RCS - Infex Therapeutics - First NCFB patient dosed in RESP-X Phase IIa study

UnileverAnnouncement

16/09/2024 08:15

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240916:nRSP2023Ea&default-theme=true

RNS Number : 2023E  Infex Therapeutics Holdings PLC  16 September 2024

 

Infex Therapeutics Holdings plc

("Infex" or the "Company")

 

First NCFB patient dosed in Phase IIa study of RESP-X

 

Potential first-in-class anti-virulence antibody drug to reduce the frequency
of debilitating exacerbations in respiratory patients with chronic Pseudomonas
aeruginosa (Pa) colonisation.

 

Alderley Park, Cheshire, U.K. Infex Therapeutics, a leading anti-infectives
specialist, announces that the first patient has been dosed in a Phase IIa
clinical trial for RESP-X, a new anti-virulence therapy to treat Pseudomonas
aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB)
patients. Pa is a critical factor in this chronic and debilitating respiratory
disease leading to recurring severe episodes of life-threatening infection,
for which there are currently no approved preventative treatments.

 

The Phase IIa trial is a 12 patient, single centre, double-blinded,
placebo-controlled, dose-ranging study to evaluate the safety, initial
efficacy and determine the optimal dosing of RESP-X ahead of a wider Phase IIb
efficacy study. The study is taking  place at the NIHR Clinical Research
Facility in Liverpool University NHS Foundation Trust and will assess two
doses of RESP-X at 6mg/kg and 10mg/kg.

 

RESP-X is a first-in-class anti-virulence antibody targeting chronic Pa
bacterial infections in respiratory diseases. RESP-X is initially being
developed as a long-term treatment to reduce disease flares/exacerbations in
NCFB patients colonised with Pa, a chronic and debilitating respiratory
disease. Colonisation with Pa increases the severity of NCFB, leading to
recurring episodes of debilitating and life-threatening infection, called
exacerbations. There are currently up to six million NCFB patients in major
global markets, of which up to 30% have chronic Pa colonisation. Despite its
prevalence and severity, there are currently no licensed treatments for the
prevention or reduction of infective exacerbations due to Pa colonisation in
NCFB patients.  There is also potential to expand the development of RESP-X
into cystic fibrosis and COPD in addition to acute settings such as hospital
and ventilator-acquired pneumonia and blood stream infections due to Pa.

 

Dr Peter Jackson, CEO of Infex Therapeutics, said: "The start of the phase IIa
study for RESP-X in NCFB patients is an important milestone for Infex, which
will provide valuable insights on dosing as well as early signs of efficacy in
patients ahead of a larger phase II study. RESP-X is a promising new treatment
option for NCFB patients colonised with Pa, a chronic and debilitating disease
that impacts millions of patients around the world for which there are
currently no approved preventative treatment options. The Phase I data
demonstrated an excellent safety and pharmacokinetics profile and I look
forward to progressing RESP-X through phase II."

 

About RESP-X

In-licensed from Japanese pharma company Shionogi, RESP-X is a novel humanised
monoclonal antibody designed to help the body tackle Pa infections, a
hard-to-treat, drug-resistant pathogen recognised by the WHO as a critical
threat to human health.

 

RESP-X does not kill the bacteria directly but deactivates a critical
virulence mechanism, enabling the patient's own immune system to more
efficiently fight the infection. It blocks Pa exotoxin delivery by the Pa type
III secretion system (T3SS). The T3SS is a critical mechanism by which Pa
causes organ injury, evades the immune system and gains a foothold in humans.
By blocking this virulence system RESP-X downgrades the ability of Pa to
attack human tissues and restores the ability of immune cells to control Pa.

 

NCFB is a disease defined by an irreversible and progressive dilatation of
bronchi due to chronic bronchial inflammation. It is characterised by periods
of stable disease, with flare-ups, known as "exacerbations", that increase in
frequency and severity over the patient's lifetime. There are at least eight
million NCFB patients in major markets, of which around 30% have chronic Pa
colonisation. In the UK, the British Lung Foundation estimates there are in
excess of 30,000 NCFB patients.

 

NCFB exacerbations are closely associated with acute bacterial infections,
with Pa being one of the leading causes. In most severe cases, patients have
multiple exacerbations per year, resulting in high hospitalisation and
mortality rates. As the disease progresses there are serious economic impacts
for patients and healthcare systems.

 

For further information please contact:

 

 Infex Therapeutics Holdings plc              www.infextx.com (http://www.infextx.com)
 Dr Peter Jackson, CEO                        T: +44 (0)161 274 9440
 Carl Curran, Business Development Manager

 Walbrook PR Ltd (Media Relations for Infex)  infex@walbrookpr.com (mailto:infex@walbrookpr.com) or T: +44 (0)20 7933 8780
 Stephanie Cuthbert / Louis Ashe-Jepson       Mob: +44 (0)7796 794 663 / +44 (0)7747 515 393

 SP Angel Corporate Finance LLP (Financial Adviser to Infex)                           T: +44 (0)20 3470 0470
 Vadim Alexandre / David Hignell

 Influential (Media Relations for iiCON)      T: +44 (0)161 529 1007
 Chris Hulme

 

About Infex (www.infextx.com (http://www.infextx.com) )

Infex Therapeutics Holdings plc is a leader in critical-priority infectious
diseases, with a broad and diverse pipeline of innovative best-in-class and
first-in-class drug candidates to address the urgent global shortage of novel
anti-infective treatments. The Company is building a differentiated pipeline
through in-house drug discovery, acquisition, co-development and in-licensing
of early stage/pre-clinical candidates, developing them to clinical proof of
concept before licensing to commercial pharma partners.

 

About iiCON: Infection Innovation Consortium (
https://www.infectioninnovation.com/ (https://www.infectioninnovation.com/) )

iiCON is a global collaborative infectious disease R&D programme
established in 2020. Founded with government funding provided through UK
Research and Innovation's flagship Strength in Places Fund, it brings together
industry, academia, and the NHS in a concerted effort with a clear aim: to
combat the growing global threat posed by infectious diseases and save lives
through collaborative innovation.

 

Led by Liverpool School of Tropical Medicine, our consortium partners
Unilever, Liverpool University Hospitals Foundation Trust, University of
Liverpool, Evotec, and Infex Therapeutics are working on number of innovative
and ambitious programmes across iiCON's ten specialist research platforms.

 

About the NIHR Liverpool Clinical Research Facility

Opened in 2009, providing state of the art purpose built facilities, embedded
within the Liverpool University Hospital NHS Foundation Trust which also
provides specialist equipment, 24-hour emergency coverage and access to ITU,
the CRF offers a safe and regulated environment to perform clinical research
trials to the highest possible standards.

 

With pooled expertise and resources from the neighbouring University of
Liverpool and the Liverpool School of Tropical Medicine, as well as a
strategic alliance with one of the global leaders in early phase drug
development (Covance), the CRF offers a wealth of knowledge and experience in
pharmaceutical trials.

 

In addition, with the rapidly expanding databases of volunteers in both
healthy and patient populations the CRF is fully equipped to cover all aspects
of performing clinical trials from phases I-IV.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. 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  NRAGPUMPBUPCGAW