Immupharma PLC UPDATE on LUPUZOR(TM) PROGRESS to PHASE 3 with AVION (1693K)
04 May 2022 - 4:00PM
UK Regulatory
TIDMIMM
RNS Number : 1693K
Immupharma PLC
04 May 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
UPDATE on LUPUZOR(TM) - POSITIVE PROGRESS to PHASE 3 with
AVION
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is delighted to confirm that final
preparations are now underway to progress Lupuzor(TM) into its new
optimised international Phase 3 trial of Lupuzor(TM) in lupus
patients.
Further to the recent positive results from the Lupuzor(TM)/P140
Pharmacokinetic ("PK") study announced on 13 April 2022, we are
pleased to announce that Avion Pharmaceuticals ("Avion"), our US
partner, has confirmed to us, that they are now requesting final
guidance from the US Food & Drug Administration ("FDA"), in
order to commence the Lupuzor(TM) Phase 3 trial.
As we reported, the PK study required by the FDA, demonstrated
that the key endpoints had been met and in-line with all human
dosing to date, that P140 was safe and well tolerated across all
doses and in all subjects.
Commenting on the announcement, Tim McCarthy, Chief Executive
Officer, said:
" We are delighted to be announcing positive progress towards
the commencement of the new optimised international Phase 3 trial
of Lupuzor(TM) in lupus patients. Following the positive readout
from the PK study, we have been working closely with the team at
Avion to move Lupuzor(TM) as quickly as possible to the start of
the Phase 3 trial."
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.
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