USFDA grants QIDP Designation to Venus Remedies Novel Polymyxin B Formulation
Mumbai: Venus Remedies Limited, a pharmaceutical company specializing in critical care injectables, has announced that its investigational product VRP-034 has been granted Qualified Infectious Disease Product (QIDP) designation by 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), the R&D division of Venus Remedies, VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate, uniquely developed 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 significant regulatory benefits, including priority review, eligibility for fast track designation, and an additional five years of market exclusivity upon approval in the United States.
“Receiving QIDP designation for VRP-034 is a pivotal milestone in our efforts to combat antimicrobial resistance,” said Saransh Chaudhary, CEO, Venus Medicine Research Centre. “QIDP recognition for VRP-034 underscores the urgent global need for safer polymyxin-based therapies and validates the strength of our scientific approach.”
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
