Phase 1 Lupus results
Immupharma PLC
10 May 2006
FOR IMMEDIATE RELEASE 10 MAY 2006
ImmuPharma
announces successful results from its phase I clinical trial with
IPP-201101 for Lupus
- Phase II to start soon -
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,
announced today that it has successfully completed the placebo-controlled phase
I study involving 24 healthy volunteers of its lead compound IPP-201101 for
Lupus, a chronic, life-threatening autoimmune disease.
This study, which took place in France, was the first administration in humans
for IPP-201101 and was designed to assess its safety and tolerability. The
preliminary safety report confirmed that the drug was safe and well-tolerated.
These encouraging results have allowed ImmuPharma to proceed with a phase II
proof-of-concept and efficacy study in Lupus patients in Europe. The phase II
study protocol was recently approved by the ethics committees and has been filed
with the appropriate regulatory authorities. The dosing of Lupus patients in
this study is expected to start soon and the trial will measure recognised
surrogate markers of clinical efficacy, in preparation of the pivotal phase III
studies.
To that effect, ImmuPharma has also scheduled a meeting with the FDA to design
the appropriate development programme to get market authorisation of the drug in
the US.
Dr Robert Zimmer, President and Chief Scientific Officer of ImmuPharma, said:
'IPP-201101, which has blockbuster potential, is a novel concept for the
treatment of Lupus. IPP-201101 modulates the signalling of CD4+ cells and may
also interact with the T-reg pathway. The key element is that IPP-201101 has
been designed to interact only with the CD4+ cells linked to Lupus and leaves
intact the remaining immune system, allowing Lupus patients to be protected by a
fully operational immune system unlike the currently used therapies such as high
dose corticoids and immunosuppressants. When administered appropriately it has
the potential to stop the progression of the disease and should therefore be
prescribed as early as possible during the course of the Lupus disease. The
already available preclinical package demonstrating efficacy and selectivity for
Lupus together with the good results of the phase I safety and tolerability
study in man are critical in this respect and may offer clear benefit for the
patients when compared to the current therapies.'
For further information please contact:
ImmuPharma PLC:
Richard Warr, Executive Chairman: tel: +44 20 7152 4080
Dimitri Dimitriou, Chief Executive Officer: tel: +44 20 7152 4080
Dr Robert Zimmer, President & Chief Scientific Officer: tel: + 33 389 32 76 50
Buchanan Communications:
Lisa Baderoon, Director: tel: + 44 20 7466 5000
Rebecca Skye-Dietrich : tel: + 44 20 7466 5000
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 non-addictive compound for relieving moderate to
severe pain, such as experienced by cancer sufferers and post-surgical patients.
Most existing treatments are opioid-based (explain) 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 counter the effects of 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 uniquely uses an electrical charge rather than
biochemical methods against MRSA and other bacterial strains. It is hoped this
novel approach will reduce their potential to become resistant.
Key management
Richard Warr, MA, executive chairman, (age 45) has 20 years experience in
investment banking and the capital markets. He was previously a director of ABN
Amro; director and head of European sales and marketing at Credit Lyonnais;
executive director at Dresdner Kleinwort Benson Securities Ltd; and head of
European equity distribution at Swiss Bank Corporation. He has extensive
experience in corporate and governmental equity capital market transactions.
Dimitri F Dimitriou, MSc, chief executive officer, (age 45) has 20 years
experience in the pharmaceutical and biotech industry. He was senior director,
worldwide business development, at GlaxoSmithKline, where his responsibilities
included licensing deals, alliances and collaborations on a worldwide basis.
Dr Robert Zimmer, MD, PhD, chief science officer, (age 58) began his career in
1985 with Roche in Basle, where he was responsible for numerous Phase I studies.
In 1990 he joined JAGO in Basle and, on its acquisition by SkyePharma, became
director and head of research and development at SkyePharma. His expertise
includes managerial experience in multifunctional research and development and
the assessment of technologies with multi-national pharmaceutical companies.
Paddy Walker-Taylor, FCA, MCT chief financial officer, (age 59) was previously
finance director of Sir Robert McAlpine Ltd. He was involved in the AIM float of
ISG Group, in which McAlpine had a minority shareholding. Previously he had held
a number of key financial positions including finance director of Woolworths plc
and treasurer of Marks & Spencer.
Douglas Paterson, MA, FCA, senior non-executive director, (age 62) has been a
chartered accountant for 37 years and was a senior audit partner at Coopers &
Lybrand (now PricewaterhouseCoopers) for 22 years. He currently holds a number
of non-executive directorships, including Close Brothers Group plc and Goldman
Sachs International Bank.
Anthony Johnson, B Pharm (Hons), MSc, MRPharmS, non-executive director, (age 62)
has over 30 years experience in the pharmaceutical industry, focused on the
scientific aspects of deal making, support during competitive analysis,
technical due diligence and input in development strategy. He was formerly
senior director of scientific licensing at SmithKline Beecham (now
GlaxoSmithKline).
Collaboration with Centre National de la Recherche Scientifique (CNRS)
ImmuPharma has important collaboration arrangements with Centre National de la
Recherche Scientifique, France's scientific research institution, including a
research collaboration agreement relating to the therapeutic use of peptides and
peptide derivatives. ImmuPharma has been granted the worldwide exclusive rights
to exploit all discoveries made under this agreement. ImmuPharma will co-own the
relevant intellectual property with CNRS which will share in the revenue
generated by ImmuPharma from exploiting CNRS's licensed and co-owned rights.
This information is provided by RNS
The company news service from the London Stock Exchange