Positive Final Lupuzor Trial Results
November 19 2009 - 2:00AM
UK Regulatory
TIDMIMM
RNS Number : 7400C
Immupharma PLC
19 November 2009
Conference Call
ImmuPharma will host a conference call for analysts and investors to discuss
this announcement at 15:45 GMT / 10:45 EST / 07:45 PST today. The dial-in
details are: +44 (0)20 8609 1435 or US toll free: 1 866 793 4279, participant
PIN code 311368#.
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| FOR IMMEDIATE RELEASE | 19 NOVEMBER 2009 |
+------------------------------------+------------------------------------+
ImmuPharma PLC
("ImmuPharma")
Encouraging FINAL PHASE IIb RESULTS seen with LUPUZOR(TM)
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(TM) in active patients with Systemic Lupus
Erythematosus (SLE). Lupuzor(TM) 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(TM) was generally
well tolerated, with adverse event rates lower with Lupuzor(TM) when compared to
placebo.
Highlights
* Lupuzor(TM) 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(TM) 200 µg every 4 weeks for 12 weeks compared to 41% on placebo
* Lupuzor(TM) was generally well tolerated with fewer serious AEs leading to
discontinuation
Details of the Phase IIb study with Lupuzor(TM)
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(TM) 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(TM)
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 = 6. Soon
after study commencement the protocol was formally amended to ensure only
patients with a clinical SLEDAI = 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(TM)
The analysis of the study revealed for Week 12:
1) ITT population:
a) Primary endpoint (Combined score responders): Lupuzor(TM) once-a-month 53% (p
= 0.048). Lupuzor(TM) twice-a-month: 45%; placebo 36%
b) SLEDAI score responders: Lupuzor(TM) once-a-month 53% (p = 0.073).
Lupuzor(TM) twice-a-month: 45%; placebo 38%
2) Moderate to severe subgroup Population Week 12
a) Primary endpoints (Combined score responders): Lupuzor(TM) once-a-month 62%
(p = 0.016). Lupuzor(TM) twice-a-month: 48%; placebo 39%
b) SLEDAI score responders: Lupuzor(TM) once-a-month 62% (p = 0.026).
Lupuzor(TM) twice-a-month: 48%; placebo 41%
All treatments (Lupuzor(TM) or placebo) were administered in addition of
standard of care which may include patients on low dose steroids (< 80mg
prednisone/week). 200 µg of Lupuzor(TM) administered once-a-month during 3
months (total 600 µg) 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(TM) 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(TM) 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(TM) 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 Lupuzor(TM)'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 Lupuzor(TM).
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 | |
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| | |
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| 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 $500m in milestone payments in addition to significant
royalties. $45m in cash has been received to date - $15m in Q4 2008 and $30m
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
END
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