Infex Therapeutics Holdings PLC

Venus Remedies Ltd. has signed an exclusive licensing agreement with UK-based Infex Therapeutics for the development and commercialization of MET-X in India. MET-X is a novel metallo-beta-lactamase (MBL) inhibitor designed to combat drug-resistant Gram-negative bacterial infections. This strategic collaboration grants Venus Remedies the rights to spearhead clinical development, regulatory approvals, and commercialization of MET-X in India, focusing on its integration with meropenem to tackle infections resistant to conventional treatments. India faces a significant healthcare challenge with high rates of meropenem resistance, reported at 62-87 percent in WHO-critical priority pathogens like Pseudomonas aeruginosa and Klebsiella pneumoniae. With no approved MBL inhibitors currently available in the country, MET-X is set to be a game-changer in combating antimicrobial resistance in hospital settings. Venus Remedies will initiate Phase I clinical trials in India, testing MET-X in combination with meropenem. Future trials will target complicated urinary tract infections (cUTIs), a prevalent issue in hospital environments. All clinical trials will adhere to international standards, complying with FDA, EMA, and ICMR guidelines, which will also support potential global commercialization efforts. Commenting on the partnership, Saransh Chaudhary, President of Global Critical Care at Venus Remedies and CEO of Venus Medicine Research Center, stated that the early-stage introduction of MET-X into the Indian market aligns with the company’s long-standing expertise in AMR-focused research and development, as well as its leadership in critical care therapies. He emphasized that this collaboration will strengthen Venus Remedies’ antibiotic pipeline, ensuring high-quality research and a strong market presence. Pawan Chaudhary, Chairman and Managing Director of Venus Remedies Ltd, highlighted that the in-licensing of MET-X marks a significant milestone in the company's commitment to addressing drug-resistant infections in India. He reiterated the company’s aim to develop a highly effective solution for MBL-producing pathogens, reinforcing its dedication to transformative therapies and continued innovation in critical care. Dr. Peter Jackson, CEO of Infex Therapeutics, expressed his enthusiasm for the partnership, stating that this agreement will facilitate the comprehensive clinical development of MET-X in India. He noted that by leveraging Venus Remedies’ robust expertise in critical care antibiotics, MET-X’s progress can be accelerated, ensuring its availability in global markets, including the UK, US, and Europe. With this agreement, Venus Remedies continues its mission to provide cutting-edge solutions in antimicrobial resistance and strengthen its leadership in India's pharmaceutical landscape.

New Delhi: In a bid to tackle the Meropenem resistance , a drug marketed by Venus Remedies , the Indian drugmaker has acquired the commercial rights of an under-trial MBL inhibitor developed by a UK-based anti-infectives specialist Infex Therapeutics . The Indian drug maker has entered into an exclusive license agreement with Infex Therapeutics, to market its novel metallo-beta-lactamase (MBL) inhibitor MET-X in India and is looking to integrating MET-X with meropenem to tackle drug-resistant Gram-negative bacteria. As per the company it will commence the Phase I trial involving healthy volunteers in India, evaluating MET-X in combination with meropenem and following successful Phase I outcomes, it will move to Phase II/III trials targeting drug-resistant Complicated Urinary Tract Infections (cUTIs), prevalent in hospital settings. “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,” Saransh Chaudhary, President, Global Critical Care, Venus Remedies and CEO, Venus Medicine Research Centre said. “By leveraging Venus Remedies’ robust expertise in critical care antibiotics, we can accelerate MET-X as our second clinical-stage drug program. The international standards of these trials will also support future regulatory filings in the UK, U.S., Europe, and other global markets, “ Dr. Peter Jackson, CEO, Infex Therapeutics, added. In a release, the company stated, the acquisition is part of its broader strategy and its position in meropenem marketing and manufacturing will facilitate the integration of MET-X into existing and prospective antibiotic strategies. Moreover, the company also stated that, the agreement between the two grants an option to expand their collaboration to include other MET-X/beta-lactam combinations under mutually agreed terms. MET-X, a novel metallo-beta-lactamase (MBL) inhibitor, has shown best-in-class performance in preclinical studies and the Indian drug maker expects it to overcome the drug resistance among patients suffering from Gram-negative, MBL-resistant infections. Attributing to the ICMR Antimicrobial Resistance Research and Surveillance Network-Annual report 2023, Venus highlighted that, meropenem resistance in India is as high as 62-87 per cent, with up to 50 per cent linked to MBL prevalence and currently there are no approved MBL inhibitors in the country. By Online Bureau ,

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announces today that its partner Infex Therapeutics has signed an exclusive license agreement for the Indian market with Indian pharmaceutical company Venus Remedies Ltd for the clinical development of its metallo-beta-lactamase-inhibitor MET-X, targeting Gram-negative Enterobacterales. Under the terms of the agreement, Venus 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 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. 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 originates from Medivir’s Metallo Beta Lactamase (MBLI) program aimed at addressing the threat of resistant bacteria and was outlicensed in 2017 (the “Agreement”) to the AMR Centre (now Infex Therapeutics) in England. Under the terms of the Agreement, Medivir is entitled to a share of potential future revenue. Read more: Press Release Infex. For additional information, please contact; Magnus Christensen, CFO, Medivir AB Telephone: +46 8 5468 3100 E-mail: magnus.christensen@medivir.com About Medivir Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a drug candidate designed to selectively treat cancer cells in the liver and to minimize side effects. Collaborations and partnerships are important parts of Medivir’s business model, and the drug development is conducted either by Medivir or in partnership. Medivir’s share (ticker: MVIR) is listed on Nasdaq Stockholm’s Small Cap list. www.medivir.com. About Infex 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. www.infextx.com. Attachments Press Release (PDF)