM) demonstrated a superior response rate over placebo
(61.5% vs 47.3%, p = 0.0967). In addition, 7.6% of these patients
in the Lupuzor(TM) group went into full remission versus none in
the placebo group.
-- The study confirmed the outstanding safety profile of
Lupuzor(TM), with zero serious adverse events reported.
-- The Company believes these topline results provide evidence
for the continued investigation into the development and
commercialisation of Lupuzor(TM) as it has the potential to offer
patients and physicians a much needed effective and safe treatment
for Lupus.
* Based on the protocol and the commonly accepted study design,
there were two groups of patients: (1) patients receiving
Lupuzor(TM) plus "Standard of Care" and (2) patients receiving
placebo plus "Standard of Care". "Standard of Care" includes
treatment with other drugs such as steroids, anti-malarials,
methotrexate etc. It is important to note that when reference is
made to placebo, there are no patients who were treated just with
placebo, but all were receiving other drug treatments.
** The definition of a "responder" is based on the SLE Responder
Index (SRI-4) score, which requires a reduction of at least four
points in this score. Therefore, patients who improve by less than
four points are counted as non-responders, but also no distinction
is made between patients who improve by more than 4 points, all
being equal "responders".
Separately, as previously announced, following requests from
both Investigators and patients involved in the Phase III study,
ImmuPharma has initiated an additional study permitting all
patients who participated in the Phase III study, to receive
Lupuzor(TM) (plus "Standard of Care") for six months in an
open-label scheme. The results will be gathered as an "extension"
open label study, independent of the pivotal Phase III trial. The
Company looks forward to providing further updates regarding this
study in due course.
Next Steps
The Board believes that there is a significant opportunity for
an efficacious and safe treatment for lupus patients given the
treatment alternatives currently available, and that there is a
desire from both physicians and patients for such a treatment, as
evidenced by the investigator and patient-led extension study
described above. The Company will undertake a review of the pivotal
study's full dataset and will work with its regulatory advisers to
determine the optimal next steps.
Following expressions of interest in the Lupuzor(TM) programme
and the Phase III study, ImmuPharma is in ongoing discussions with
a number of larger pharmaceutical companies. The results of this
study will now be shared with those potential commercial partners.
There can be no certainty as to the outcome or timing of these
discussions.
The Company will provide further updates on its
clinical/regulatory and commercial strategy for Lupuzor(TM) as
appropriate going forward.
Commenting on the results, Dr Robert Zimmer MD, PhD, Chief
Scientific Officer said: "The study demonstrated that Lupuzor(TM)
had a superior response rate over placebo and has an outstanding
safety profile. The results in the anti-dsDNA antibody positive
group are also encouraging. As we receive further data, we will
analyse them and work with our regulatory advisers to agree the
optimum way forward."
Professor Sylviane Muller PhD, Research Director at the CNRS
commented "The results of the study show the potential benefits
that can be delivered to patients taking Lupuzor(TM). In addition,
we believe these results have added further evidence to
pre-clinical data we have generated to support the development of
Lupuzor(TM) in a number of other auto-immune diseases."
Tim McCarthy, Chairman added: "Lupuzor(TM) has demonstrated, in
this study, a superior response rate over placebo and its
exceptional safety, giving it, we believe, a compelling product
profile. Whilst we are disappointed at the high response in the
placebo plus Standard of Care group that resulted in statistical
significance not being reached between the two treatment groups, we
believe Lupuzor(TM) has the potential to bring a much needed safe
treatment to the millions of Lupus sufferers around the world. We
look forward to providing our shareholders with further updates in
due course."
Dimitri Dimitriou, Chief Executive Officer added: "It is an
achievement for a small biotech company to complete a phase III
trial. We will now be actively following up with all the
pharmaceutical companies that have expressed interest in
Lupuzor(TM) and its commercial potential."
For more information on the trial please visit:
https://clinicaltrials.gov/ct2/show/NCT02504645
-Ends-
For further information please contact:
+ 44 (0) 20 7152
ImmuPharma plc 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor Relations
Twitter: @immupharma + 44 (0) 7721 413496
Northland Capital Partners Limited
David Hignell, Dugald Carlean, Jamie Spotswood,
Corporate Finance
Rob Rees, Corporate Broking +44 (0)203 861 6625
Bryan Garnier & Co. Limited
Phil Walker, Corporate Finance
Dominic Wilson, Corporate Broking +44 (0)207 332 2500
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) has been 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 and efficacy 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 auto-immune and
even 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. It has been recently demonstrated (published in
Cancer Res) that the Nucants improve the vascularisation of
tumours, increasing thereby the cytotoxic drug concentration and
consequently the reduction of tumour size. In connection with the
increased vascularization we investigated its use in age-related
macular degeneration where it has demonstrated positive preclinical
efficacy results, diabetic retinopathy and other ophthalmological
indications. Two phase I trials have been completed and IPP-204106
is Phase II ready.
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 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) and in Non-Alcoholic Steato-Hepatitis
(NASH) where outstanding results have been obtained in validated
pre-clinical experiments with peptide URK 614. There is also
potential in cancer treatment (protein/protein interaction; P53
gene).
This information is provided by RNS
The company news service from the London Stock Exchange
END
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