TIDMIMM
RNS Number : 2772X
Immupharma PLC
19 December 2023
19 December 2023
ImmuPharma PLC
("ImmuPharma" or the "Company")
Simbec-Orion appointed as CRO | Decision to move directly into a
Phase 3 pivotal study |
Compelling findings on P140's MOA
ImmuPharma PLC (LSE AIM: IMM), the specialist drug discovery and
development company, is pleased to announce key updates on its late
stage P140 (Lupuzor(TM)) program, in patients with systemic lupus
erythematosus ("SLE/Lupus").
Highlights
-- Simbec-Orion has been appointed as the Contract Research
Organisation ("CRO"), for the P140 (Lupuzor(TM)) Phase 3 study in
SLE, following extensive due-diligence and a six month tender
process, involving 3 different CROs. This was conducted by
ImmuPharma's clinical team and agreed with its US partner, Avion
Pharmaceuticals, LLC ("Avion")
-- In addition, ImmuPharma and Avion consider that a Phase 3
dose-ranging study, rather than the longer Phase 2/3 adaptive study
is preferable. The direct Phase 3 route is faster to filing for
approval whilst also incorporating FDA's request for demonstration
of a dose-ranging in the pivotal program.
-- The international Phase 3 dose-ranging study design and
protocol is substantially different from previous clinical trials
completed by ImmuPharma. Dosing will still be a subcutaneous
injection, once a month, but with significantly higher doses, which
have demonstrated safety and tolerability as part of the clinical
program. Two planned interim analyses during the course of the
study will allow early indications of the effectiveness of
P140.
-- Recent further insights into P140's mechanism of action
("MOA") supports its position as the only non-immunosuppressing
molecule in clinical development in the industry. A new potential
standard of care for SLE sufferers.
-- As the study continues to move forward in 2024, further
details on the study's timings, protocol and key elements of the
clinical trial design will be communicated at regular
intervals.
Appointment of Simbec-Orion as CRO
Simbec-Orion, is an experienced, full-service Contract Research
Organisation, with offices across UK, Europe, and the United
States, specialising in Rare & Orphan conditions. Simbec-Orion
has previous direct experience in Lupus trials including conducting
ImmuPharma's last Phase 3 study completed in 2018 and more recently
conducted ImmuPharma's Pharmacokinetics (" PK") study completed in
2022.
P140 (Lupuzor(TM)) New study dosing , design and MOA
The whole P140 program was re-examined in 2021, and the Board
decided that it required a completely different approach, not only
to commence a new Phase 3 study in Lupus, but also to be clear on
the product offering and target product profile. The three pillars
of strength and confidence in our new program are dose, design and
MOA.
Dose
After three FDA guidance meetings, further human and animal
pharmacokinetics studies and reconciliation with efficacy
demonstrated in the animal models, it was concluded that the
previous dose used in clinical studies was too low. The new Phase 3
study will include dose-ranging up to 15 times higher than the
original study dose of 200 micrograms.
Design
The design of the pivotal Phase 3 study includes a dose-range.
This design is faster to complete than a Phase 2/3 adaptive study,
while at the same time incorporating all the key objectives. We
confidently expect the efficacious dose to be within this
dose-range and we expect no adverse events that could lead to
product label warnings seen with all other approved drugs and
standard of care, which are all immunosuppressants. The study
design allows two interim analyses, so there will be short term
updates on clinical activity of the drug. P140 is not an
immunosuppressant, so a key objective will be to taper the use of
steroids which are currently standard of care. The study will also
include analysis of certain biomarkers in relation to efficacy.
MOA
The lack of immunosuppression is explained by our refined MOA.
All other molecules in development possess varying degrees of
immunosuppression, which give rise to side effects and limit the
dose that can be used to achieve efficacy.
New evidence shows that P140 restores the tolerance systems by
enabling tolerogenic antigen presenting cells (like dendritic
cells) to function properly. As malfunction of the tolerance
systems seems to be the root cause of most if not all autoimmune
diseases, it explains why P140 is so broadly efficient across most
autoimmune indications in animal models. P140 is the only
non-immunosuppressive molecule in the industry in clinical
development for the treatment of SLE.
This distinction sets the stage for a new gold standard therapy,
conveniently self-administered by the patient, once a month, which
is safe and well tolerated unlike standard of care or any other
molecule in development which are all immunosuppressants with
significant safety warnings.
Further details on the protocol and key elements of the clinical
trial design will be communicated, once the details of the trial
are available on clinicaltrials.gov (a comprehensive database of
privately and publicly funded clinical studies conducted around the
world).
