RCS - Infex Therapeutics - Encouraging Phase I clinical data for RESP-X

London Stock ExchangeAnnouncement

05/04/2023 08:15

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RNS Number : 3947V  Infex Therapeutics Holdings PLC  05 April 2023

 5 April 2023

Infex Therapeutics Holdings plc

("Infex" or the "Company")

 

Interim results demonstrate a favourable safety and tolerability profile for
RESP-X in ongoing Phase I clinical trial

 

Accelerates plans for Phase IIa study

 

Alderley Park, Cheshire U.K. Infex Therapeutics, a leading anti-infectives
specialist, is pleased to announce that RESP-X, the Company's new
anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in
non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising
interim safety and tolerability profile in data from the first cohort of
healthy volunteers in its ongoing first-in-human Phase I clinical trial (the
"Study").

 

The first cohort consisted of eight healthy volunteers who received doses of
RESP-X at 1mg/kg. No serious adverse events were reported, and there were no
treatment-related trends in vital signs, ECG, clinical laboratory evaluations,
or physical evaluations. Additionally, no local tolerability concerns were
reported at the infusion site.

 

Dosing of the second cohort of healthy volunteers will now proceed at 3mg/kg.
The Study is being conducted at the Clinical Research Facility of the
Liverpool University Hospital NHS Foundation Trust.

 

The promising results have accelerated plans for a first-in-patient study
(Phase IIa dose-ranging study), which will consist of two cohorts of NCFB
patients to determine the optimal dose ahead of a wider Phase II efficacy
study.

 

NCFB is a chronic lung condition with a high unmet medical need. It affects
the airways in the lungs, causing them to widen and become damaged. It can
lead to recurrent infections, difficulty breathing, and reduced quality of
life. Colonisation with the bacteria Pa increases the severity of the illness,
leading to recurring episodes of life-threatening infection and there are
currently no approved preventative treatments. RESP-X shows promise as a
potential treatment for NCFB patients with Pseudomonas aeruginosa
colonisation.

 

Dr Peter Jackson, CEO of Infex Therapeutics, said: "The success of the first
cohort of this Phase I clinical trial for RESP-X is encouraging, and we are
eager to move forward with the next steps of the Study. With further research
and development, RESP-X could become a critical new preventative treatment
option for NCFB patients with Pseudomonas aeruginosa colonisation."

 

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 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

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.

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