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FOR IMMEDIATE RELEASE 19 NOVEMBER 2009
ImmuPharma PLC
("ImmuPharma")
ENCOURAGING FINAL PHASE IIb RESULTS SEEN WITH LUPUZOR™
IN SYSTEMIC LUPUS ERYTHEMATOSUS
~ Greatest benefits seen in patients with moderate to severe
Systemic Lupus Erythematosus ~
ImmuPharma PLC (LSE : IMM ) the specialist discovery and development
pharmaceutical company is pleased to announce today the final results
from a Phase IIb trial of LUPUZOR™ in active patients with Systemic
Lupus Erythematosus (SLE). Lupuzor™ administered at 200 mcg once-a-
month for 3 months plus standard of care achieved a clinically
significant improvement in patient response rate as measured by the
combined score compared to placebo plus standard of care. The study
results also show that Lupuzor™ was generally well tolerated, with
adverse event rates lower with Lupuzor™ when compared to placebo.
Highlights
. Lupuzor™ achieved a clinically significant improvement in patient
response rate versus placebo in the intention to treat (ITT)
analysis
. The improvement was statistically significant in a subgroup (90% of
the ITT population) of moderate to severe patients
. 62% of this sub-group of patients were responders according to both
a composite clinical score and a decrease of 4 points of the SLEDAI
score when treated with Lupuzor™ 200 (micro)g every 4 weeks for
12 weeks compared to 41% on placebo
. Lupuzor™ was generally well tolerated with fewer serious AEs
leading to discontinuation
Details of the Phase IIb study with Lupuzor™
This phase IIb study was a randomized, double-blind placebo controlled,
dose-ranging study in 150 (initially planned 204) patients designed to
evaluate the efficacy of Lupuzor™ in a three-month treatment period
of either subcutaneous (SC) injection of 200 mcg once-a-month (4qw) or
200 mcg twice-a-month (2qw) or placebo in addition to standard of care
and followed by a 3 month follow-up period.
The primary efficacy endpoint of the study was based on the combined
score, which is defined by: (1) a reduction from baseline of at least 4
points on the 2K-SLEDAI disease activity scale (which indicates a
clinically important reduction in SLE disease activity); (2) no
worsening of disease as measured by the Physician's Global Assessment
(worsening defined as an increase of 0.30 points or more from
baseline); and (3) no new BILAG A organ domain score (which indicates a
severe flare of lupus disease activity) and no more than one new BILAG
B organ domain score (which indicates a moderate flare of disease
activity). An additional end-point was the response rate based only on
the decrease of the SLEDAI score by 4 points.
An interim analysis was performed and included 125 patients out of the
ITT population having completed by mid November 2008 the week 12
assessments, approximately half of them having also completed the 12
week follow-up period. These results were announced in January 2009
indicating that Lupuzor™ administered at a 200 mcg dose once-a month
for 3 months was statistically significantly superior to placebo, using
a decrease of 4 points of the SLEDAI score to define a responder with
drop-outs being considered according to the protocol as non-responders.
As the study showed a statistically significant improvement even with a
much lower number of patients, ImmuPharma decided to stop the
recruitment of further patients. All patients already recruited
completed the study according to protocol.
The study was planned to originally enroll any patient with SLEDAI
greater than or equal to 6. Soon after study commencement the protocol
was formally amended to ensure only patients with a clinical SLEDAI
greater than or equal to 6 (defined as the moderate to severe subgroup)
were included.
The study was terminated with an ITT population of 147 patients (Intent
To Treat population) and the moderate to severe subgroup of 134
patients (90% of the ITT population) in line with the amended protocol.
