REG - Immupharma PLC - Positive Pre-IND meeting with FDA

ImmuPharmaAnnouncement

18/05/2023 07:00

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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™) 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™) 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™) 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)      +44 (0) 203 368 3550 (about:blank)

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)     +44 (0) 203 650 3650

 Patrick Claridge, John Howes, Bob Pountney

 SI Capital (Joint Broker)                    +44 (0) 1483 413500

 Nick Emerson

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™), 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
(http://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® (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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