Unicycive OLC pivotal trial meets primary endpoint; NDA submission planned Q3 2024

Unicycive Therapeutics, Inc.

Primary endpoint achieved: only 1.4% treatment-related discontinuation in evaluable population (n=71), vs 14% for Fosrenol.
Secondary safety endpoint: no treatment-related SAEs; most AEs mild-moderate; diarrhea (9%) and vomiting (6%) most common.
After washout, 90% of safety population (77/86) achieved phosphate ≤5.5 mg/dL at end of titration with OLC.
NDA submission via 505(b)(2) pathway anticipated Q3 2024, supported by bioequivalence and preclinical data.
Study enrolled 106 patients; OLC demonstrated tolerability at clinically effective doses (up to 3000 mg/day).

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