REG - Immupharma PLC - Lupozor Update - FDA confirms Type-C meeting date

ImmuPharmaAnnouncement

19/04/2023 07:00

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RNS Number : 7231W  Immupharma PLC  19 April 2023

 
19(th) April 2023

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

FDA confirms Type-C meeting date of 7th June 2023

for Phase 2/3 adaptive study of Lupuzor™ in lupus

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, is pleased to announce that  the Food and Drug Administration
("FDA") has set a date of 7(th) June 2023 for a Type-C meeting to provide
guidance on the  Phase 2/3 adaptive study of Lupuzor™ ("P140") in patients
with systemic lupus erythematosus ("SLE/Lupus"). This follows on from the
recent announcement on 27 March 2023.

 

Avion (our US partner) has provided the FDA with a full package of documents
and information which addresses all the key guidance points from the previous
Type-C meeting, particularly concerning dosing. The FDA guidance is in
addition to the clinical pharmacokinetic ("PK") study completed last year
which provided, amongst other observations, a critical insight into the
relevant dose range and method of administration of Lupuzor™ (P140). This
Phase 2/3 study remains on track to commence in H2 2023.

 

Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma, said:

 

"Following on from our announcement last week of the pre-IND meeting with the
FDA on P140 in CIDP, we are delighted to confirm this meeting date with the
FDA on P140 in lupus. With the prospect of both of these indications moving
positively forward into pivotal studies in H2 2023 there is real value
momentum building in our P140 franchise"

 

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 (http://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)                           +44 (0) 203 368 3550 (about%3Ablank)

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                          +44 (0) 203 650 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 and
anti-infectives. The lead program, P140 (Lupuzor™), 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
(http://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 (https://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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