RCS - Infex Therapeutics - RESP-X successfully completes Phase 1 trial
02/11/2023 08:15
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RNS Number : 0956S Infex Therapeutics Holdings PLC 02 November 2023
Infex Therapeutics Holdings plc
("Infex" or the "Company")
RESP-X successfully completes Phase I trial and initiates Phase IIa trial in
NCFB patients
No adverse events reported across all cohorts
Alderley Park, Cheshire, U.K. Infex Therapeutics, a leading anti-infectives
specialist, announces that it has successfully completed dosing in its Phase I
study for RESP-X, the Company's new anti-virulence therapy to treat
Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis
(NCFB) patients. No serious or adverse events ("SAEs") or infusion reactions
were reported, and pharmacokinetics (PK) was dose linear across all four dose
escalations. RESP-X shows a long 30-day half-life, and the potential for a
three-monthly dosing interval in patients.
Following this positive data, Infex has initiated a Phase IIa dose-ranging
study for RESP-X in NCFB patients, which will consist of two cohorts to access
safety and initial efficacy and determine the optimal dosing of RESP-X ahead
of a wider Phase IIb efficacy study. The study will take place at the NIHR
Clinical Research Facility in Liverpool. Infex is currently recruiting
patients for the first patient cohort at 6mg/kg and has received approval to
dose patient volunteers at 10mg/kg, provided there are no adverse events
reported from the first patient cohort of the Phase IIa trial. Dosing for the
first cohort of NCFB patients for the Phase IIa trial is expected to commence
before the end of 2023.
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: "Across the four
cohorts of our Phase I study, RESP-X has demonstrated a robust safety and PK
profile, highlighting that the drug's behaviour in the body was consistent and
predictable as dosing increased. With this now complete, we can commence
dosing our Phase IIa first-in-patient cohorts, in which we will gain insights
into dosing and early indicators of RESP-X's efficacy ahead of a wider Phase
II efficacy study."
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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