Venus Remedies to co-develop antibiotic resistance blocker with UK firm

Venus Remedies is working with UK-based Infex Therapeutics for the clinical development of a drug that helps reduce resistance to beta lactam antibiotics like Meropenem.

 

Antimicrobial resistance (AMR) is a burning problem in India and the world, and MBL inhibitors are drugs that prevent bacterial enzymes MBLs from inactivating beta-lactam antibiotics. MBLs are a threat to public health because they make many antibiotics ineffective. No approved MBL inhibitors currently exist in the country and this is an unmet medical need at the moment.

 

AMR occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines.

 

The drug, MET-X (metallo-beta-lactamase (MBL) inhibitor), is Infex Therapeutics’ broad spectrum MBL-inhibitor, targeting Gram-negative bacteria. 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. Venus Remedies will spearhead the clinical development of the drug, registration, as well as commercialisation in India. The company’s stock went up by almost 3 per cent in afternoon trade on Tuesday on BSE.

 

The initial development phase will focus on integrating MET-X with meropenem to tackle drug-resistant Gram-negative bacteria, with Venus Remedies holding exclusive marketing rights within India.

 

In India, meropenem resistance is reported to be as high as 62-87 per cent in WHO critical priority pathogens like K. pneumoniae and A. baumannii, according to the Indian Council for Medical Research (ICMR) Antimicrobial Resistance Research and Surveillance Network- Annual report 2023, with as high as 50 per cent being directly attributable to MBL prevalence.

 

Saransh Chaudhary, president, Global Critical Care, Venus Remedies Ltd, and CEO, Venus Medicine Research Centre told Business Standard that there are roughly around 250,000 deaths that happen due to carbapenem resistance globally.

 

Meropenem is a subset and the most widely used carbapenem. So, one can estimate that roughly 20 per cent of these deaths happen in India.

 

“But the true number is probably going to be a little bit higher because in India, the meropenem is one of the most widely used and is actually amongst the top 10 most described drugs in the country,” he added.

 

He pointed out that India is now at the epicentre of superbugs because of the very high usage of antibiotics and prescription lapses.

 

Two million deaths are projected to occur in India alone due to AMR by 2050. Globally, this number can touch 10 million.

 

Under the terms of the agreement, Venus Remedies will commence with a phase-I trial involving healthy volunteers in India, evaluating MET-X in combination with meropenem. Following successful phase-I outcomes, the focus will shift to Phase II/III trials targeting drug-resistant complicated Urinary Tract Infections (cUTIs), prevalent in hospital settings.

 

The India trials will adhere to international standards, the company claimed, adding that these would be compliant with regulations from the FDA, EMA, and MHRA, which will also support further development and global commercialisation efforts for MET-X.

 

Chaudhury said that they plan to initiate phase-1 trials next year. The study would take about a year to complete.

 

“Hence, we are also hoping that we can do a combined pivotal study given that the combination is going to address a major unmet medical need. And that trial is going to start sometime in FY28 and will likely take about two to three years to complete depending on the sample size and the recruitment that we do. We should be in a position to launch the product or file for regulatory approvals around 2030 with the market entry anticipated anywhere around 31-32,” he explained.

 

Peter Jackson, CEO of Infex Therapeutics, said, “By leveraging Venus Remedies’ robust expertise in critical care antibiotics, we can accelerate MET-X as our second clinical-stage drug programme. Crucially, the international standards of these trials will also support future regulatory filings in the UK, US, Europe, and other global markets. MET-X has shown best-in-class performance in preclinical studies and could be game-changing for patients suffering from Gram-negative, MBL-resistant infections.”

 

Venus Remedies has been actively working in the area of AMR and antibiotic stewardship. It has a strong position in meropenem marketing as well as manufacturing. This would facilitate the integration of MET-X into existing and prospective antibiotic strategies. The agreement grants both Infex Therapeutics and Venus Remedies the option to expand their collaboration to include other MET-X or beta-lactam combinations under mutually agreed terms.

 

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 company claimed.

 

The development of new agents to overcome MBL antibiotic resistance in such Gram-negative bacteria is a World Health Organisation (WHO) critical priority.

 

Pawan Chaudhary, chairman and managing director, Venus Remedies Ltd, added, “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 critical healthcare needs and continuing our commitment to transformative therapies and sustained innovation in critical care.” 

Vital signs

 

• Clinical trials to start next year, and drug can be in market by 2031-32
• No approved MBL inhibitor exists in India at present
• Meropenem is one of the widely prescribed antibiotics in India