US PATIENTS COMMENCE DOSING IN PHASE III STUDY

RNS : FOR IMMEDIATE RELEASE

15 FEBRUARY 2016

 

 

FIRST US PATIENTS COMMENCE DOSING IN LUPUZOR'S PIVOTAL PHASE III STUDY

 

 

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.

 

ImmuPharma is pleased to confirm that the first US sites opened in December 2015 have now commenced dosing patients. Recruitment in this pivotal Phase III study for Lupuzor™ will occur in up to 45 investigator sites. 10 sites in United States and 35 in Europe.

 

Further updates on the progression of the Lupuzor™ Phase III trial will be announced, as appropriate, as the trial progresses. Progress on the trial can also be seen at: www.ClincialTrials.gov/lupuzor.

 

Commenting on the event, Tim McCarthy, Chairman, said: "This is the next key milestone for ImmuPharma's Lupuzor™ trial and we are therefore delighted that following the initial US sites being opened, we can now confirm that the first Lupus patients have commenced dosing. With recruitment going to plan, we look forward to providing further positive updates on this Lupuzor™ Phase III study as it progresses throughout this year and 2017."

 

-Ends-

For further information please contact:   ImmuPharma plc (www.immupharma.org) + 44 (0) 20 7152 4080 Tim McCarthy, Chairman Lisa Baderoon, Head of Investor Relations Twitter: @immupharma           + 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

 

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.

 

ImmuPharma announced on 5 February 2016 the successful completion of a conditional £8.3 million fund raise, comprising a Placing and Subscription. Completion of the Placing, Subscription and the Sharing Agreement remains subject, inter alia, to the approval of the Resolutions at a General Meeting to be held at 10 a.m. on 22 February 2016. For more information please go to: www.immupharma.org/aimrule26/circulars.

 

Lupuzor^TM

 

Lupuzor^TM (also referred to as forigerimod, rigerimod, IPP-201101 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 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