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25 JANUARY 2017
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ImmuPharma PLC
("ImmuPharma" or the "Company")
Update on Lupuzor™ Pivotal Phase III Study
Full Analysis of Patient Recruitment
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is pleased to provide further details of patient participation following confirmation (as announced on 22 December 2016) that the Company had successfully completed, on target, patient recruitment into its pivotal 52-week 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)
o 293 patients initially screened illustrating the demand from physicians for a new safe and effective treatment for Lupus
· 7 Countries and 28 sites are participating in the study
o US: 11 sites with 70 patients randomised
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· Study status as at the end of January 2017
o over 80% of patients will have been treated for at least 3 months
o 2 patients have completed the study
o 24 patients will have been treated for 9 months
o 50 patients will have been treated for 6 months
o 90 patients will have been treated for 3 months
· To date no drug (active or placebo) related 'Serious Adverse Events' have been reported. This is consistent with the strong safety profile of Lupuzor™ shown in its earlier Phase IIb study
· Top line results are estimated to be reported in Q1 2018
Commenting on this trial, Tim McCarthy, Chairman of ImmuPharma said: "We are delighted to be able to now provide more details involved in the completion of recruitment of patients within our Lupuzor™ pivotal Phase III trial in Lupus.
Putting the data into context, 293 patients were initially screened in this study. We believe this illustrates the demand from physicians to meet the unmet medical need, for an effective and safe treatment for this debilitating and life threatening disease.
With the trial on track and two patients already safely completing their 12 month dosing regimen, we look forward to providing further updates on this pivotal Phase III trial as it progresses through 2017."
Dr. Robert Zimmer, President & Chief Scientific Officer added: "Thanks to the diligent work performed by Dr. Fanny Valleix, Head of Clinical Research at ImmuPharma in conjunction with Simbec-Orion, our contract research partner, we achieved our goal to complete patient recruitment before the end of 2016.
Again it is important to note that no drug (active or placebo) related serious adverse events have been recorded to date which is consistent with the strong safety profile of Lupuzor™ shown in our earlier Phase IIb trial."
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
This information is provided by RNS