Immupharma PLC Update on Lupuzor Phase III Study (3534F)
May 17 2017 - 2:00AM
UK Regulatory
TIDMIMM
RNS Number : 3534F
Immupharma PLC
17 May 2017
17 MAY 2017
ImmuPharma PLC
("ImmuPharma" or the "Company")
Update on Lupuzor(TM) 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(TM), its lead programme for the potential breakthrough
compound for Lupus, the life threatening auto-immune disease.
Study Summary
-- 200 patients successfully recruited and randomised (dosed)
-- 7 Countries and 28 sites are participating in the study
o US: 11 sites with 70 patients
o Europe: 5 Countries and 16 sites with 81 patients
o Mauritius: 1 site with 49 patients
-- Study status as at end-April 2017
o all 200 patients have passed the 3 months stage
o over 80% of patients (166) have passed 6 months
o 49 patients have passed the 9 months stage
o 28 patients have passed the full 12 months of the study
-- Continued robust safety record which remains consistent with
Lupuzor(TM)'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 delighted to provide a further update of
our pivotal Phase III study of Lupuzor(TM) in Lupus.
Putting this data into context, key milestones have been
achieved with all 200 patients passing the three months stage
whilst 28 patients have now passed the full 12 months of the study.
We are now in important new territory with over 80% of patients
having had exposure to Lupuzor(TM) for over six months, compared to
our Phase IIb three month study, whilst still maintaining an
excellent safety profile.
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 2017."
For more information on the trial please visit:
www.ClinicalTrials.gov/lupuzor
-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
Northland Capital Partners Limited
(Joint Broker)
Patrick Claridge, David Hignell,
Corporate Finance +44 (0)20 3861
Rob Rees, Corporate Broking 6625
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
RESMMGMKMVDGNZZ
(END) Dow Jones Newswires
May 17, 2017 02:00 ET (06:00 GMT)
Immupharma (LSE:IMM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Immupharma (LSE:IMM)
Historical Stock Chart
From Apr 2023 to Apr 2024