Immupharma PLC UPDATE ON LUPUZOR'S PIVOTAL PHASE III STUDY (7530J)
14 September 2016 - 4:00PM
UK Regulatory
TIDMIMM
RNS Number : 7530J
Immupharma PLC
14 September 2016
FOR IMMEDIATE RELEASE 14 SEPTEMBER 2016
ImmuPharma PLC
("ImmuPharma" or the "Company")
UPDATE ON LUPUZOR'S PIVOTAL PHASE III STUDY
11 US Sites Now Open
5 European Countries Now Recruiting
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(TM), its lead
programme for the potential breakthrough compound for Lupus, the
life threatening auto-immune disease.
Key Trial Highlights
-- Total 11 sites now active in US
-- 5 European countries now recruiting Lupus patients in Czech
Republic, France, Germany, Hungary and Poland
-- The final 2 European countries, UK and Italy, to open within the next few weeks
-- Mauritius site already confirmed that over 10 Lupus patients
have been pre-screened prior to dosing
Further updates on the progression of the Lupuzor(TM) Phase III
trial will be announced, as appropriate, as the trial progresses.
Trial progress can also be viewed at:
www.ClinicalTrials.gov/lupuzor.
Commenting on the announcement, Tim McCarthy, Chairman, said:
"We are delighted by the continued progress of the Lupuzor(TM)
Phase III trial both with the US now having the full 11 sites
active and the opening of further countries across Europe.
Additionally, we are encouraged following the announcement last
week of the opening of a new site in Mauritius, that we have
already commenced screening a number of Lupus patients in advance
of first dosing. The key milestone this year remains for the
completion of the recruitment of the 200 Lupus patients into the
trial and we look forward to providing further positive updates on
this Lupuzor(TM) Phase III study as it progresses throughout this
year and 2017."
-Ends-
For further information please
contact:
+ 44 (0) 20
ImmuPharma plc (www.immupharma.org) 7152 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor
Relations + 44 (0) 7721
Twitter: @immupharma 413496
Panmure, Gordon & Co., (NOMAD +44 (0) 20
& Broker) 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 +44 (0)20 3861
Rob Rees, Corporate Broking 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(TM)
Lupuzor(TM) (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(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(TM). Based on conservative estimates, and taking into
account that Benlysta is priced currently at approximately $35,000
per patient per year, Lupuzor(TM) would be entering a market with
the potential for multi-billion dollar sales. For more information
on Lupuzor(TM) please visit: www.lupuzor.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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