FOR IMMEDIATE RELEASE |
7 DECEMBER 2015 |
LUPUZOR™ PIVOTAL PHASE III TRIAL RECRUITING FIRST US LUPUS PATIENTS
ImmuPharma PLC (LSE:IMM), ("ImmuPharma" or the "Company"), the specialist drug discovery and development company, is pleased to provide a further 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 Company is pleased to confirm that the first US sites are open for recruitment of patients. This will be acknowledged on the U.S. National Institutes of Health - ClincialTrials.gov website shortly.
Recruitment in this pivotal Phase III study for Lupuzor™ 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. This trial is due to be completed by the end of 2017.
Further updates on the progression of the Lupuzor™ Phase III trial will be announced, as appropriate, as the trial progresses.
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 |
Panmure, Gordon & Co., NOMAD & Broker |
+44 (0) 20 7886 2500 |
Fred Walsh, Duncan Monteith, Corporate Finance Charles Leigh-Pemberton, Corporate Broking |
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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
LupuzorTM
LupuzorTM 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. LupuzorTM 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.
LupuzorTM 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. 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
