TIDMIMM
RNS Number : 8829V
Immupharma PLC
12 April 2023
12 April 2023
ImmuPharma PLC
("ImmuPharma" or the "Company")
ImmuPharma receives confirmation of pre-IND meeting date with
FDA for a Phase 2/3 adaptive study 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 P140 clinical program in patients with
chronic idiopathic demyelinating polyneuropathy ("CIDP").
Key highlights:
-- ImmuPharma has received confirmation from the Food and Drug Administration ("FDA") for a pre- Investigational New Drug meeting date of 16 May 2023 to consider a Phase 2/3 adaptive trial study protocol for P140 in CIDP
-- This will be the first pivotal stage clinical study of P140
in patients with CIDP: a rare neurological disease with high
medical need
-- A new Investigational New Drug ("IND") submission is
required, as this will be the first time that P140 is to be studied
in humans for the indication of CIDP
-- An application for Orphan Drug status will be submitted following the pre-IND meeting
-- The CIDP market is expected to reach global sales of US$2.7bn by 2029*
In a significant new positive step forward in its P140 platform,
ImmuPharma has received confirmation from the FDA of a meeting date
of 16 May 2023 for a pre-IND meeting to consider a Phase 2/3
adaptive trial study protocol for CIDP.
This will be the first pivotal stage clinical 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.
A new IND submission is required for CIDP, as this will be the
first time that P140 is to be studied in humans for the indication
of CIDP. Once ImmuPharma has received the feedback from this
pre-IND guidance meeting, a request will be made to FDA for a
meeting date for submission of the study protocol, at a Type-B IND
meeting.
An application for Orphan Drug status will be submitted
following the pre-IND meeting. If approved, this will provide 7
years' market exclusivity post-marketing approval. Acceptance for
Orphan Drug status is expected in H2 2023. The CIDP protocol is
founded on much of the preclinical and clinical work carried out to
date on P140 (Lupuzor(TM)) in Lupus, which itself is scheduled to
begin a Phase 2/3 adaptive study in Lupus patients in H2 2023.
* Source: Data Bridge Market Research, Dec 2022
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma,
said:
"We are delighted to be moving P140 into its second indication
for CIDP patients who suffer from a rare disease with high unmet
medical need. This is a great example of P140's broad potential.
Like many autoimmune and inflammatory conditions such as lupus,
CIDP is caused by a similar biological mechanism. P140's unique
mechanism of action selectively corrects these, making it a
promising treatment option across a range of indications".
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 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.
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 the majority of
lupus patients due to its excellent safety profile to date and
convenient administration. To date there are two indications for
P140 due to start phase2/3 adaptive 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.
ImmuPharma's LEI (Legal Entity Identifier) code :
213800VZKGHXC7VUS895.
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