Unicycive Therapeutics Says Endpoint Reached in Hyperphosphatemia Drug Trial

 Biotech firm Unicycive Therapeutics Inc. said the primary endpoint was met in its bioequivalence study comparing Renazorb, its investigational treatment for hyperphosphatemia in chronic kidney disease patients on dialysis, with Fosrenol.

The results are from a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between Renazorb and Fosrenol. The study enrolled 40 subjects in each treatment arm.

The study design, including the dose, primary endpoint and sample size, was reviewed and aligned by the U.S. Food and Drug Administration before the initiation of the study, the company said. The FDA previously said in confirmatory guidance that the study would satisfy all clinical regulatory requirements and that no other clinical studies would be required for a New Drug Application, Unicycive said.

Shares jumped more than 34% to 90 cents a share.

Renazorb could reduce the pill burden that patients endure with currently available medications, the company said. Despite the availability of several FDA-cleared medications, 75% of U.S. dialysis patients fail to achieve the recommended phosphorus levels, the company said. Unicycive said research suggests the top reason for the unmet medical need is related to the high pill burden.

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