Update : FDA confirms 4 Dec for Type 'A' meeting

RNS Number : 9464F

Immupharma PLC

20 November 2020

 

20 November 2020

ImmuPharma PLC

("ImmuPharma" or the "Company")

FDA confirms 4 December 2020 for Type 'A' meeting to discuss guidance on forthcoming international Phase 3 trial of Lupuzor™ in Lupus patients

ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the specialist drug discovery and development company, announces an update on the announcement issued on 10 November 2020, in respect to the new optimised international Phase 3 trial of Lupuzor™ in systemic lupus erythematosus ("SLE"), a potentially life-threatening auto-immune disease.

The US Food & Drug Administration ("FDA") has now confirmed the date of 4 December 2020 for a Type 'A' Meeting Request, with Avion Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for Lupuzor™.

As part of the Type 'A' Meeting, Avion has asked the FDA for guidance on the following:

· Key aspects of the study design, clinical end points and approval process for Lupuzor™; and

· Consideration by the FDA for a conditional approval of Lupuzor™, whilst the Phase 3 trial is underway.

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 delighted that the FDA are expediting the Type 'A' Meeting for early December 2020.  We look forward to providing a further update to the market following confirmation from Avion of the FDA's guidance post this meeting."

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) Patrick Claridge John Howes Bob Pountney SI Capital (Joint Broker) Nick Emerson [phone] [phone] [phone] 4Reliance (Euronext Growth Listing Sponsor) Jean-Charles Snoy Degroof Petercam (Liquidity Provider) Erik De Clippel Backstage Communication Olivier Duquaine Gunther De Backer [phone] [phone] [phone] [phone]

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™, 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 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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