TIDMIMM
RNS Number : 0128V
Immupharma PLC
25 January 2017
25 JANUARY 2017
ImmuPharma PLC
("ImmuPharma" or the "Company")
Update on Lupuzor(TM) Pivotal Phase III Study
Full Analysis of Patient Recruitment
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to provide further details of
patient participation following confirmation (as announced on 22
December 2016) that the Company had successfully completed, on
target, patient recruitment into its pivotal 52-week 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)
o 293 patients initially screened illustrating the demand from
physicians for a new safe and effective treatment for Lupus
-- 7 Countries and 28 sites are participating in the study
o US: 11 sites with 70 patients randomised
o Europe: 5 Countries and 16 sites with 81 patients
randomised
o Mauritius: 1 site with 49 patients randomised
-- Study status as at the end of January 2017
o over 80% of patients will have been treated for at least 3
months
o 2 patients have completed the study
o 24 patients will have been treated for 9 months
o 50 patients will have been treated for 6 months
o 90 patients will have been treated for 3 months
-- To date no drug (active or placebo) related 'Serious Adverse
Events' have been reported. This is consistent with the strong
safety profile of Lupuzor(TM) shown in its earlier Phase IIb
study
-- Top line results are estimated to be reported in Q1 2018
Commenting on this trial, Tim McCarthy, Chairman of ImmuPharma
said: "We are delighted to be able to now provide more details
involved in the completion of recruitment of patients within our
Lupuzor(TM) pivotal Phase III trial in Lupus.
Putting the data into context, 293 patients were initially
screened in this study. We believe this illustrates the demand from
physicians to meet the unmet medical need, for an effective and
safe treatment for this debilitating and life threatening
disease.
With the trial on track and two patients already safely
completing their 12 month dosing regimen, we look forward to
providing further updates on this pivotal Phase III trial as it
progresses through 2017."
Dr. Robert Zimmer, President & Chief Scientific Officer
added: "Thanks to the diligent work performed by Dr. Fanny Valleix,
Head of Clinical Research at ImmuPharma in conjunction with
Simbec-Orion, our contract research partner, we achieved our goal
to complete patient recruitment before the end of 2016.
Again it is important to note that no drug (active or placebo)
related serious adverse events have been recorded to date which is
consistent with the strong safety profile of Lupuzor(TM) shown in
our earlier Phase IIb trial."
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,
Michael Mackintosh, 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
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