Initiation of Phase IIb trial
Immupharma PLC
06 December 2007
For Immediate Release 6 December 2007
ImmuPharma PLC
Initiation of Phase IIb trials for IPP - 201101 in patients with Lupus;
Allows earlier release of efficacy data in mid 2008
ImmuPharma PLC (LSE:IMM), ('ImmuPharma' or the 'Company'), the specialist drug
discovery and development company, announces today that following its
discussions with the US Food and Drug Administration ('FDA'), it has obtained
feedback that refines the phase II/III programme for IPP- 201101 in patients
with Systemic Lupus Erythematosus. The outcome of this consultation with the
regulator has been the segmenting of the development programme into separate
phase IIb and phase III trials. The company had previously expected a single
phase II/III trial in 240 patients over 12 months. The revised plans allow the
company to have additional phase II data, which has the potential to enhance its
commercial attractiveness, earlier than previously expected and continuing with
a simpler phase III trial in Q3 2008, broadly in line with previous development
timelines. ImmuPharma expects the first patients to be dosed into the phase IIb
trials very shortly.
As part of an Initial Investigational New Drug application, the company filed in
July 2007 with the FDA a protocol for a phase II/III double blind, randomised,
placebo controlled, multicentre study in 240 patients to be treated for 12
months. Following its meeting with the FDA, ImmuPharma is now planning to
conduct a phase IIb study in 200 patients in Europe and Latin America. This
phase IIb study, which has just started, is a robust, randomised,
placebo-controlled, three-arm dose ranging study in patients treated for three
months with an additional three month follow-up. It is expected that the
patients from this phase IIb trial will be rolled into a one-year 'open label'
safety and efficacy study which should report by Q3 2009. In addition, in Q3
2008 a similar but pivotal phase III study will be commenced in an additional
200 patients in the US, Europe and Latin America, to be treated for a period of
six months. The phase III study is expected to report by Q3 2009. In parallel
with the phase IIb trial, the company will also complete a long-term
pre-clinical toxicology study as part of regulatory requirements.
Dr Robert Zimmer, MD, PhD, ImmuPharma's Chief Scientific Officer commented:
'As IPP-201101 has already completed a successful phase II study last year, this
second and larger study will yield valuable additional efficacy and safety data
in the summer of 2008. A submission for approval is currently anticipated in
late 2009. This phase IIb study will be funded from the Company's existing cash
resources.
Dimitri Dimitriou, ImmuPharma's CEO added:
'Essentially, we are dividing the phase II/III programme in two parts which
reduces the risk for ImmuPharma and provides data much earlier than previously
planned. This will provide patients with a much needed drug where there are no
specific drugs available today. From a commercial perspective, the refined phase
II/III programme has the potential to enhance the commercial attractiveness of
our most advanced drug candidate earlier than anticipated once the data from our
phase IIb are available.'
For further information please contact:
ImmuPharma PLC:
Dimitri Dimitriou, Chief Executive Officer +44 20 7152 4080
Dr Robert Zimmer, President & Chief + 33 389 32 76 50
Scientific Officer
Richard Warr, Chairman +44 20 7152 4080
Buchanan Communications + 44 20 7466 5000
Lisa Baderoon
Rebecca Skye Dietrich
Panmure Gordon & Co
Andrew Burnett +44 151 243 0963
For company information, visit www.immupharma.com
Notes to Editors:
About ImmuPharma
ImmuPharma PLC is a drug discovery and development company headquartered in
London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has
research operations in France (ImmuPharma (France) SA) and Switzerland
(ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs,
largely based on peptide therapeutics, to treat serious medical conditions such
as autoimmune diseases characterised by:
* blockbuster potential in niche markets
* low promotional costs in few specialised physicians and centres and
* lower risk of drug development and lower development costs
ImmuPharma is a currently developing drug candidates for three different medical
conditions, each of which would represent a significant breakthrough in its
field. The furthest advanced drug candidate targets Lupus, a disease for which
there is currently no cure or specific treatment. The other two address moderate
to severe pain (such as that experienced by cancer sufferers and post-operative
patients), and MRSA and similar severe hospital-acquired resistant infections.
All three have significant sales potential as well as low marketing costs and a
relatively low risk of development failure. One or more have the potential to be
fast-tracked by the US Food and Drug Administration according to 'Guidance for
Industry: Fast Track Drug Development Programs - Designation, Development and
Application Review' issued July 2004 and could therefore obtain their market
authorization by 2010.
Key to the potential success of ImmuPharma is its unique collaborative agreement
with Centre National de la Recherche Scientifique, France's scientific research
institution. This agreement grants ImmuPharma worldwide exclusive rights to
exploit certain key discoveries.
In addition to its three leading drug candidates, ImmuPharma has a drug
development pipeline using its rights to a virtual chemical library of hundreds
of thousands of molecules as well as an innovative technology for converting
peptides to drug candidates.
ImmuPharma has the option to commercialise its assets itself or to license them
to other pharmaceutical companies at an earlier stage.
The products
Treatment of Lupus (IPP-201101)
This is a long-term treatment for Lupus, a chronic, life-threatening autoimmune
disease where the immune system attacks healthy cells. There is currently no
cure and existing medications only treat the symptoms whereas ImmuPharma's drug
candidate has the potential to produce remission of the disease in a substantial
proportion of patients.
Based on independent forecasts, the value of ImmuPharma's Lupus drug is
estimated to be 'substantial' with peak annual sales forecast to generate in
excess of $4 billion.
Severe pain relief (IPP-102199)
ImmuPharma is developing a potential non-addictive compound for relieving
moderate to severe pain, such as experienced by cancer sufferers and
post-surgical patients. Most existing treatments are derived from the opiate
morphine and tend to have serious side effects. ImmuPharma's new treatment is
based on met-enkephalin, the body's internal analgesic. IPP-102199 is being
developed to have major advantages over morphine such as longer pain relief
duration and reduced side effects. The market for chronic opioids in the US
currently exceeds $3.5 billion and is growing by more than 10 to 20 per cent a
year.
Antibiotic for MRSA and similar highly resistant infections (IPP-203101)
This is a novel antibiotic to combat MRSA and other severe hospital-acquired,
resistant infections which affect some two million people in the US, according
to the US Centers for Disease Control and Prevention. ImmuPharma's drug
candidate is targeted at disrupting the membrane potential of the bacterial
pathogens. It is hoped this novel approach will reduce their potential to become
resistant.
PLA2 inhibitor for inflammatory and allergic disorders (IPP-201007)
Phospholipases A2 (PLA2s) are enzymes that catalyze the hydrolysis of
phospholipids. This catalytic reaction is essential in the production of lipids
during various processes in the body, involving prostaglandins, leukotrienes,
thromboxanes, platelet activation factor and others. In certain cases, such
lipids mediators cause allergic reactions and a number of inflammatory
conditions such as asthma and other respiratory disorders, rheumatoid arthritis,
septic shock and acute pancreatitis are characterized by a significant increase
in PLA2 activity.
Inhibiting PLA2 can therefore reduce some of these allergic reactions and
inhibitors of PLA2 have already been shown to have positive effect in
inflammatory conditions. ImmuPharma believes this new molecule has potential in
becoming a drug for certain inflammatory conditions and intends to progress its
development. The drug could be in clinical trials as early as 2009.
This information is provided by RNS
The company news service from the London Stock Exchange