lnfex signs exclusive license agreement with Venus Remedies Ltd to advance MET-X through clinical development and commercialisation in lndia

Alderley Park, Cheshire, UK,Infex Therapeutics, a leading anti-infectives speialist, anounces that it has signed an exclusive license agreement for the lndian market (the “Agreement”) with Venus Remedies Ltd (NSE: VENUSREM BSE: 526953) (“Venus Remedies”), an lndian 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 lndia. 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 lndia 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 lnfex internationally. lnfex and Venus Remedies have the option to expand the Agreement to include other MET-X/beta-lactam combinations on additional agreed terms. lnfex will receive licence tee payments upon signature and completion of near-term milestones and tiered double-digit royalty payments on net sales of MET-X/meropenem in lndia by Venus.

MET-Xis 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.

ln lndia, 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 lndian critical care market.

Dr Peter Jackson, CEO of lnfexTherapeutics, said: “I am delighted to announce this license agreement with Venus Remedies, a leading lndian pharmaceutical company, for the clinical development of our exciting MET-X programme ta treat drug resistant infections in lndia. 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 ta 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 lndia, 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 lndian 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-Xis a major step forward in providing breakthrough solutions for drug-resistant infections, a serious threat to lndia’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.”

Full PR available here