Key findings from the Phase IIb study with Lupuzor™
The analysis of the study revealed for Week 12:
1) ITT population:
a) Primary endpoint (Combined score responders): Lupuzor™ once-a-
month 53% (p = 0.048). Lupuzor™ twice-a-month: 45%; placebo
36%
b) SLEDAI score responders: Lupuzor™ once-a-month 53% (p =
0.073). Lupuzor™ twice-a-month: 45%; placebo 38%
2) Moderate to severe subgroup Population Week 12
a) Primary endpoints (Combined score responders): Lupuzor™ once-
a-month 62% (p = 0.016). Lupuzor™ twice-a-month: 48%; placebo
39%
b) SLEDAI score responders: Lupuzor™ once-a-month 62% (p =
0.026). Lupuzor™ twice-a-month: 48%; placebo 41%
All treatments (Lupuzor™ or placebo) were administered in addition of
standard of care which may include patients on low dose steroids (less
than 80mg prednisone/week). 200 (micro)g of Lupuzor™ administered
once-a-month during 3 months (total 600 (micro)g) achieved a clinically
and statistically meaningful improvement of the moderate to severe
subgroup. An analysis after a further 12 week follow-up (with only
standard of care) revealed that the responder rates further increased
to reach about 70% in the moderate to severe subgroup compared to 59%
on placebo. Lupuzor™ was well tolerated and its safety profile was
better than placebo with less drop-outs (1 vs 8) and less serious AEs
leading to discontinuation.
Lupus is a disease that involves an inappropriate functioning of the
immune system in that the immune-competent T and B cells are generating
antibodies against certain self proteins. Lupuzor™ corresponds to
the sequence 131-151 of the 70k snRNP protein with a Serine
phosphorylated in position 140. It was discovered by France's National
Center for Scientific Research (Centre National de la Recherche
Scientifique) and further developed by ImmuPharma and is now licensed
to Cephalon Inc. Lupuzor™ modulates both the auto-reactive T and B
cells involved in Lupus in order to render the functioning of the
immune system more appropriate while maintaining its overall efficacy.
Commenting on the detailed results of the study, Dr Robert Zimmer, MD.
PhD, ImmuPharma's President and Chief Scientific Officer said: "We are
absolutely delighted that LupuzorTM's phase IIb study has delivered
such very encouraging clinical efficacy data reaching statistical
significance in the moderate to severe subgroup (90% of the ITT
population) and with an overall efficacy peaking at 70%. The
information gathered in this study, in addition to the very small
number patients needed to prove efficacy, paves the way for a medical
and commercial success of LupuzorTM.
Frank Baldino Jr, Ph.D, Cephalon's Chairman & CEO added: "We are
pleased to have the opportunity to further develop Lupuzor and
potentially bring a new medication to the lupus patients who have
waited 50 years for new therapy."
- Ends -
For further information please contact:
ImmuPharma PLC +44 20 7152 4080
Dimitri Dimitriou, Chief Executive Officer +33 3 8932 7650
Robert Zimmer, President and Chief Scientific Officer
Richard Warr, Chairman
Buchanan Communications +44 20 7466 5000
Lisa Baderoon / Catherine Breen
Panmure Gordon & Co (Nominated Adviser & Broker) +44 151 243 0963
Andrew Burnett
Rakesh Sharma
Noble & Company Limited (Joint Broker) +44 20 7763 2200
James Bromhead
Sam Reynolds
Notes to Editors
About ImmuPharma PLC
ImmuPharma is a drug discovery and development group with its key
operations in London and subsidiaries in Mulhouse, France and Basle,
Switzerland. The Company aims to develop novel drugs to treat serious
medical conditions for which there is a high unmet need. It has five
drugs in development to treat 1) Lupus, 2) Cancer, 3) Severe Pain, 4)
Highly resistant infections like MRSA and 5) Inflammatory and Allergic
disorders.
Its lead candidate for the treatment of Lupus, LupuzorTM, a chronic,
life-threatening autoimmune disease, was licensed to Cephalon, Inc in a
transaction worth up to USD500m in milestone payments in addition to
significant royalties. USD45m in cash has been received to date -
USD15m in Q4 2008 and USD30m post year end in Q1 2009.
ImmuPharma also has a strong proprietary and collaborative drug
development pipeline.
This information is provided by RNS
The company news service from the London Stock Exchange
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