TIDMIMM
RNS Number : 1814I
Immupharma PLC
13 April 2022
RNS | 13 APRIL 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
UPDATE on P140 (LUPUZOR(TM)) 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(TM)/P140 pharmacokinetic ("PK") study, required by the US
Food & Drug Administration ("FDA"), as part of the new
optimised international Phase 3 trial of Lupuzor(TM) 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(TM)), 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(TM) in lupus patients, whilst we also progress our
CIDP clinical program."
End
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.
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman and Chief Executive
Officer + 44 (0) 207 206 2650
Dr Tim Franklin, Chief Operating Officer
Lisa Baderoon, Head of Investor Relations
& Non-Executive Director + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge +44 ( 0) 20 3650 3650
John Howes
Bob Pountney
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, metabolic diseases, anti-infectives and
cancer. The lead program, Lupuzor(TM), 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(TM) to fund a new international
Phase 3 trial for Lupuzor(TM) 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
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