Unicycive Therapeutics publishes corporate presentation on kidney disease drug pipeline
UNCY•Market opportunity, trial results and cash runway
Unicycive positioned OLC for a more than $1 billion U.S. hyperphosphatemia market, citing more than 550,000 U.S. dialysis patients, with about 80% using phosphate binders.
In the pivotal study, there were no treatment-related serious adverse events, and discontinuations due to adverse events were 6% in 86 patients.
The company said cash runway is projected into 2027 to support a potential OLC approval and launch. UNI-494 remains in development for acute kidney injury.
Corporate presentation highlights OLC as lead CKD program
Unicycive Therapeutics highlighted oxylanthanum carbonate (OLC) as its lead program for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, with approval expected near-term pending NDA resubmission.
The company said the complete response letter was tied to third-party manufacturing deficiencies. An FDA inspection of the contract manufacturer is expected in the near term, and label and packaging discussions are ongoing.
