RCS - Infex Therapeutics - RESP-X dose escalation approved
18/08/2023 08:15
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RNS Number : 6833J Infex Therapeutics Holdings PLC 18 August 2023
Infex Therapeutics Holdings plc
("Infex" or the "Company")
Approval for dosing final RESP-X Phase Ia cohort and first-in-patient Phase
IIa
RESP-X continues to exhibit strong safety and tolerability profile
Alderley Park, Cheshire, U.K. Infex Therapeutics, a leading anti-infectives
specialist, announces it has received approval to commence dosing the final
Phase Ia cohort of healthy volunteers and to proceed to dosing the first
cohort in the first-in-patient Phase IIa dose-ranging study for RESP-X, the
Company's new anti-virulence therapy to treat Pseudomonas aeruginosa (Pa)
infections in non-cystic fibrosis bronchiectasis (NCFB) patients.
The final cohort of Phase Ia healthy volunteers will receive doses of RESP-X
at 10mg/kg. Interim data from the first three cohorts demonstrated that RESP-X
was well tolerated, with no serious adverse events reported.
The Phase IIa study will consist of two cohorts of NCFB patients and determine
optimal dosing of RESP-X ahead of a wider Phase II efficacy study. The first
cohort of patients in the Phase IIa study will receive doses of RESP-X at
6mg/kg.
RESP-X is a first-in-class immune infection antibody in-licensed from Japanese
pharma company Shionogi targeting chronic Pa bacterial infections in NCFB
patients. Colonisation with Pa increases the severity of NCFB, leading to
recurring episodes of life-threatening infection. There are currently at least
eight million NCFB patients in major global markets, of which 30% have chronic
Pa colonisation. Despite its prevalence and severity, there are currently no
approved treatments for Pa colonisation in NCFB patients.
Dr Peter Jackson, CEO of Infex Therapeutics, commented: "It is pleasing to see
that RESP-X continues to exhibit a strong safety and tolerability profile,
with approval now received to dose the final cohort of the Phase Ia study.
Importantly, we now have approval to begin dosing the first cohort of the
first-in-patient Phase IIa dose-ranging study, to identify the optimal dosing
of RESP-X ahead of a wider Phase II efficacy study. We believe RESP-X is a
potential blockbuster opportunity targeting an urgent unmet medical need, for
which there are currently no approved treatments."
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
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 non-cystic fibrosis bronchiectasis (NCFB)
Non-cystic fibrosis bronchiectasis (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 Pa colonisation.
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