REG - Immupharma PLC - Lupuzor Update

ImmuPharmaAnnouncement

30/09/2022 07:30

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RNS Number : 2629B  Immupharma PLC  30 September 2022

 
30 September 2022

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

Lupuzor™ Update

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, provides an update on Lupuzor™, following the Company's recent
announcement on 14 September 2022, that its US partner for Lupuzor™ (P140),
Avion Pharmaceuticals ("Avion"), had received a written response from the Food
and Drug Administration ("FDA") to the Type C meeting.

 

In summary, the FDA response earlier this month, recommended assessing the
potential to use higher dosing in the next clinical program of  Lupuzor™ in
Lupus, to optimise the clinical benefit to Lupus patients and to maximise
efficacy. In addition, the FDA made additional recommendations on clinical
measurements, again to support Lupuzor™ through the regulatory process to
approval.

 

Since then, both ImmuPharma and Avion, with their clinical and regulatory
teams and advisors, have been reviewing in detail the FDA's written response
and recommendations.

 

Further details on the next steps for Lupuzor™ will be communicated to the
market, once finalised between ImmuPharma and Avion.

 

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

 

"Following receipt of the FDA letter earlier this month, we welcome the
 helpful recommendations from the FDA on the next steps in the Lupuzor™
clinical program. We equally recognise shareholders' frustrations on what
is a very complex regulatory process, which is having an impact on
moving Lupuzor™ forward. However, we are working very closely with the
clinical and regulatory teams at Avion to accommodate the FDA's
recommendations and decide on the next steps. We will update the market as
soon as we have further guidance to share."

 

 

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

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

 SPARK Advisory Partners Limited (NOMAD)

 Neil Baldwin

                                                                   +44 (0) 20 3650 3650

 Stanford Capital Partners (Joint Broker)

 Patrick Claridge, John Howes, Bob Pountney

                                                                   +44 (0) 1483 413500

 SI Capital (Joint Broker)

 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 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.

 

 

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