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma,
said:
"It has taken longer than we anticipated to fully appraise the
three CROs involved in the tender process, however, we were
determined to ensure that we chose the most effective organisation
that encompassed the high level clinical expertise required to
ensure the highest probability of success for this trial. We are
confident that Simbec-Orion meets our criteria.
Most importantly, following further detailed analysis of the
protocol of this study; new insights into the MOA of P140, combined
with the outstanding safety profile of the drug, we have compelling
evidence that moving directly into a pivotal Phase 3 study, is the
most appropriate route forward and as a result, we have a high
level of confidence of the success of this study.
The second half of this year has been an extremely busy but
focused period for the team and I acknowledge the frustration of
shareholders for the protracted period of time to reach the
decision on the appointment of the CRO. I thank everyone for their
continued patience. We look forward to providing further updates on
the progress of this study, together with progress on CIDP and our
earlier stage programs."
Commenting further, Art Deas, CEO of Avion said:
"We continue to be excited by the potential of P140 and we look
forward to working closely with ImmuPharma and Simbec-Orion, to
develop this potentially life changing treatment for Lupus
patients."
Fabrice Chartier, CEO of Simbec-Orion, further added:
"P140 is one of the most revolutionary and unique new drugs in
development for SLE and we are delighted to have been appointed to
conduct this Phase 3 study."
This announcement contains inside information as stipulated
under the UK version of the Market Abuse Regulation no 596/2014
which is part of English law by virtue of the European (withdrawal)
Act 2018, as amended. On publication of this announcement via a
regulatory information service, this information is considered to
be in the public domain.
For further information please contact:
ImmuPharma PLC ( www.immupharma.com ) +44 (0) 207 206 2650
Tim McCarthy, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge, Bob Pountney +44 (0) 203 650 3650
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical
company that discovers and develops peptide-based therapeutics. The
Company's portfolio includes novel peptide therapeutics for
autoimmune diseases and anti-infectives. The lead program, P140
(Lupuzor(TM)), is a first-in class autophagy immunomodulator for
the treatment of Lupus and preclinical analysis suggest therapeutic
activity for many other autoimmune diseases that share the same
autophagy mechanism of action.
Lupuzor(TM) MOA
The lack immunosuppression is explained by our refined MOA. All
other molecules in development possess varying degrees of
immunosuppression, which give rise to side effects and limit the
dose that can be used to achieve efficacy.
New evidence shows that P140 restores the tolerance systems by
enabling tolerogenic antigen presenting cells (like dendritic
cells) to function properly. As malfunction of the tolerance
systems seems to be the root cause of most if not all autoimmune
diseases, it explains why P140 is so broadly efficient across most
autoimmune indications in animal models. P140 is the only
non-immunosuppressive molecule in the industry in clinical
development for the treatment of SLE.
This distinction sets the stage for a new gold standard therapy,
conveniently self-administered by the patient, once a month, which
is safe and well tolerated unlike standard of care or any other
molecule in development which are all immunosuppressants with
significant safety warnings.
For additional information about ImmuPharma please visit
www.immupharma.co.uk
About Avion Pharmaceuticals LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical
company formed to develop, acquire and market a portfolio of
innovative pharmaceutical products in the Women's Health and other
therapeutic categories aligned with its mission to improve the
quality of patient lives. Avion Pharmaceuticals focuses on
identifying opportunities to develop, acquire and enhance the
market potential of innovative, commercially available therapeutics
and late-stage development drugs to fulfil unmet medical needs.
For more information, visit www.avionrx.com
About Simbec-Orion
Simbec-Orion, is an experienced, full-service Contract Research
Organisation , with offices across the UK, Europe, and the United
States. Established for over 45 years, and leveraging deep
experience delivering first in human clinical trials, providing
bespoke clinical trial services to small to mid-sized biotech and
pharmaceutical partners across Europe, North America and beyond.
Across the organisation scientific teams leverage both a wide
therapeutic experience in clinical pharmacology, such as CNS,
respiratory, dermatology, vaccines and anti-infectives, to more
specialist expertise in Phase I-IV rare disease and oncology .
For more information, visit www.simbecorion.com
About Lupus (Systemic Lupus Erythematosus / SLE)
Lupus is a chronic inflammatory disease which is thought to
affect some 5 million individuals worldwide. The current standard
of care still consists of steroid and anti-malarial therapies which
many have side-effects and poor response in many patients. Recently
more targeted monoclonal therapies are GlaxoSmithKline's Benlysta
and more recently, AstraZeneca's Saphnelo. There still exists a
high unmet medical need for a drug that has a strong efficacy and
safety profile.
ImmuPharma's LEI (Legal Entity Identifier) code :
213800VZKGHXC7VUS895.
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