Update on LupuzorT Pivotal Phase III Study

RNS Number : 3263V

Immupharma PLC

02 November 2017

 

	2 November 2017

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 as at 1^st November 2017

·   200 patients successfully recruited and randomised (dosed)

o  all patients in the study have now passed the 9 months stage

o  116 of patients (58%) have completed 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:  "The trial continues to progress on track and on time, with all patients in the study now having passed the 9 month stage and 116 patients (58%) having completed the full 12 months.

"Most importantly, we continue to see robust safety within the study which is as equally important as the efficacy profile, in order for Lupuzor™ to be proactively prescribed by specialists to Lupus patients, who urgently require a more effective treatment for their condition.

"We look forward with confidence to reporting top line results of the study in Q1 2018."

For more information on the trial please visit: https://clinicaltrials.gov/ct2/show/NCT02504645 

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:

https://clinicaltrials.gov/ct2/show/NCT02504645 

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 $30,000 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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