REG - Immupharma PLC - Lupuzor Update

ImmuPharmaAnnouncement

19/06/2023 07:00

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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™) 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™) 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™) 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™) 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™) 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 (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:blank)

 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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