REG - Immupharma PLC - UPDATE on P140 (LUPUZOR™) clinical progress

ImmuPharmaAnnouncement

13/04/2022 07:00

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RNS Number : 1814I  Immupharma PLC  13 April 2022

RNS | 13 APRIL 2022

ImmuPharma PLC

("ImmuPharma" or the "Company")

UPDATE on P140 (LUPUZOR™) clinical progress

Data confirms positive readout from P140 PK study

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, is delighted to provide positive data from the Lupuzor™/P140
pharmacokinetic ("PK") study, required by the US Food & Drug
Administration ("FDA"), as part of the new optimised international Phase 3
trial of Lupuzor™ in lupus patients.

 

Key highlights

 

·    Data successfully demonstrates the PK study has met the key endpoints
requested by the FDA

 

·    The dosing of healthy subjects commenced on 15 February 2022
following approval by the Medicines and Healthcare products Regulatory Agency
("MHRA")

 

·    Subcutaneous injection of P140 (in both 200 microgram ("mcg") and 800
mcg doses (note: 1mcg = 1 millionth of a gram) showed a clear time and
dose-related PK profile which is detectable in the blood of human volunteers
and applicable for all potential clinical dosing regimens of P140

 

·    The final group of subjects completed dosing on 30 March 2022. This
was a group of subjects that received an intravenous injection of a 800 mcg
dose of P140, which showed successful measurement of the absolute
bioavailability of the drug (as a control)

 

·    Importantly, and in-line with all human dosing to date, P140 was safe
and well tolerated across all doses and in all subjects

 

·    This positive PK data now clears the path for commencement of all
clinical studies within the P140 platform. In addition to lupus, there is a
planned Phase 2a/3 pivotal trial in chronic inflammatory demyelinating
polyneuropathy ("CIDP")

 

·    Avion Pharmaceuticals, our US partner, has been integral to the
development, initiation and successful conclusion of this PK study. Together,
we are preparing next steps for the progression of the P140 clinical program
and this will be communicated in due course

 

Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:

"We are delighted to be announcing this successful readout of the PK study.
This is a significant milestone for ImmuPharma and for shareholders, and
recognition of the key investment thesis behind ImmuPharma, in respect to
having P140 (Lupuzor™), a late-stage Phase 3 clinical asset for the
treatment of lupus patients with a Phase 2a/3 pivotal trial in CIDP close
behind."

 

Dr Tim Franklin, Chief Operating Officer, added:

"The PK results are highly significant for the progress of the P140 program.
The ImmuPharma Biotech team in Bordeaux also performed predictive modelling in
animals that not only confirmed our confidence to detect P140 in the human PK
study, but also proved, in those models, that P140 continues to work long
after it disappears from the plasma. This strongly supports the unique
autophagy mechanism of action shown by Prof. Sylviane Muller. We would like to
extend our thanks to Prof Muller and our longstanding collaboration partner,
CNRS. We look forward, to working closely with our partner, Avion, on the next
steps towards the Phase 3 study of Lupuzor™ in lupus patients, whilst we
also progress our CIDP clinical program."

 

End

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information is considered to be in the public domain.

 

 For further information please contact:

ImmuPharma PLC (www.immupharma.com (http://www.immupharma.com) )        + 44 (0) 207 206 2650

 Tim McCarthy, Chairman and Chief Executive Officer
 Dr Tim Franklin, Chief Operating Officer
 Lisa Baderoon, Head of Investor Relations & Non-Executive Director      + 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) 20 3650 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, metabolic
diseases, anti-infectives and cancer. The lead program, Lupuzor™, is a
first-in class autophagy immunomodulator which is in Phase 3 for the treatment
of lupus and preclinical analysis suggest therapeutic activity for many other
autoimmune diseases that share the same autophagy mechanism of action.
ImmuPharma and Avion Pharmaceuticals signed on 28 November 2019, an exclusive
licence and development agreement and trademark agreement for Lupuzor™ to
fund a new international Phase 3 trial for Lupuzor™ and commercialise in the
US.

 

For additional information about ImmuPharma please visit
www.immupharma.co.uk

 

ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.

 

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
drugs which have many side-effects and limited efficacy. Despite the need for
an effective treatment, only two therapies, namely GlaxoSmithKline's Benlysta
and more recently, Astra Zeneca's Saphnelo, have been approved to treat the
condition over the past 50 years. As such, there clearly exists an unmet
medical need for a drug that has a strong efficacy and safety profile.

About MHRA
The Medicines and Healthcare products Regulatory Agency ("MHRA") is an
executive agency of the Department of Health and Social Care in the United
Kingdom which is responsible for ensuring that medicines and medical devices
work and are acceptably safe. For more information go to:
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
(https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)

 

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