TIDMIMM
RNS Number : 7510E
Immupharma PLC
10 November 2020
10 November 2020
ImmuPharma PLC
("ImmuPharma" or the "Company")
Update on submission to the FDA for the forthcoming
international Phase 3 trial of Lupuzor(TM) in Lupus patients
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the
specialist drug discovery and development company, announces
further regulatory and operational progress for the new optimised
international Phase 3 trial of Lupuzor(TM) in systemic lupus
erythematosus ("SLE") a potentially life-threatening auto-immune
disease.
Key highlights:
-- The FDA has offered to accept submission for a Type 'A' Meeting Request;
-- Guidance to be sought by Avion on the new Phase 3 clinical trial;
-- FDA also asked to consider a conditional approval of
Lupuzor(TM), whilst Phase 3 trial underway; and
-- Production of new Lupuzor(TM) Phase 3 clinical trial material has been initiated.
Following the notification by ImmuPharma, on 27 July 2020, that
Avion Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for
Lupuzor(TM) had submitted a Special Protocol Assessment ("SPA")
request to the US Food & Drug Administration ("FDA") for the
new optimised international Phase 3 study, the FDA has now
responded.
The FDA offered to accept submission for a Type 'A' Meeting
Request, following which, Avion submitted a full dossier on 6
November 2020 through the FDA Type 'A' route which, in normal
circumstances, leads to a guidance meeting within 30 days. However,
FDA timeframes cannot be guaranteed. The guidance meeting will
address the key aspects of the study design, clinical end points
and approval process.
In addition, Avion has asked the FDA to consider a conditional
approval while the new Phase 3 is underway. A conditional approval,
which would allow the marketing of Lupuzor(TM) prior to the
completion of the new Phase 3, would be based on the clinically
significant data previously generated in the completed Phase 2 and
3 clinical trials to date. Lupuzor(TM) is extremely safe and well
tolerated, and so, whilst the Directors believe that a successful
consideration is only a potential possibility, it allows this to be
asked.
In anticipation of the start of the new Phase 3 clinical trial,
ImmuPharma has initiated the production of a new batch of the
Lupuzor(TM) drug specifically for the trial.
ImmuPharma will provide an update as soon as Avion has met with
the FDA and notified ImmuPharma of the outcome.
Commenting on the announcement, Dimitri Dimitriou, CEO of
ImmuPharma said :
"ImmuPharma and Avion are appreciative of the FDA's fair
treatment of Lupuzor(TM)'s regulatory filing under these
unprecedented times due to the Covid-19 pandemic, which has put
immeasurable pressure on the FDA and the industry as a whole.
"Working closely with the team at Avion we are also encouraged
by their confidence in Lupuzor(TM) illustrated by asking FDA to
consider a conditional approval of Lupuzor(TM) in Lupus patients,
prior to completion of the new Phase 3 clinical trial. Whilst we
accept that a successful consideration is only a potential
possibility, on the basis that Lupuzor(TM) has demonstrated a
robust safety profile, it certainly allows this to be asked. We
look forward to providing further updates in due course."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman + 44 (0) 207 152 4080
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin
Stanford Capital Partners (Joint Broker) +44 (0) 203 36 8 3550
Patrick Claridge
John Howes
Bob Pountney +44 (0) 203 815 8880
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
4Reliance (Euronext Growth Listing Sponsor) +32 (0) 2 747 02 60
Jean-Charles Snoy
Degroof Petercam (Liquidity Provider) +32 (0) 2 287 95 34
Erik De Clippel
Backstage Communication
Olivier Duquaine +32 (0) 477 504 784
Gunther De Backer +32 (0) 475 903 909
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM) is a
specialty biopharmaceutical company that discovers and develops
peptide-based therapeutics. The Company's portfolio includes novel
peptide therapeutics for autoimmune diseases, metabolic diseases,
anti-infectives and cancer. The lead program, Lupuzor(TM), 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. ImmuPharma and Avion Pharmaceuticals
signed on 28 November 2019, an exclusive licence and development
agreement and trademark agreement for Lupuzor(TM) to fund a new
international Phase 3 trial for Lupuzor(TM) and commercialise in
the US.
For additional information about ImmuPharma please visit
www.immupharma.co.uk
ImmuPharma's LEI (Legal Entity Identifier) code:
213800VZKGHXC7VUS895.
About Avion Pharmaceuticals LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical
company formed to develop, acquire and market a portfolio of
innovative pharmaceutical products in the Women's Health and other
therapeutic categories aligned with its mission to improve the
quality of patient lives. Avion Pharmaceuticals focuses on
identifying opportunities to develop, acquire and enhance the
market potential of innovative, commercially available therapeutics
and late-stage development drugs to fulfil unmet medical needs. For
more information, visit www.avionrx.com .
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