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RNS Number : 3718Y Infex Therapeutics Holdings PLC 25 February 2025
Infex Therapeutics Holdings plc
("Infex" or the "Company")
Infex signs exclusive license agreement with Venus Remedies Ltd
to advance MET-X through clinical development and commercialisation in India
Alderley Park, Cheshire, U.K. Infex Therapeutics, a leading anti-infectives
specialist, announces that it has signed an exclusive license agreement for
the Indian market (the "Agreement") with Venus Remedies Ltd (NSE: VENUSREM
BSE: 526953) ("Venus Remedies"), an Indian pharmaceutical company, for the
clinical development of MET-X, a resistance bypass treatment that targets
Gram-negative Enterobacterales, for drug-resistant Infections.
Under the terms of the Agreement, Venus Remedies will initially conduct a
Phase I trial for MET-X in combination with the beta-lactam antibiotic
meropenem with healthy volunteers in India. Subject to the successful
completion of the Phase I trial, Venus Remedies will then conduct a combined
Phase II/III trial of MET-X/meropenem in patients with drug resistant
Complicated Urinary Tract Infections (cUTIs), a common hospital acquired
infection that can lead to life-threatening complications.
Venus Remedies will fully fund the trials taking place in India which will be
conducted to international standards and be compliant with FDA, EMA and MHRA
regulations, allowing data to be used for further development and
commercialisation of MET-X by Infex internationally. Infex and Venus Remedies
have the option to expand the Agreement to include other MET-X/beta-lactam
combinations on additional agreed terms. Infex will receive licence fee
payments upon signature and completion of near-term milestones and tiered
double-digit royalty payments on net sales of MET-X/meropenem in India by
Venus.
MET-X is the Company's broad spectrum metallo-beta-lactamase
("MBL")-inhibitor, targeting Gram-negative Enterobacterales. These pathogens
produce MBL enzymes to deactivate beta-lactam antibiotics, such as meropenem,
and evade antibiotic clearance of disease. MET-X blocks MBL resistance,
restoring antibiotic activity. The drug is being developed to be one of the
first broad-spectrum MBL inhibitors to address a wide range of bacterial
species and MBL-resistant strains, such as E.coli and K.pneumoniae. The
treatment has shown best-in-class performance in animal studies to date. The
development of new agents to overcome MBL antibiotic resistance in such
Gram-negative Enterobacterales is a World Health Organisation ("WHO") critical
priority.
In India, meropenem resistance is reported to be as high as 62-87% in WHO
critical priority pathogens like K. pneumoniae and A baumannii as per the
ICMR's Antimicrobial Resistance Research and Surveillance Network-Annual
report 2023, with as high as 50% being directly attributable to MBL
prevalence.
Building upon its robust track record in antibiotic R&D and critical care,
the in-licensing of MET-X aligns with Venus Remedies' strong strategic focus
on tackling AMR. By leveraging its significant manufacturing and marketing
presence of meropenem-one of the most widely used antibiotics for critical
Gram-negative infections-Venus Remedies aims to integrate MET-X with existing
and future antibiotic regimens, further consolidating its position as a
front-runner in the Indian critical care market.
Dr Peter Jackson, CEO of Infex Therapeutics, said: "I am delighted to announce
this license agreement with Venus Remedies, a leading Indian pharmaceutical
company, for the clinical development of our exciting MET-X programme to treat
drug resistant infections in India. The collaboration will ensure MET-X
becomes our second clinical stage drug programme, and as the trials will be
conducted to international standards, we will be in a strong position to make
progress with the MET-X programme with regulatory filings in the UK, US,
Europe and other international markets. As one of the largest manufacturers of
meropenem in India, Venus Remedies is acutely aware of the serious challenge
posed by antibiotic resistance across a broad spectrum of common infections,
such as cUTIs. MET-X has shown best-in-class performance in preclinical
studies and could be a game-changing treatment for those suffering from Gram
negative drug-resistant MBL infections."
Mr Saransh Chaudhary, President, Global Critical Care, Venus Remedies Ltd and
CEO, Venus Medicine Research Centre said: "This early-stage introduction of
MET-X into the Indian market leverages our decades-long dedication to
AMR-focused R&D and our prominent role in critical care and antibiotic
therapies. This partnership is perfectly poised to enhance our antibiotic
arsenal with meropenem and explore further beta-lactam combinations, ensuring
high-quality research and a significant market presence."
Mr Pawan Chaudhary, Chairman and Managing Director, Venus Remedies Ltd said,
"The in-licensing of MET-X is a major step forward in providing breakthrough
solutions for drug-resistant infections, a serious threat to India's
healthcare ecosystem. Our aim is to develop an effective solution against
MBL-producing pathogens, fulfilling a critical healthcare need and continuing
our commitment to transformative therapies and sustained innovation in
critical care."
For further information please contact:
Infex Therapeutics Holdings plc www.infextx.com (http://www.infextx.com) or T: +44 (0)161 274 9440
Dr Peter Jackson, CEO
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
Lianne Applegarth / Louis Ashe-Jepson Mob: +44 (0)7584 391 303 / +44 (0)7747 515 393
Adfactors PR (Media Relations for Venus Remedies) amardeep@adfactorspr.com Mob: +91 9814046480
Amardeep Tiwana
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 Venus Remedies Ltd
Panchkula-based Venus Remedies Ltd (NSE: VENUSREM, BSE: 526953) is among the
10 leading fixed-dosage injectable manufacturers in the world. Having a
commercial presence in 90+ countries with a portfolio of 75 products spread
over Europe, Australia, Africa, Asia-Pacific, Commonwealth States, the Middle
East, Latin America and the Caribbean region, the company has nine globally
benchmarked facilities in Panchkula, Baddi and Werne (Germany), apart from 11
overseas marketing offices. The company holds the GMP approvals from European-
GMP (INFARMED), PIC/S (Malaysia & Ukraine), SAHPRA, UNICEF, TGA, INVIMA
& WHO-GMP, alongside key ISO certifications for quality, environmental,
and occupational health and safety management.
Central to its mission, Venus Remedies is a frontrunner in combating
antimicrobial resistance (AMR) through its dedicated research division, Venus
Medicine Research Centre (VMRC). The company is pivotal in developing advanced
antibiotics and β-lactam/β-lactamase inhibitor combinations aimed at
tackling multidrug-resistant pathogens. Its notable initiatives like GASAR
provide essential data on antibiotic resistance, while the PLEA Trust fosters
antibiotic stewardship. As an influential member of the AMR Industry Alliance,
India AMR Innovation Hub, and Vivli AMR Registry, Venus Remedies shapes global
AMR research and policy. Through strategic collaborations with academic and
health organizations worldwide, the company enhances AMR surveillance and
supports innovative drug development, affirming its leadership in global
healthcare.
About drug resistant complicated Urinary Tract Infections (cUTI)
A Complicated Urinary Tract Infection (cUTI) is a UTI that occurs in someone
with a structural or functional abnormality in their urinary tract, or in
someone with a weakened immune system. It's often caused by
multidrug-resistant Gram-negative bacteria and can lead to life-threatening
complications. cUTIs account for a large part of antibiotic administrations
and are among the most common hospital acquired infections.
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