REG - Immupharma PLC - Confirmed FDA response date for Type C Meeting

ImmuPharmaAnnouncement

07/07/2022 07:16

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220707:nRSG6038Ra&default-theme=true

RNS Number : 6038R  Immupharma PLC  07 July 2022

 

 
07 July 2022

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

 

FDA confirms response date for Type C Meeting as 29(th) August 2022

 

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development
company, is delighted to announce that its US partner for Lupuzor™ (P140),
Avion Pharmaceuticals ("Avion"), has advised that it has now received Type C
Meeting confirmation from the Food and Drug Administration ("FDA").

 

The statement of purpose, objectives, and proposed agenda of the Type C
meeting have been agreed with the FDA. The FDA also agree that written
responses to the agenda items would be the most appropriate means for
responding and that a face to face meeting is not required. The agreed date
from the FDA for providing its written responses is 29 August 2022.

 

As per our announcement of 27 June 2022, Avion recently requested a Type C
Meeting, primarily to report the data on the successfully completed P140
pharmacokinetic ("PK") study. In addition, Avion has taken the opportunity to
ask questions related to the use of P140. This aims to strengthen the future
product label and secure advantageous differentiation of P140 for use in Lupus
patients.

 

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, P140 was safe and
well tolerated across all doses and in all subjects.

 

As reported from the previous phase 3 trial, patients who were biomarker
positive (anti-ds DNA antibody positive) responded better to Lupuzor™ than
those who were biomarker negative. However, in the previous study patients
were not screened and selected on the basis of biomarker positivity prior to
randomisation. The biomarker will act as a very useful "theragnostic" to
ensure that Lupus patients who show this biomarker have the best opportunity
to receive the maximum benefit  from Lupuzor™ therapy. The new
international Phase 3 clinical trial protocol requires the presence of the
biomarker before being allowed into the study. This protocol was accepted by
the FDA at the previous Type C meeting in 2021.

 

 

Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:
"We applaud the quick turnaround from the FDA in respect to Avion's request
for this Type C Meeting and pleased to note the FDA's confirmation that only a
written response is required and no face to face meeting is needed."

 

 

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 for the treatment of Lupus and preclinical analysis suggest
therapeutic activity for many other autoimmune diseases that share the same
autophagy mechanism of action.

 

The new international Phase 3 trial for Lupuzor™ is being funded by Avion,
who have the exclusive rights to commercialise Lupuzor™ in the US. The rest
of the world rights remain with ImmuPharma and partnering discussions will be
an integral part of creating further opportunities for Lupuzor™ in Lupus and
the P140 platform across several additional indication targets going forward.
The next indication being Chronic inflammatory demyelinating
polyneuropathy (CIDP)

 

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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCRFMBTMTMMTFT