REG - Immupharma PLC - Lupuzor™ Update

ImmuPharmaAnnouncement

06/02/2023 07:00

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RNS Number : 9419O  Immupharma PLC  06 February 2023

 
6 February 2023

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

Lupuzor™ Update

Phase 2/3 adaptive study design for Lupus study agreed with Avion

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, provides an update to the market on its Lupuzor™ programme in
patients with systemic lupus erythematosus ("SLE")

 

Key highlights:

 

·    In conjunction with its partner Avion Pharmaceuticals ("Avion"),
ImmuPharma confirms that a Phase 2/3 adaptive trial will be the best design
for the next clinical study of Lupuzor™ in SLE patients

·    The study is targeted to commence in H2 2023 following submission
through the FDA/PDUFA* process

 

ImmuPharma confirms that with its partner Avion, they have agreed on an
adaptive Phase 2/3 study for Lupuzor™ in SLE patients. 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 for the lupus
clinical program are faster as one avoids the need for stopping and starting
two independent trials, regulatory checks, ethics approvals and site
set-ups.  It is also expected to be less costly overall. There is also an
opportunity, through an interim analysis in the Phase 3 part of the study, to
stop the study earlier if an efficacy signal is reached after a certain
percentage of patients have been treated.

 

This new study design incorporates guidance from the Food and Drug
Administration ("FDA") which advised exploration of higher dose levels than
have been used in the clinical program to date. A clean safety profile has
already been established at higher doses. The ImmuPharma/Avion team, together
with external advisors, are now preparing an updated clinical protocol.

 

 

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

 

"We have had extremely productive discussions with Avion over the last few
weeks on the Lupuzor™ programme and we have agreed that the optimum way
forward for Lupuzor™ is to undertake an adaptive Phase 2/3 trial.  Our key
focus will be to commence the trial during H2 2023."

 

 

 

 

 

 

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

*FDA | Food and Drug Administration

* PDUFA |  Prescription Drug User Fee Act

 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.

 

About PDUFA

 

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United
States Congress (https://en.wikipedia.org/wiki/United_States_Congress)  in
1992 which allowed the Food and Drug Administration
(https://en.wikipedia.org/wiki/Food_and_Drug_Administration)  (FDA) to
collect fees from drug manufacturers
(https://en.wikipedia.org/wiki/Pharmaceutical_company)  to fund the new drug
(https://en.wikipedia.org/wiki/Medication)  approval process. The Act
provided that the FDA was entitled to collect a substantial application fee
from drug manufacturers at the time a New Drug Application
(https://en.wikipedia.org/wiki/New_Drug_Application) (NDA) or Biologics
License Application
(https://en.wikipedia.org/wiki/Biologics_License_Application)  (BLA) was
submitted, with those funds designated for use only in Center for Drug
Evaluation and Research
(https://en.wikipedia.org/wiki/Center_for_Drug_Evaluation_and_Research)
 (CDER) or Center for Biologics Evaluation and Research
(https://en.wikipedia.org/wiki/Center_for_Biologics_Evaluation_and_Research)
 (CBER) drug approval activities. In order to continue collecting such fees,
the FDA is required to meet certain performance benchmarks, primarily related
to the speed of certain activities within the NDA review process.

 

 

ImmuPharma's LEI (Legal Entity Identifier) code : 213800VZKGHXC7VUS895.

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