TIDMIMM
RNS Number : 8612Z
Immupharma PLC
18 May 2023
18 May 2023
ImmuPharma PLC
("ImmuPharma" or the "Company")
Positive guidance from the FDA Pre-IND meeting supports an IND
application and a Phase 2/3 adaptive clinical trial of P140 in
CIDP
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to announce further positive
progress in its late-stage clinical program in patients with
chronic idiopathic demyelinating polyneuropathy ("CIDP"), which is
a further debilitating auto-immune condition within the Company's
P140 platform
Key highlights:
-- ImmuPharma has received positive support and guidance from
the Food and Drug Administration ("FDA"), following the
Pre-Investigational New Drug ("PIND") meeting that confirms the
route for a Phase 2/3 adaptive clinical study of P140 in CIDP
-- The FDA feedback recognises that P140 is suitable to be
studied in another disease indication in addition to SLE (systemic
lupus erythematosus) and this strongly supports the underlying
science and mechanism of action of P140 across several
auto-immune/inflammatory diseases and is a significant breakthrough
for the P140 platform
-- The Phase 2/3 adaptive clinical trial will be the first
pivotal stage study of P140 in patients with CIDP: a rare
neurological disease with high medical need
-- An IND application will now be prepared for submission to the
FDA, incorporating all guidance points and pending approval, we
remain on track to commence* the Phase 2/3 adaptive clinical trial
in H2 2023
-- An application for Orphan Drug status for CIDP will be also
submitted in parallel to the full IND application
-- The CIDP market is expected to reach global sales of US$2.7bn by 2029
This feedback from the FDA provides not only positive support
and guidance for an IND application and acceptance of the Phase 2/3
clinical trial design for CIDP, but also recognises the potential
therapeutic benefit in another auto-immune/inflammatory disease in
addition to P140 (Lupuzor(TM)) in SLE, representing a significant
breakthrough for the P140 platform.
The Phase 2/3 clinical trial will be the first pivotal stage
study of P140 in patients with CIDP: a rare neurological disease
with high medical need. The study design was developed with our
contract research organisation (CRO) and CIDP opinion leaders from
Europe and the USA.
The CIDP protocol is founded on much of the preclinical and
clinical work carried out to date on P140 (Lupuzor(TM)) in SLE,
which itself is scheduled to begin a Phase 2/3 adaptive clinical
trial in Lupus patients in H2 2023. Many elements of the FDA
guidance for CIDP, particularly the Phase 2/3 protocol design and
dosing, can now be anticipated for the upcoming FDA Type-C meeting
for P140 (Lupuzor(TM)) in SLE on or around the 7(th) June 2023.
An application for Orphan Drug status will be submitted, in
parallel to the IND application Acceptance for Orphan Drug status
this year will provide 7 years' market exclusivity post-marketing
approval.
The CIDP market is expected to reach global sales of US$2.7bn by
2029.
*Commencement is defined as the CRO is chosen, trial sites are
being confirmed and set-up and regulatory and ethics committee
submissions are progressing.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma,
said:
" We are delighted to have received this positive support and
guidance from the FDA on our pre-IND application for CIDP. As we
now move forward to a full IND application this program remains on
track to commence its Phase 2/3 adaptive clinical trial in H2 2023.
Furthermore, as our P140 technology platform provides the basis for
both our Lupus and CIDP programs, we look forward to also
commencing the Lupus Phase 2/3 clinical trial in H2 2023 ".
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.
Ends
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, John Howes, 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.
For additional information about ImmuPharma please visit
www.immupharma .co.uk
About the P140 Platform
Many autoimmune/inflammatory diseases involve overactive immune
cells or specifically T-cells. P140's unique mechanism of action
(MOA) involves modulating the activation of auto-reactive T-cells
and "normalising" their overactivity rather than over-suppressing
them. It is unlike other therapies which may cause too much
immunosuppression in some patients. P140 is first-in its class and
holds the potential as a first-line therapy in a large majority of
lupus patients due to its excellent safety profile to date and
convenient administration. To date there are two indications for
P140 scheduled to start phase2/3 adaptive clinical trials in H2
2023; Lupuzor(TM) (the trade name for P140) in lupus and P140 in
CIDP.
The unique MOA of P140 has also been linked to other diseases
and this has been confirmed in pre-clinical animal models. This
provides scope to explore the potential of P140 in the future in
asthma, irritable bowel disease, periodontitis, and gout.
About Chronic Idiopathic Demyelinating Polyneuropathy
("CIDP")
CIDP is a rare acquired autoimmune disorder of peripheral nerve
affecting approximately 50,000 individuals across the USA/Europe.
It is described by the National Institute of Neurological Disorders
and Stroke (NINDS) as a neurological disorder characterized by
progressive weakness and impaired sensory function in the legs and
arms. The European Academy of Neurology/ Peripheral Nerve Society
(EAN/PNS) diagnosis guideline notes that CIDP is the most common
immune-mediated neuropathy. CIDP can occur in both genders at any
age, it is more common in young men than women. The initial
generally symptoms are tingling or numbness (beginning in the toes
and fingers), weakness of the arms and legs, loss of deep tendon
reflexes (areflexia), fatigue, and abnormal sensations. CIDP is
closely related to Guillain-Barre syndrome, and it is considered
the chronic counterpart of that acute disease.
Complications of CIDP include permanent decrease or loss of
sensation in areas of the body and permanent weakness or paralysis
in areas of the body. These symptoms may result in impaired lower
and upper limb function. For many patients the burden of treatment
(side effects, cost, time, loss of autonomy) can be
substantial.
In the United States, intravenous immunoglobulin (IVIG) is
considered first line treatment. Multiple IVIG products including
Panziga(R) (Pfizer), Gamunex (Grifols) and Privigen (CSL Behring)
have been approved for treatment of adults with CIDP to improve
neuromuscular disability and impairment. The mechanism by which
IVIG improves CIDP is not clearly understood, but likely involves
competing with or removing pathogenic autoantibodies, thereby
preventing myelin and axonal injury. Within a setting void of
inflammatory nerve attack, nerves may auto-heal and their function
can be restored. In cases where nerve injury is severe or very
chronic repair is an unrealistic objective, and the focus turns to
preventing the disease from getting worse. Other than IVIG,
corticosteroids and plasma exchange are evidence-based proven
effective CIDP treatment options.
About the Pre-IND and IND
A pre-IND (pre-Investigational new drug) meeting is a drug
sponsor's first formal meeting with the FDA as they begin the
process of bringing a drug to market for a new disease indication.
Following guidance from the FDA at the pre-IND meeting an IND is a
request from a clinical study sponsor to obtain authorization from
the FDA to administer an investigational drug or biological product
to humans.
ImmuPharma's LEI (Legal Entity Identifier) code :
213800VZKGHXC7VUS895.
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