REG - Nuformix PLC - Confirmation of European ODD for NXP002

NuformixAnnouncement

29/05/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250529:nRSc5029Ka&default-theme=true

RNS Number : 5029K  Nuformix PLC  29 May 2025

29 May 2025

 

Nuformix plc

 

("Nuformix" or the "Company")

 

Confirmation of European Orphan Drug Designation for NXP002 Programme in IPF

 

Nuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet
medical needs in fibrosis and oncology via drug repurposing, is pleased to
announce, further to the Company's announcement on 30 April 2025, that the
European Medicines Agency ("EMA") has granted Orphan Drug Designation ("ODD")
in Idiopathic Pulmonary Fibrosis ("IPF") for tranilast, the active drug
substance enabled for inhaled delivery in Nuformix's NXP002 lead programme.

 

ODD in the European Union ("EU") is granted by the European Commission based
on a positive opinion adopted by the EMA Committee for Orphan Medicinal
Products that can demonstrate potential for significant advancement in
treatment of rare and debilitating diseases affecting no more than five in
10,000 individuals in the EU. ODD provides incentives to developers of
medicines for limited patient populations, including 10 years market
exclusivity, protocol assistance (guidance on study design and scientific
evaluation) and regulatory fee reductions.

 

Phil Molyneaux, MD, Professor of Pulmonary Medicine at the Royal Brompton
Hospital, London, commented: "Patients with IPF currently lack treatment
options that significantly alter the course of their disease. They also often
face tolerability issues with existing therapies. Inhaled therapies like
NXP002 offer the potential for improved efficacy by delivering the drug
directly to the lungs, while avoiding the side effects associated with oral
treatments. This approach could represent a meaningful step forward in
addressing the urgent need for better treatment options for patients with
IPF."

 

Dr Dan Gooding, Executive Director, Nuformix, said: "We are delighted to
receive confirmation that Orphan Drug Designation has been granted for our
NXP002 programme in IPF. The EMA award recognises NXP002's potential to
significantly advance IPF treatment, thanks to its ability to modulate key
targets in IPF progression, but also given its potential enhancement of
current standard of care therapies.  Orphan Drug Designation should
significantly support our goal of progressing NXP002 through partnering and
further development activities and, ultimately bringing solutions for fibrotic
ILD indications to patients. We're thrilled that like us, the EMA has
recognised the promise of this potential breakthrough medicine. We will now
submit an application for US FDA orphan drug designation and continue
discussions with potential future licensing partners and will provide further
updates in due course as appropriate."

 

Enquiries:

 

 Nuformix plc
 Dr Dan Gooding, Executive Director  Via IFC Advisory

 CMC Markets
 Douglas Crippen                     +44 (0) 20 3003 8632

 IFC Advisory Limited
 Tim Metcalfe                        +44 (0) 20 3934 6630

 Zach Cohen                          nuformix@investor-focus.co.uk

 

About Nuformix

 

Nuformix is a pharmaceutical development company targeting unmet medical needs
in fibrosis and oncology via drug repurposing. The Company aims to use its
expertise in discovering, developing and patenting novel drug forms, with
improved physical properties, to develop new products in new indications that
are, importantly, differentiated from the original (by way of dosage, delivery
route or presentation), thus creating new and attractive commercial
opportunities.  Nuformix has a pipeline of preclinical assets with potential
for significant value and early licensing opportunities.

 

About IPF

 

IPF is a chronic lung disease characterised by progressive tissue scarring
that prevents proper lung function. It is a progressive, fatal, age-associated
lung disease affecting approximately three out of every one hundred thousand
people in Europe. IPF typically presents in adults 65 or older and is usually
fatal within two to five years after diagnosis.

 

 

 

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 (mailto:rns@lseg.com)
 or visit
www.rns.com (http://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 (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDPKFBQCBKDOPB