Designation for Critical Treatment of Bloodstream Infections
Venus Remedies Limited (NSE: VENUSREM, BSE: 526953), a prominent pharmaceutical company specializing in critical care injectables, has announced that the United States Food and Drug Administration (US FDA) has granted Qualified Infectious Disease Product (QIDP) designation to its investigational product, VRP-034. This designation applies to the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults.
Innovative Polymyxin B Formulation
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. This formulation is specifically designed to address the nephrotoxic effects commonly associated with conventional polymyxin B therapy. By utilizing cutting-edge technology, the new formulation enhances the therapeutic benefits while reducing harmful side effects.
Key Regulatory Benefits with QIDP Designation
As per the press release, the QIDP designation, granted under the Generating Antibiotic Incentives Now (GAIN) Act, offers VRP-034 several important regulatory advantages. These include priority review, eligibility for fast track designation, and an additional five years of market exclusivity upon approval in the United States. This milestone is crucial for accelerating the development and availability of VRP-034.
Addressing the Global Threat of Antimicrobial Resistance
Saransh Chaudhary, CEO of Venus Medicine Research Centre, emphasized the importance of this achievement, stating, “Receiving QIDP designation for VRP-034 is a pivotal milestone in our efforts to combat antimicrobial resistance.” The recognition highlights the pressing global need for safer polymyxin-based therapies and validates the scientific rigor behind the company’s approach.
Renal Guard Technology and Kidney-on-a-Chip Insights
Venus Remedies has developed VRP-034 using its proprietary Renal Guard technology. This innovative platform leverages kidney-on-a-chip technology, which is based on the Organ-on-a-Chip model. It is used to study kidney injury biomarkers such as KIM-1, cystatin C, NAG, and NGAL in response to polymyxin B. These insights have played a critical role in refining the formulation. They ensure it minimizes nephrotoxicity while maintaining the drug’s therapeutic efficacy.
Promising Preclinical Findings
Preclinical studies have shown that VRP-034 offers significant advantages over traditional polymyxin B therapies. Key findings include:
- A 70% reduction in nephrotoxicity compared to marketed polymyxin B.
- Strong efficacy against resistant pathogens in both in vitro and animal models.
- A favorable safety profile, demonstrated through multiple toxicity studies using advanced renal biomarkers and human organ-on-a-chip models.
These promising results underscore the potential of VRP-034 to address the challenges posed by multidrug-resistant (MDR) Gram-negative bacteria.
Commitment to Combatting Antimicrobial Resistance
This FDA recognition strengthens Venus Remedies’ commitment to innovation in the fight against antimicrobial resistance (AMR). It also underscores the company’s dedication to addressing the critical unmet needs in infectious disease treatment and improving patient outcomes worldwide.