Update on submission to the FDA

RNS Number : 7346Y

Immupharma PLC

11 September 2020

 

  11 September 2020

ImmuPharma plc

("ImmuPharma" or the "Company")

Update on submission to the FDA for a Special Protocol Assessment (SPA)

for the forthcoming international Phase III 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 27 July 2020, in respect to the submission to the US Food & Drug Administration ("FDA") of a SPA for Lupuzor™'s Phase III trial in Lupus patients.

In ImmuPharma's discussions with Avion Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for Lupuzor™, Avion has confirmed that, whilst the review period by the FDA for an SPA request is normally up to 45 days (which has now passed), Avion has as yet not received a response from the FDA and as such the file is still in the review queue, due to the current workload at the FDA.

ImmuPharma will provide an update to the market as soon as Avion has received a response from the FDA and notified ImmuPharma.

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, anti-infectives, metabolic diseases and cancer. The lead program, Lupuzor™, is a first-in class autophagy immunomodulator which is in Phase III for the treatment of systemic lupus erythematosus (lupus / SLE). Lupus is an autoimmune disease which if left untreated can be fatal. 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 III trial for Lupuzor™ and commercialise in the US. For additional information about ImmuPharma please visit www.immupharma.com. ImmuPharma's LEI (Legal Entity Identifier) code: 213800VZKGHXC7VUS895.

 

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