Dr. Shalabh Gupta, CEO of Unicycive Therapeutics, discusses the company’s focus on kidney care and its lead drug candidate for hyperphosphatemia.
On Company Focus
Q: Can you tell us about Unicycive’s mission and focus?
Dr. Gupta: Unicycive is completely dedicated to kidney care. This is an area with significant unmet medical needs affecting millions of patients worldwide. Chronic kidney disease is a growing epidemic, and we believe our innovative approaches can make a meaningful difference in patients’ lives.
Our focus on underserved areas within nephrology allows us to address gaps in current treatment options. We are particularly excited about our work in hyperphosphatemia, which affects virtually all dialysis patients.
On Lead Drug Candidate
Q: Tell us about OLC and its potential?
Dr. Gupta: OLC, or Oxylanthanum Carbonate, is our lead candidate for treating hyperphosphatemia in chronic kidney disease patients. What makes OLC unique is its improved formulation that offers potential advantages over existing phosphate binders.
The market for phosphate binders is substantial – over $2 billion globally. Current options have limitations including pill burden, side effects, and patient compliance challenges. OLC addresses these issues with a more patient-friendly profile.
On FDA Strategy
Q: What is your regulatory pathway?
Dr. Gupta: We are working closely with the FDA on our resubmission strategy. We have addressed the agency’s previous feedback and are confident in our path forward. Our goal is to bring OLC to patients as quickly as possible while meeting all regulatory requirements.
On Market Opportunity
Q: How do you see the competitive landscape?
Dr. Gupta: The phosphate binder market is large and growing. While there are existing options, we believe OLC’s differentiated profile creates a significant opportunity. Nephrologists and patients are looking for better alternatives, and we aim to provide that with OLC.