UPDATE ON LUPUZOR'S PIVOTAL PHASE III STUDY

RNS : FOR IMMEDIATE RELEASE

7 SEPTEMBER 2016

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

UPDATE ON LUPUZOR'S PIVOTAL PHASE III STUDY

 

ImmuPharma Invited to Open an Additional Site in Mauritius

Up to 30 Lupus patients ready for enrolment

 

ImmuPharma PLC (LSE:IMM), 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 has been requested to open a new site in Mauritius to participate in the current pivotal Phase III Lupuzor™ trial. Cap Research, a leading contract research organisation in Mauritius, will be leading the trial and patient recruitment. It is anticipated that around 30 Lupus patients will commence recruitment within this new site over the next few weeks as part of the ongoing 200 patient Lupuzor™ trial.

 

Mauritius, with a population of around 1.2 million, is prevalent to a high proportion of Lupus sufferers, with approximately 3000 current Lupus patients. In May 2016, Prof. Sylviane Muller, inventor of Lupuzor™, was invited to visit Mauritius as a guest of 'Lupus Alert', the country's pre-eminent Lupus foundation which has been following the progress of Lupuzor™ since the commencement of its pivotal Phase III trial.

 

Over one week, Prof. Muller had an audience with Ameenah Gurib-Fakim, Mauritius' President and a prominent scientist. Prof. Muller also met with high ranking government officials, leading Rheumatologists and the Ministry of Health, which is responsible for approving clinical trials in the country, delivering presentations. TV/radio interviews on Lupuzor™ were also conducted. Discussions focused primarily on the Government's strong interest for ImmuPharma to include Mauritius in its current pivotal Phase III trial for Lupuzor™.

 

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

 

Commenting on the announcement, Tim McCarthy, Chairman, said: "We are delighted to have been requested by the Mauritian Government and the Country's leading Lupus specialists to participate in our trial. Mauritius with its high proportion of Lupus sufferers clearly highlights how necessary an effective Lupus therapy such as Lupuzor™ is needed for such a debilitating disease. We look forward to providing further positive updates on our Lupuzor™ Phase III study as it progresses further through this year and into 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   Northland Capital Partners Limited (Joint Broker) Patrick Claridge, David Hignell, Corporate Finance Rob Rees, Corporate Broking                                                +44 (0)20 3861 6631

 

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

 

About Lupus Alert (www.lupusalert.com)

Lupus Alert is the only registered Non Government Organisation (NGO) that provides active physical, moral, emotional and financial support to patients and families with Lupus and other related autoimmune diseases in Mauritius. Founded in January 2000, Lupus Alert has been applauded for its pioneering work and vision:

·      Lupus Alert was awarded the Mauritius Council of Social Service Outstanding NGO Award in 2003 and the most Outstanding Volunteer Award by the Mauritius Council of Youth Leaders in 2004 and in 2009.

·      Lupus Alert received the International Lifetime Achievement Award in the control of Systemic Lupus Erythematosus (SLE) on 26^th June 2010 during the 9^thInternational Congress on SLE held in Vancouver.

·      For her extraordinary work in disease awareness and patient advocacy Dalilah Kalla, a lupus patient, was awarded the 2011 JCI Outstanding Young Person of Mauritius and is among the 2011 JCI Ten Outstanding Young Persons of the World (JCI TOYP) recipient in the category of humanitarian and voluntary leadership.

·      Over 3000 people may have lupus in Mauritius and 90% of those affected are teenagers and young adults between the ages of 10 and 35 years.

·      Lupus Alert's vision is to make sure that all people with lupus in Mauritius have guaranteed access to competent health care, high quality treatment and are ensured all support required to live a comfortable life.

 

 

About Cap Research (www.cap-research.com)

 

Cap Research is a CRO (Clinical Research Organisation), based at Phoenix (Mauritius), conducting medical and clinical trials phases I, II and III. Incorporated since 2013, its research centre is synonymous of excellence and has the know-how whilst using the latest technical development in the field of clinical research. It is the first private trial research centre in Mauritius performing studies for phases I, II and III.