Immupharma PLC Lupuzor Update (0745D)
19 Juni 2023 - 8:00AM
UK Regulatory
TIDMIMM
RNS Number : 0745D
Immupharma PLC
19 June 2023
19 June 2023
ImmuPharma PLC
("ImmuPharma" or the "Company")
Phase 2/3 adaptive clinical trial of P140 (Lupuzor(TM)) in Lupus
to commence following FDA meeting
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to announce that the Phase 2/3
adaptive clinical trial of P140 (Lupuzor(TM)) in patients with
systemic lupus erythematosus ("SLE/Lupus") is to commence in H2
2023.
Key highlights:
-- Following the receipt of comprehensive guidance from the Food
and Drug Administration ("FDA") in 3 separate Type-C meetings, a
Phase 2/3 adaptive clinical trial of P140 (Lupuzor(TM)) in patients
with Lupus will commence in H2 2023.
-- Avion Pharmaceuticals ("Avion") have confirmed that under the
previously announced terms of the existing Licence Agreement, they
will continue to support the new clinical trial design and Avion
and ImmuPharma have agreed to proceed and will now begin
preparatory steps for the Phase 2/3 adaptive clinical trial.
-- The trial design and protocol is substantially different from
previous clinical trials that ImmuPharma has completed and includes
maintaining subcutaneous dosing but at much higher concentrations
and significant changes to patient inclusion criteria and primary
and secondary clinical endpoints.
The detailed protocol and key elements of the clinical trial
design will be communicated at a later stage once the details of
the trial are available on clinicaltrials.gov (a comprehensive
database of privately and publicly funded clinical studies
conducted around the world).
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma,
said:
"We are delighted to be moving forward with the study for P140
(Lupuzor(TM)) in Lupus after receiving comprehensive guidance from
the FDA on the protocol . Avion and ourselves are confident in the
new design of the Phase 2/3 adaptive clinical trial and in
ultimately delivering a new efficacious and safe therapy for Lupus
patients."
Commenting further, Art Deas, CEO of Avion said:
"The FDA has provided us with comprehensive guidance to commence
the Phase 2/3 adaptive clinical trial for P140 (Lupuzor(TM)) and we
look forward to continue working closely with ImmuPharma to deliver
a successful result for Lupus patients."
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 ) +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)
Neil Baldwin +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes, Bob Pountney +44 (0) 203 650 3650
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 and anti-infectives. The lead program, P140
(Lupuzor(TM)), 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 Avion Pharmaceuticals LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical
company formed to develop, acquire and market a portfolio of
innovative pharmaceutical products in the Women's Health and other
therapeutic categories aligned with its mission to improve the
quality of patient lives. Avion Pharmaceuticals focuses on
identifying opportunities to develop, acquire and enhance the
market potential of innovative, commercially available therapeutics
and late-stage development drugs to fulfil unmet medical needs.
For more information, visit www.avionrx.com .
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 steroid and anti-malarial therapies which
many have side-effects and poor response in many patients. Recently
more targeted monoclonal therapies are GlaxoSmithKline's Benlysta
and more recently, AstraZeneca's Saphnelo. There still exists a
high unmet medical need for a drug that has a strong efficacy and
safety profile.
ImmuPharma's LEI (Legal Entity Identifier) code :
213800VZKGHXC7VUS895.
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