REG - Immupharma PLC - Written Response received from the FDA

ImmuPharmaAnnouncement

14/09/2022 10:15

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RNS Number : 4375Z  Immupharma PLC  14 September 2022

 

 
14 September 2022

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

Written Response received from the FDA

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, announces that, further to the Company's notification of 7 July 2022,
its US partner for Lupuzor™ (P140), Avion Pharmaceuticals ("Avion"), has
received a written response from the Food and Drug Administration ("FDA") to
the Type C meeting.

 

The FDA response was detailed and included significant guidance on next steps
for the clinical programme. This included advice on the dosing regime. In
addition, the FDA also provided further significant guidance on the study
protocol that can be amended to improve the regulatory outcome.

 

The Company is currently reviewing the written response with Avion and will
make a further notification in due course.

 

 

 

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

 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 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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