USFDA grants QIDP Designation to Venus Remedies Novel Polymyxin B Formulation

Venus Remedies’ has developed the novel polymyxin-B formulation, VRP-034, using its proprietary Renal Guard technology. The company utilized 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 minimize nephrotoxicity 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% 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 vivo studies.

Key preclinical findings for VRP-034 include:

• Up to 70% 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