Update on LupuzorT Pivotal Phase III Study

RNS Number : 5921J

Immupharma PLC

30 June 2017

 

	30 JUNE 2017

ImmuPharma PLC

("ImmuPharma" or the "Company")

Update on Lupuzor™ Pivotal Phase III Study

Annual General Meeting and Investor Presentation : Today starting at 10.30am

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. This is in advance to the Company's Annual General Meeting (AGM) which will be held later today at 10:30am at Sky Light City Tower, 50 Basinghall Street, EC2V 5DE.

ImmuPharma will also be hosting an Investor Presentation and luncheon immediately following the AGM at 11.30am. Vadim Alexandre, Northland Capital Partners' Healthcare Analyst will also give a short presentation. A video of the presentation will be available to view on the Company's website from Monday 3 July 2017 on: http://www.immupharma.org/events/2017. Please contact Lisa Baderoon at [e-mail] if you would like to attend this event.

·         Study summary as at end-June 2017

·   200 patients successfully recruited and randomised (dosed)

o  all 200 patients have passed the 3 months stage

o  over 90%  of patients (184) have passed 6 months

o  81 patients (40%) have passed the 9 months stage

o  46 patients (23%) 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 pleased to provide a further update of our pivotal Phase III study of Lupuzor™ in Lupus showing that approximately a quarter of the patients have now completed the full 12 months of the trial and almost all the patients have completed six months. As the trial continues to progress, we are delighted to observe the continuation of our robust safety record, as Lupuzor™ is being administered to greater numbers of patients over a longer period of time.

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 the second half of 2017.

We are also delighted that following our AGM being held later today, we will be hosting an Investor Presentation which will provide the Board with an opportunity of talking through the Lupuzor™ trial as well providing further details on the other clinical development products in our pipeline."

For more information on the trial please visit: www.ClinicalTrials.gov/lupuzor

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

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 Northland Capital Partners Limited (NOMAD & Broker) Patrick Claridge, David Hignell, Jamie Spotswood, Corporate Finance Rob Rees, Corporate Broking [phone]

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

 

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