REG - Immupharma PLC - LUPUZOR UPDATE

ImmuPharmaAnnouncement

07/02/2022 07:00

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RNS Number : 8094A  Immupharma PLC  07 February 2022

 

RNS | 7 FEBRUARY 2022

ImmuPharma PLC

("ImmuPharma" or the "Company")

LUPUZOR™ 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™ pharmacokinetic
("PK") study, as part of the new optimised international Phase 3 trial of
Lupuzor™ 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™ 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™, with
approval from the MHRA to commence the PK study. We look forward to moving
Lupuzor™ 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™ 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 (http://www.immupharma.com) )        + 44 (0) 207 152 4080

 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

 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, metabolic
diseases, anti-infectives and cancer. The lead program, Lupuzor™, 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™ to
fund a new international Phase 3 trial for Lupuzor™ 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
(https://www.simbecorion.com/service/central-laboratory-support/) , 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 (http://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
(https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency)

 

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