TIDMIMM
RNS Number : 2290U
Immupharma PLC
27 March 2023
27 March 2023
ImmuPharma PLC
("ImmuPharma" or the "Company")
Avion submits clinical protocol of Phase 2/3 adaptive study of
Lupuzor(TM) in lupus to FDA
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is delighted to update the market on the next
positive step in its Lupuzor(TM) (P140) program in patients with
systemic lupus erythematosus ("SLE/Lupus"). This follows on from
the recent announcement on 6 February 2023.
Key highlights:
-- Avion Pharmaceuticals ("Avion") and ImmuPharma agreed in
February on a Phase 2/3 adaptive trial design for the next clinical
study of Lupuzor(TM) in Lupus patients.
-- A Phase 2/3 clinical trial protocol has now been submitted to
the Food and Drug Administration ("FDA"). This new design takes
into account the FDA's key guidance points from the previous Type-C
meeting in addition to insights from the pharmacokinetic ("PK")
study completed last year.
-- The submitted protocol contains many changes from the design
of the previous Phase 3 clinical trial carried out by ImmuPharma.
The most significant and important changes concern the level of
dose being administered and the method of administration.
-- A Type C meeting with the FDA has been requested and the date
of the meeting should be confirmed within the FDA guidelines of 21
days from submission which is expected to be within the FDA
guidelines of 75 days from submission. We will update the market
with the date of the meeting once confirmed by FDA.
-- The Phase 2/3 study remains on track to commence in H2 2023.
On 6 February 2023, ImmuPharma confirmed that they had agreed
with Avion on an adaptive Phase 2/3 study for Lupuzor(TM) in SLE
patients. For background, this is a one-protocol pivotal study
which allows exploration of a dose-range in the Phase 2 part of the
study, followed by seamless progression into the Phase 3 part of
the study at the chosen dose. The overall timelines are much
shorter than carrying out two separate protocols (i.e. Phase 2
followed by Phase 3). It is also expected to be less costly
overall.
This new study design incorporates guidance from the FDA which
advised exploration of higher dose levels than have been used in
the clinical program to date, and insights gained from data
generated from the PK study completed last year.
Consequently, it is expected that the Phase 2 part of the new
clinical trial will identify a multiple times higher dose level to
be used in the Phase 3 part compared to the 200mcg dose given to
patients in the previous Phase 3 clinical trial carried out by
ImmuPharma. Also it is proposed that the method of administration
will be changed from a subcutaneous injection to an intravenous
injection, so ensuring that significantly higher blood levels of
Lupuzor(TM) (P140) can be achieved, thereby greatly increasing the
probability of a significant efficacy result in patients.
Importantly, a clean safety profile of Lupuzor(TM) has already
been established at the higher doses to be examined in the Phase 2
part, thereby preserving the Target Product Profile of Lupuzor(TM)
which is to be significantly efficacious for patients with no
serious side effects.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma,
said:
"We are extremely pleased to be moving positively forward with
the Lupuzor(TM) program. Avion and ourselves believe that the new
design of the Phase 2/3 adaptive study offers the greatest
probability of a successful result for the overall benefit of Lupus
patients. We remain on track to commence the trial in H2 2023."
Commenting further, Art Deas, CEO of Avion said:
"We remain committed to our full support of ImmuPharma, and with
insights gained from last year's PK study and invaluable guidance
from the FDA, we believe we have submitted the most robust clinical
protocol for Lupuzor(TM)."
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 ) +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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