Immupharma PLC Confirmed FDA response date for Type C Meeting (6038R)
July 07 2022 - 2:00AM
UK Regulatory
TIDMIMM
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(TM) (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(TM) 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(TM) 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 )
Tim McCarthy, Chairman and Chief Executive
Officer +44 (0) 207 206 2650
Dr Tim Franklin, Chief Operating Officer
Lisa Baderoon, Head of Investor Relations
& Non-Executive Director + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes, Bob Pountney +44 (0) 20 3650 3650
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
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(TM), 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(TM) is being
funded by Avion, who have the exclusive rights to commercialise
Lupuzor(TM) 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(TM) 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.
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