Last checked at 17 May 2017 07:00
17 MAY 2017
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ImmuPharma PLC
("ImmuPharma" or the "Company")
Update on Lupuzor™ Pivotal Phase III Study
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to provide an update of its pivotal 52-week, randomised, double-blinded, Phase III clinical trial of Lupuzor™, its lead programme for the potential breakthrough compound for Lupus, the life threatening auto-immune disease.
Study Summary
· 200 patients successfully recruited and randomised (dosed)
· 7 Countries and 28 sites are participating in the study
o US: 11 sites with 70 patients
o Europe: 5 Countries and 16 sites with 81 patients
o Mauritius: 1 site with 49 patients
· Study status as at end-April 2017
o all 200 patients have passed the 3 months stage
o over 80% of patients (166) have passed 6 months
o 49 patients have passed the 9 months stage
o 28 patients have passed the full 12 months of the study
· Continued robust safety record which remains consistent with Lupuzor™'s product profile as shown in its previous Phase IIb study
· Top line results remain on track to be reported in Q1 2018
Commenting on the trial update, Tim McCarthy, Chairman of ImmuPharma said: "We are delighted to provide a further update of our pivotal Phase III study of Lupuzor™ in Lupus.
Putting this data into context, key milestones have been achieved with all 200 patients passing the three months stage whilst 28 patients have now passed the full 12 months of the study. We are now in important new territory with over 80% of patients having had exposure to Lupuzor™ for over six months, compared to our Phase IIb three month study, whilst still maintaining an excellent safety profile.
With the study on track to report top line results in Q1 2018, we look forward to providing shareholders with further updates on this pivotal Phase III study as it progresses through 2017."
For more information on the trial please visit: www.ClinicalTrials.gov/lupuzor
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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.
Lupuzor™
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
Commercial Opportunity
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