UPDATE on LUPUZORT PROGRESS to PHASE 3 with AVION

RNS Number : 1693K

Immupharma PLC

04 May 2022

 

ImmuPharma PLC

("ImmuPharma" or the "Company")

UPDATE on LUPUZOR™ - POSITIVE PROGRESS to PHASE 3 with AVION

ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, is delighted to confirm that final preparations are now underway to progress Lupuzor™ into its new optimised international Phase 3 trial of Lupuzor™ in lupus patients.

Further to the recent positive results from the Lupuzor™/P140 Pharmacokinetic ("PK") study announced on 13 April 2022, we are pleased to announce that Avion Pharmaceuticals ("Avion"), our US partner, has confirmed to us, that they are now requesting final guidance from the US Food & Drug Administration ("FDA"), in order to commence the Lupuzor™ Phase 3 trial.

As we reported, the PK study required by the FDA, demonstrated that the key endpoints had been met and in-line with all human dosing to date, that P140 was safe and well tolerated across all doses and in all subjects.

Commenting on the announcement, Tim McCarthy, Chief Executive Officer, said:

" We are delighted to be announcing positive progress towards the commencement of the new optimised international Phase 3 trial of Lupuzor™ in lupus patients. Following the positive readout from the PK study, we have been working closely with the team at Avion to move Lupuzor™ as quickly as possible to the start of the Phase 3 trial."

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 [phone] 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 Stanford Capital Partners (Joint Broker) Patrick Claridge John Howes Bob Pountney SI Capital (Joint Broker) Nick Emerson [phone] +44 ( 0) 20 3650 3650 [phone]

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 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.

 

END

 

 

MSCSSEFIDEESEDI