Positive Pre-IND meeting with FDA

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) Tim McCarthy, Chief Executive Officer Lisa Baderoon, Head of Investor Relations [phone] + 44 (0) 7721 413496 SPARK Advisory Partners Limited (NOMAD) Neil Baldwin Stanford Capital Partners (Joint Broker) Patrick Claridge, John Howes, Bob Pountney SI Capital (Joint Broker) Nick Emerson [phone] [phone] [phone]

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.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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