TIDMIMM
RNS Number : 7400D
Immupharma PLC
28 June 2019
28 June 2019
ImmuPharma PLC
("ImmuPharma" or the "Company")
Primary endpoint successfully met from the open label extension
study evaluating safety and tolerability from the Pivotal Phase III
trial of Lupuzor(TM) in patients with
Systemic Lupus Erythematosus ("Lupus")
Study demonstrates robust safety profile of Lupuzor(TM) with no
'serious adverse events' reported
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to announce analysis of the results
from the open label six month extension study from its original
Pivotal Phase III trial of Lupuzor(TM), its lead programme for the
potential breakthrough compound for Lupus, a potentially life
threatening auto-immune disease.
Key highlights:
-- 62 eligible patients enrolled throughout the US and Europe
completing a 24 week treatment period
-- Primary endpoint successfully achieved confirming the safety profile of Lupuzor(TM)
-- No 'serious adverse events' related to Lupuzor(TM) reported
-- As the study is an open label study, only descriptive efficacy data will be produced
Background
Following requests from both Investigators and patients involved
in the Pivotal Phase III study, ImmuPharma initiated an additional
study in January 2018, permitting patients who participated in the
Phase III study, to receive Lupuzor(TM) (plus "Standard of Care")
for six months in an open label scheme. Results were gathered as an
"extension" open label study, independent of the Pivotal Phase III
trial, with the primary endpoint being to evaluate safety and
tolerability.
Study Objectives
Primary Objective: The primary objective of the study extension
was to evaluate the safety and tolerability of a 200 microgram
("mcg") dose every 4 weeks for 24 weeks of Lupuzor(TM) in patients
with Lupus who had participated in the Pivotal Phase III study.
Outcome: The primary endpoint was successfully met, confirming
the outstanding and robust safety profile of Lupuzor(TM) whilst
also reporting no serious adverse events.
Secondary Objectives: The secondary efficacy objectives of the
study extension were to evaluate the following:
-- The effect of Lupuzor(TM) in the Clinical SLEDAI-2K total
score at final visit compared to initial visit
-- Remission of the disease (i.e. : reduction of clinical SLEDAI-2K score to 0)
Outcome:
-- 36% of patients were responders considering a clinical
response as a SLEDAI-2K Clinical score of 0 or a reduction of at
least 4 points in the SLEDAI-2K clinical score.
-- 32% of patients were in remission considering a clinical
response as a SLEDAI-2K Clinical score of 0
*A clinical SLEDAI-2K is defined as SLEDAI-2K score excluding
anti-dsDNA and complement (blood analysis) input.
Further announcements will be made as appropriate.
Commenting on the results, Dr Robert Zimmer MD, PhD, Chief
Scientific Officer said: "With the positive outcome of this open
label extension study with Lupuzor(TM) having met its primary
endpoint and confirming the robust safety profile of the drug, we
continue in our discussions with our regulatory experts and
potential partners with the key focus of moving Lupuzor(TM)
forward."
Tim McCarthy, Chairman added: ""We are delighted that
Lupuzor(TM) has again confirmed its robust safety profile and we
are confident that Lupuzor(TM) has the potential to bring a much
needed treatment to Lupus sufferers around the world. We look
forward to providing our shareholders with further updates as and
when appropriate."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
ImmuPharma PLC (www.immupharma.com) + 44 (0) 207 152 4080
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin +44 (0) 203 368 8974
Vassil Kirtchev
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes +44 (0) 203 815 8880
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
Notes to Editors
About ImmuPharma plc
ImmuPharma (AIM: IMM) is a pharmaceutical development company
listed since 2006 on AIM of the London Stock Exchange 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.
About 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) Phase III Trial
The completed Pivotal Phase III clinical trial was 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". Top line data was announced on 17
March 2018. The data showed that Lupuzor(TM) demonstrated a
superior response rate over placebo (52.5% vs 44.6% "responders")
in the primary analysis on the Full Analysis Set of all 202
patients. Importantly the study confirmed the outstanding safety
profile of Lupuzor(TM), with no serious adverse events being
reported. However, due to the high response rate in the placebo
group, this superior response did not allow statistical
significance to be reached (p = 0.2631) and the trial's primary end
point was not met. For more information go to:
http://www.immupharma.co.uk/top-line-results-lupuzor-pivotal-phase-iii-trial.
DEFINITIONS
Open Label Study
An open-label trial, or open trial, is a type of clinical trial
in which both the researchers and participants know which treatment
is being administered. In this case, Lupuzor(TM).
Standard of Care
"Standard of Care" includes treatment with other drugs such as
steroids, anti-malarials, methotrexate etc.
SLEDAI-2K Clinical Score
Systemic Lupus Erythematosus Disease Activity Index 2000
Anti- dsDNA Autoantibodies
Anti-dsDNA autoantibodies is a recognised biomarker for Systemic
Lupus Erythematosus (Lupus)
Serious Adverse Event
A serious adverse event is an adverse event occurring at any
dose that results in any of the following outcomes or actions: --
death -- a life-threatening adverse event (ie, the patient was at
immediate risk of death from the event as it occurred); does not
include an event that, had it occurred in a more severe form, might
have caused death -- inpatient hospitalization or prolongation of
existing hospitalization -- a persistent or significant
disability/incapacity (refers to a substantial disruption of one's
ability to conduct normal life functions) -- a congenital
anomaly/birth defect -- an important medical event that may not
result in death, be life-threatening, or require hospitalization,
but may jeopardize the patient and may require medical intervention
to prevent 1 of the outcomes listed in this definition
For more information, please visit www.immupharma.co.uk
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END
MSCUBSRRKSANUUR
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