Lupuzor Phase III Pivotal Trial Update

RNS Number : 5074E

Immupharma PLC

04 November 2015

 

FOR IMMEDIATE RELEASE

4th NOVEMBER 2015

LUPUZOR PHASE III PIVOTAL TRIAL UPDATE

ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to provide an update on the progress of its Phase III clinical trial of Lupuzor™, its lead programme for the potential breakthrough compound for Lupus, the life threatening auto immune disease.

The pivotal Phase III trial is progressing in conjunction with Simbec-Orion, the Company's contract research organisation conducting the study. A number of important operational and regulatory milestones have now been reached in order to allow the recruitment of the first patients into the study this year, particularly:

·    Recruitment is anticipated to occur in up to 45 investigator sites. 10 sites in United States and 35 in Europe to ensure the screening of 270 potential patients, in order to recruit the required 200 patients for the trial.

·    In the United States the trial has been approved by a major Central Institutional Review Board (IRB) which will allow several sites to participate through a single IRB. It is expected that the first sites in the US will be fully initiated in late November/early December and will commence recruiting patients thereafter.

·    In Europe the study is progressing through the centralised Voluntary Harmonisation Procedure (VHP).  The VHP application was submitted on 28 October 2015 and this has up to a 60 day review window.  The applications to local Ethics Committees will happen in parallel as well as the applications to the local EU Member states. The EU VHP sets out that the study will take place in the United Kingdom, Germany, France, Italy, Czech Republic, Hungary and Poland. In Europe it is expected that the first sites will become fully initiated in January and will then commence patient recruitment thereafter.

·    As an integral part of the study the 'Investigator Meeting' which will include around 100 investigators and senior coordinators from the USA and Europe, will be held in Paris on 11-12th December 2015. The meeting will be introduced by Mr Alain Fuchs, Président of the Centre National de la Recherche Scientifique (CNRS), ImmuPharma's scientific collaboration partner.

Further updates on the progression of the Lupuzor™ Phase III trial will be announced, as appropriate, as the trial progresses.

Tim McCarthy, Non-Executive Chairman of ImmuPharma said:

"Following my recent appointment as Chairman I have now had the opportunity to review the progress of the Phase III study with both the ImmuPharma development team and Simbec-Orion. I am confident that given the dedication and expertise of the ImmuPharma team combined with the experience of Simbec-Orion, the study will progress as planned with the anticipation of completing the study by the end of 2017."

Ronald Openshaw, CEO of Simbec-Orion further commented:

"We continue to work closely with the development team at ImmuPharma on the Lupuzor™ Phase III trial. Lupuzor™ has the potential to be a significant treatment for lupus sufferers globally and we are delighted to be contributing to its progress through this last stage of development."

Robert Zimmer, President and CSO of ImmuPharma added:

"Dr Fanny Valleix, our VP Clinical development at ImmuPharma France is leading the project. She brings her strong expertise gained from her past as project director at an international contract research organisation as well as an independent consultant. The Lupuzor™ project is in good hands."

For further information please contact:

ImmuPharma plc	+ 44 (0) 20 7152 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor Relations	+ 44 (0) 7721 413496
Simbec-Orion Ronald Openshaw, CEO Consilium Strategic Communications (Simbec-Orion) Mary-Jane Elliott, Ivar Milligan Panmure, Gordon & Co., NOMAD & Broker	[phone]  [phone] [phone]
Fred Walsh, Duncan Monteith, Corporate Finance Charles Leigh-Pemberton, Corporate Broking

Notes to Editors

ImmuPharma PLC 

ImmuPharma is a pharmaceutical development company listed since 2006 on AIM of the London Stock Exchange (LSE: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. For more information please go to: www.immupharma.org

Lupuzor^TM

Lupuzor^TM also referred to as rigerimod 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).  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 pivotal Phase III clinical study is titled "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". It is a pivotal study designed to demonstrate the safety and efficacy of IPP-201101 and as a last step prior to the filing of the drug for approval with the US Food & Drug Administration ("FDA") and the European Medicines Agency ("EMA").

Commercial Opportunity

Current drugs either have serious side effects or have limited effectiveness. GSK's Benlysta's approval paves the way for Lupuzor™ (first Lupus drug approved in over 50 years). There are an estimated 1.5 million patients in US, Europe and Japan. The target price per patient is estimated to be around $10,000 -$20,000 per year. For more information on Lupuzor™ please visit: (www.lupuzor.com)

Simbec-Orion

Simbec-Orion is a full service CRO operating from first in human Phase I clinical studies through to pivotal Phase III studies and Phase IV post marketing studies.  The Company has expertise in all drug types, dosage forms and delivery mechanisms and in later stage development has particular expertise in oncology, rare and orphan diseases.  Simbec-Orion supports its clients with its own in-house full service central laboratories, pharmacovigilance, data management and statistics, pharmacy, medical management. For more information please visit: www.simbec.com and www.orioncro.com

 

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