REG - Immupharma PLC - Update on Lupuzor

ImmuPharmaAnnouncement

27/06/2022 07:00

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RNS Number : 2084Q  Immupharma PLC  27 June 2022

 

RNS:
RELEASE
27 JUNE 2022

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

Avion seeks final regulatory guidance as it prepares for the start of the
international Phase 3 trial of Lupuzor™ in Lupus patients

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, is delighted to announce that, having met all the Food and Drug
Administration's ("FDA") requirements, Avion Pharmaceuticals ("Avion"), its US
partner, has confirmed that it has sought final regulatory guidance from the
FDA, as it actively prepares for the start of the international Phase 3 trial
of Lupuzor™ in Lupus patients.

 

This confirmation follows a recent meeting between the two companies at
Avion's US headquarters in Atlanta, Georgia.

 

Further to our last update  on 4(th) May 2022, Avion has submitted, via a
Type C Meeting, the positive results from the Lupuzor™/P140 Pharmacokinetic
("PK") study to the FDA.

 

As noted in previous announcements, the PK study required by the FDA, met all
the key endpoints and (in line with all human dosing to date), demonstrated
that P140 was safe and well tolerated across all doses and in all subjects.

 

As previously disclosed, as an integral part of the licence and development
agreement for Lupuzor™ entered into between Avion and ImmuPharma, the new
international Phase 3 trial for Lupuzor™ is being funded by Avion, who have
the exclusive rights to commercialise Lupuzor™ in the US, whilst the rest of
the world rights remain with ImmuPharma.

 

Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:
"This final step by Avion is a pivotal moment for the Company and for the
progress of Lupuzor™ towards becoming a groundbreaking new treatment for
Lupus patients.  Lupuzor's™ unique mechanism of action and robust safety
profile will, we believe, position Lupuzor™ as a first line therapy to many
Lupus sufferers globally."

 

Art Deas, Chief Executive Officer of Avion further commented: "Having met all
the FDA's requirements, we are delighted to be seeking the FDA's final
guidance on moving Lupuzor™ forward into the new international Phase 3
trial. We anticipate Lupuzor™ becoming the leading product in our portfolio
and that it will be instrumental in bringing an innovative treatment to Lupus
patients, which is not currently available on the market today."

 

 

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, 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 (about%3Ablank)

 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 and
anti-infectives. 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.

 

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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