TIDMIMM
RNS Number : 8094A
Immupharma PLC
07 February 2022
RNS | 7 FEBRUARY 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
LUPUZOR(TM) UPDATE
PK study commencement approved by MHRA - patient dosing to
commence imminently
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is delighted to provide an update on the
Lupuzor(TM) pharmacokinetic ("PK") study, as part of the new
optimised international Phase 3 trial of Lupuzor(TM) in Lupus
patients.
Key highlights
-- Medical and Health Products Regulatory Agency ("MHRA") approves commencement of the PK study
-- Volunteers have been selected and approved for inclusion in the PK study
-- Volunteer dosing to commence on 15 February 2022
-- Study on track to deliver results around the end Q1 2022
Following the approval from the US Food & Drug
Administration ("FDA") of the protocol for the pharmacokinetic
("PK") study and local Ethics committee approval, ImmuPharma has
been working with Avion Pharmaceuticals ("Avion"), our exclusive US
partner, and our Contract Research Organisation ("CRO"),
Simbec-Orion, together with additional specialist service
providers, to prepare the commencement of the study.
As part of the regulatory process, the Investigational Medicinal
Product Dossier ("IMPD") required significant revision, due to the
inclusion of a new proprietary synthesis of P140, which
consequently affords greater IP protection and lower cost of goods.
The new IMPD was submitted to the MHRA and, following a full
review, the MHRA has approved the commencement of the PK study.
The PK study is a Phase I study to assess the presence of
Lupuzor(TM) in the body after administration of a single dose. The
study will be carried out in a total of up to 24 healthy male
volunteers.
Volunteers have been selected and approved with dosing to
commence on 15 February 2022. As previously advised, we expect
study results to be available around the end of Q1 2022.
Commenting on the announcement, Tim McCarthy, Chief Executive
Officer, said:
"We are extremely pleased to see this next positive step for
Lupuzor(TM), with approval from the MHRA to commence the PK study.
We look forward to moving Lupuzor(TM) forward into the optimised
Phase 3 study, in collaboration with our partner Avion, on the
successful completion of the PK study. The study is on track to
deliver results around the end of Q1 2022."
Dr Tim Franklin, Chief Operating Officer, added :
"The ImmuPharma Biotech team in Bordeaux and I are looking
forward to the near-term completion of the PK study. Our CRO,
Simbec-Orion, and other key collaborators including Prof. Sylviane
Muller, have provided invaluable contribution in completing a
robust and improved IMPD to the MHRA. We look forward with Avion to
moving Lupuzor(TM) forward and in parallel, we will continue to
focus on unlocking further value through the other indications
within the P140 platform and the anti-infective programs."
End
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.
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman and Chief Executive
Officer + 44 (0) 207 152 4080
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 +44 ( 0) 20 3650 3650
John Howes
Bob Pountney
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, 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 Simbec-Orion
Simbec-Orion, for the last four decades, has been providing
clinical trial management services across a wide range of
therapeutic indications and phases. The clinical research
organisation with a flexible, specialist approach, they strive to
become a trusted partner for their clients. Their passion as a CRO
is rare diseases and oncology.
Responding to the evolving needs of its clients has made them
the contract research organisation they are today. Offering a
full-service clinical development portfolio, but with the size,
agility, and structure to respond rapidly when needed. With a team
of experienced management, clinical research and scientific
advisory specialists, they deliver precise clinical research with
expertise.
From Phase I clinical pharmacology studies through to Phase III
rescue studies, central laboratory services , and post-marketing,
they are the CRO ready to take on the challenge - whatever the
indication or compound you are passionate about, wherever you are
in your clinical development journey. They will manage every
element of your clinical development, so you can focus on the
science. For more information go to: www.simbecorion.com
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.
About MHRA
The Medicines and Healthcare products Regulatory Agency ("MHRA")
is an executive agency of the Department of Health and Social Care
in the United Kingdom which is responsible for ensuring that
medicines and medical devices work and are acceptably safe. For
more information go to:
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
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