Venus Remedies has announced that its investigational product, VRP-034, has received Qualified Infectious Disease Product (QIDP) designation from the United States Food and Drug Administration (US FDA) for the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults.
Developed by Venus Medicine Research Centre (VMRC), VRP-034 is a novel supramolecular cationic formulation of polymyxin B sulphate, designed to address the nephrotoxic effects associated with conventional polymyxin B therapy.
The QIDP designation, granted under the Generating Antibiotic Incentives Now (GAIN) Act, provides VRP-034 with regulatory benefits, including priority review, eligibility for fast track designation, and an additional five years of market exclusivity upon approval in the United States.
Saransh Chaudhary, CEO of Venus Medicine Research Centre, stated, “Receiving QIDP designation for VRP-034 is a pivotal milestone in our efforts to combat antimicrobial resistance. QIDP recognition for VRP-034 underscores the urgent global need for safer polymyxin-based therapies and validates the strength of our scientific approach.”
The company has developed the novel polymyxin-B formulation, VRP-034, using its proprietary Renal Guard technology. The company utilised kidney-on-a-chip technology (based on Organ-on-a-Chip model) to study established kidney injury biomarkers, including KIM-1. cystatin C, NAG, and NGAL. in response to polymyxin-B, an antibiotic used against multidrug-resistant Gram-negative bacteria.
These insights directly contributed to the refining of its Renal Guard technology forming the foundation of the novel formulation, VRP-034, designed specifically to minimise nephiotoxicity while preserving therapeutic efficacy.
Polymyxins, particularly PMB and colistin, are among the last-resort antibiotics used against Multidrug resistance (MDR) infections. However, their clinical use is severely limited by nephrotoxicity, which affects up to 60 per cent of patients. VRP-034 offers a novel solution by preserving the pharmacokinetics and pharmacodynamics of PMB while significantly reducing oxidative stress and renal cell injury, as demonstrated in multiple in vitro and in viva studies.
Key preclinical findings for VRP-034 include:
- Up to 70 per cent reduction in nephrotoxicity compared to marketed PMB
- Robust efficacy against resistant pathogens in both in vitro and animal models
- Favorable safety profile across multiple toxicity studies using advanced renal biomarkers and human organ-on-a-chip models
This recognition by the US FDA underscores Venus Remedies’ commitment to addressing antimicrobial resistance and its dedication to advancing treatments in infectious disease therapy.