REG - Immupharma PLC - UPDATE on LUPUZOR™ PROGRESS to PHASE 3 with AVION

ImmuPharmaAnnouncement

04/05/2022 07:00

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RNS Number : 1693K  Immupharma PLC  04 May 2022

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

UPDATE on LUPUZOR™ - POSITIVE PROGRESS to PHASE 3 with AVION

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, is delighted to confirm that final preparations are now underway to
progress Lupuzor™ into its new optimised international Phase 3 trial of
Lupuzor™ in lupus patients.

 

Further to the recent positive results from the Lupuzor™/P140
Pharmacokinetic ("PK") study announced on 13 April 2022, we are pleased to
announce that Avion Pharmaceuticals ("Avion"), our US partner, has confirmed
to us, that they are now requesting final guidance from the US Food & Drug
Administration ("FDA"), in order to commence the Lupuzor™ Phase 3 trial.

 

As we reported, the PK study required by the FDA, demonstrated that the key
endpoints had been met and in-line with all human dosing to date, that P140
was safe and well tolerated across all doses and in all subjects.

 

Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:

"We are delighted to be announcing positive progress towards the commencement
of the new optimised international Phase 3 trial of Lupuzor™ in lupus
patients. Following the positive readout from the PK study, we have been
working closely with the team at Avion to move Lupuzor™ as quickly as
possible to the start of the Phase 3 trial."

 

End

This announcement contains inside information as stipulated under the UK
version of the Market Abuse Regulation no 596/2014 which is part of English
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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, Chairman and Chief Executive Officer
 Dr Tim Franklin, Chief Operating Officer
 Lisa Baderoon, Head of Investor Relations & Non-Executive Director      + 44 (0) 7721 413496

 SPARK Advisory Partners Limited (NOMAD)                                 +44 (0) 203 368 3550

 Neil Baldwin

 Stanford Capital Partners (Joint Broker)                                +44 (0) 20 3650 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, metabolic
diseases, anti-infectives and cancer. The lead program, Lupuzor™, is a
first-in class autophagy immunomodulator which is in Phase 3 for the treatment
of lupus and preclinical analysis suggest therapeutic activity for many other
autoimmune diseases that share the same autophagy mechanism of action.
ImmuPharma and Avion Pharmaceuticals signed on 28 November 2019, an exclusive
licence and development agreement and trademark agreement for Lupuzor™ to
fund a new international Phase 3 trial for Lupuzor™ and commercialise in the
US.

 

For additional information about ImmuPharma please visit
www.immupharma.co.uk

 

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

 

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
drugs which have many side-effects and limited efficacy. Despite the need for
an effective treatment, only two therapies, namely GlaxoSmithKline's Benlysta
and more recently, Astra Zeneca's Saphnelo, have been approved to treat the
condition over the past 50 years. As such, there clearly exists an unmet
medical need for a drug that has a strong efficacy and safety profile.

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