FOR IMMEDIATE RELEASE
14 SEPTEMBER 2016
("ImmuPharma" or the "Company")
UPDATE ON LUPUZOR'S PIVOTAL PHASE III STUDY
11 US Sites Now Open
5 European Countries Now Recruiting
ImmuPharma PLC (LSE:IMM), 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.
Key Trial Highlights
· Total 11 sites now active in US
· 5 European countries now recruiting Lupus patients in Czech Republic, France, Germany, Hungary and Poland
· The final 2 European countries, UK and Italy, to open within the next few weeks
· Mauritius site already confirmed that over 10 Lupus patients have been pre-screened prior to dosing
Further updates on the progression of the Lupuzor™ Phase III trial will be announced, as appropriate, as the trial progresses. Trial progress can also be viewed at: www.ClinicalTrials.gov/lupuzor.
Commenting on the announcement, Tim McCarthy, Chairman, said: "We are delighted by the continued progress of the Lupuzor™ Phase III trial both with the US now having the full 11 sites active and the opening of further countries across Europe. Additionally, we are encouraged following the announcement last week of the opening of a new site in Mauritius, that we have already commenced screening a number of Lupus patients in advance of first dosing. The key milestone this year remains for the completion of the recruitment of the 200 Lupus patients into the trial and we look forward to providing further positive updates on this Lupuzor™ Phase III study as it progresses throughout this year and 2017."
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Notes to Editors
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.
Lupuzor™ (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™ 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™ 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 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". 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"). For more information please visit: www.ClinicalTrials.gov/lupuzor
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. GSK's Benlysta is the first Lupus drug approved in over 50 years and paves the path to market for Lupuzor™. Based on conservative estimates, and taking into account that Benlysta is priced currently at approximately $35,000 per patient per year, Lupuzor™ would be entering a market with the potential for multi-billion dollar sales. For more information on Lupuzor™ please visit: www.lupuzor.com
This information is provided by RNS