TIDMIMM

RNS Number : 3843O

Immupharma PLC

09 February 2021

9 February 2021

ImmuPharma PLC

("ImmuPharma" or the "Company")

Lupuzor(TM) scheduled to commence international Phase 3 trial in Lupus patients in H2 2021

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

As indicated in the 20 November 2020 announcement, Avion Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for Lupuzor(TM), met with the US Food & Drug Administration ("FDA") on 4 December 2020 for a Type 'A' Meeting Request.

Avion has received feedback from the FDA, and has now advised ImmuPharma of the programme of activities in respect to its commitment to schedule next steps.

In response to the FDA input, Avion, in partnership with ImmuPharma, has plans to develop and validate a bioanalytical assay, to confirm the clinical pharmacology and pharmacokinetic ("PK") characterizations of Lupuzor(TM), prior to commencement of the Phase 3 trial.

A final guidance meeting between Avion and the FDA is being planned at which Avion will submit the methodology for assessing PK as part of the Phase 3 trial. This meeting, which is expected to take place in Q2, will also confirm previous submissions to FDA on the study design, clinical end points and approval process.

As indicated in the 20 November 2020 announcement, ImmuPharma initiated the production of a new batch of Lupuzor(TM) clinical trial material specifically for the Phase 3 trial and it can be confirmed that this will be ready for the start of the trial.

As part of the FDA feedback from the meeting on 4 December 2020, it has been clarified that a Special Protocol Assessment ("SPA") will not be applicable and a conditional approval of Lupuzor(TM), whilst the Phase 3 trial is underway, has not been confirmed at this time.

Commenting on the announcement, Dimitri Dimitriou, CEO of ImmuPharma said :

"We are extremely pleased to see the positive progress of Lupuzor(TM) towards the commencement of the international Phase 3 trial with Avion. We will continue to work closely with Avion over the next period to ensure the start of the Phase 3 study remains on schedule for H2 2021."

Art Deas, Chief Executive Officer, Avion Pharmaceuticals added: "Following continued positive dialogue with the FDA and with an agreed clinical and regulatory pathway over the next period, we look forward to moving Lupuzor(TM) ahead later this year."

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                        + 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)      +44 (0) 203 36 8 3550 
    Patrick Claridge 
    John Howes 
    Bob Pountney                                   +44 (0) 203 815 8880 
 
    SI Capital (Joint Broker) 
    Nick Emerson                                   +44 (0) 1483 413500 
   4Reliance (Euronext Growth Listing Sponsor)    +32 (0) 2 747 02 60 
    Jean-Charles Snoy 
 
    Degroof Petercam (Liquidity Provider)          +32 (0) 2 287 95 34 
    Erik De Clippel 
 
    Backstage Communication 
    Olivier Duquaine                               +32 (0) 477 504 784 
    Gunther De Backer                              +32 (0) 475 903 909 
 

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(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 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 .

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 one new therapy, namely GlaxoSmithKline's Benlysta, has 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.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.

END

RESFFFVIFIITIIL

(END) Dow Jones Newswires

February 09, 2021 02:00 ET (07:00 GMT)

Immupharma (LSE:IMM)
Gráfica de Acción Histórica
De Feb 2024 a Mar 2024 Haga Click aquí para más Gráficas Immupharma.
Immupharma (LSE:IMM)
Gráfica de Acción Histórica
De Mar 2023 a Mar 2024 Haga Click aquí para más Gráficas Immupharma.