REG - N4 Pharma PLC - N4 101 In Vivo Study Results

N4 PharmaAnnouncement

12/05/2025 07:00

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RNS Number : 1308I  N4 Pharma PLC  12 May 2025

 

12 May 2025

 

N4 Pharma plc

 

("N4 Pharma" or the "Company")

 

N4 101 In Vivo Study Results

 

Positive results from first in vivo study of dual-loaded Nuvec® for IBD

 

N4 Pharma plc (AIM: N4P), the UK biotech developing Nuvec®, its proprietary
gene delivery system to enable advanced therapies for cancer and other
diseases, is pleased to announce positive results from its first in vivo study
evaluating the use of its Nuvec® proof-of-concept programme, N4 101, an
orally delivered anti-inflammatory treatment for Inflammatory Bowel Disease
(IBD).

 

Following the successful completion of in vitro profiling in December 2024, N4
Pharma has now completed its first in vivo study using an industry-standard
mouse model of IBD. The study explored the therapeutic potential of orally
administered Nuvec® particles loaded with siRNA alone and combined with mRNA.

 

Over a nine-day dosing period, mice with chemically induced acute IBD received
single (siRNA) or dual (siRNA and mRNA) Nuvec®-loaded formulations, and
versions of these therapies specifically targeted at cells involved in gut
inflammation using modified Nuvec® particles. Samples were collected for
analysis on day 15.

 

Key highlights from the study include:

 

 •        Reduction in inflammation: both single and dual-loaded Nuvec® particles
          demonstrated marked improvements compared with controls across all key
          indicators of colitis, including Disease Activity Index (DAI), colon length,
          and body weight loss.
 •        Marked increase in efficacy achieved with targeting: both the single and dual
          loaded Nuvec® combined with a targeting agent performed better and showed an
          even greater reduction in the inflammatory marker TNF alpha than the
          untargeted therapies.
 •        Sustained therapeutic effect: six days after the final administration, both
          single and dual-loaded targeted Nuvec® particles showed a near complete
          reduction in TNF alpha levels in intestinal tissues.
 •        Effective oral delivery: the study also provides clear in vivo evidence that
          Nuvec® particles successfully deliver therapeutic nucleic acid cargos (siRNA
          and mRNA) to the gut via oral administration, resulting in the sustained
          anti-inflammatory effects observed.

 

Nigel Theobald, Chief Executive Officer of N4 Pharma, commented:

"We are delighted with these very promising in vivo data, which demonstrate a
sustained anti-inflammatory effect in a validated IBD model - a major
milestone for our N4 101 programme. Demonstrating a clear increase in
performance through targeting the treatment to specific cells is the holy
grail of nucleic acid therapeutics, and these results place Nuvec® at the
leading edge of nucleic acid delivery technologies.

"The study also provides good evidence that Nuvec® can successfully deliver
nucleic acid therapies to the gut via oral administration, opening up exciting
new possibilities for orally delivered therapies for gastrointestinal diseases
such as IBD and some cancers.

"This work is at an early stage, but as we move into optimisation studies,
these findings will continue to add to our data set along with the extensive
studies supported by the recent fundraise, to validate Nuvec® as a novel
delivery platform for advanced therapies, strengthening our discussions with
commercial partners.

"We look forward to advancing this programme into the next phase of
development and providing further updates on this and our broader platform
work plans for the coming months in due course."

-      Ends -

 

For more information, please contact:

 

 N4 Pharma plc

 Nigel Theobald, CEO                                                       Via N4 Pharma Investor Hub: investors.n4pharma.com

                                                                         (https://investors.n4pharma.com/)
 Luke Cairns, Executive Director

                                                                         https://investors.n4pharma.com/link/8r6zor
 Submit your questions directly to the management team via the N4 Pharma
 Investor Hub
 SP Angel Corporate Finance LLP                                            Tel: +44 (0)20 3470 0470

 Nominated Adviser and Joint Broker

 Matthew Johnson/Jen Clarke (Corporate Finance)

 Vadim Alexandre/Abigail Wayne/Rob Rees (Corporate Broking)
 Turner Pope Investments (TPI) Limited                                     Tel: +44 (0)20 3657 0050

 Joint Broker

 Andy Thacker

 James Pope
 Northstar Communications Limited                                          Tel: +44 (0)113 730 3896

 Investor Relations

 Sarah Hollins

 

About N4 Pharma

N4 Pharma is a pre-clinical biotech company developing Nuvec®, its
proprietary gene delivery system, to enable advanced therapies for cancer and
other diseases.

 

RNA therapeutics are set to impact the treatment of a wide range of diseases
and Nuvec® has several key advantages for RNA gene delivery including the
ability to deliver multiple RNA therapies in a single particle, ease of
manufacturing, protection of the RNA payload to allow for oral delivery, no
unwanted immune response and excellent stability and storage.

 

N4 Pharma is building out its preclinical data set and working towards
first-in-human clinical data to support significant licensing deals for its
Nuvec® platform with gene therapy partners.

 

N4 Pharma's lead programme, N4 101, is an oral anti-inflammatory product for
IBD which serves as a proof-of-concept programme showcasing all the benefits
of the Nuvec® platform.

 

For further information on the Company visit www.n4pharma.com
(http://www.n4pharma.com) or sign up at
https://investors.n4pharma.com/auth/signup
(https://investors.n4pharma.com/auth/signup) .

 

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