$Unicycive Therapeutics (UNCY.US)$ NEWS Unicycive Therapeuti...
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Unicycive Therapeutics Presents Bioequivalence Data on Oxylanthanum Carbonate (OLC) at the National Kidney Foundation Spring Clinical Meeting
Unicycive Therapeutics presented two posters on their lead product, oxylanthanum carbonate (OLC), at the National Kidney Foundation Spring Clinical Meeting. The key points include:
1. OLC shows bioequivalence to lanthanum carbonate, with similar outcomes in mean change in urinary phosphate excretion and no serious adverse events.
2. The study was a Phase 1, randomized, crossover bioequivalence study involving healthy volunteers.
3. A survey of renal dietitians highlighted non-compliance with phosphate binders as a major issue, with OLC's smaller, swallowable tablets potentially improving patient adherence.
4. Findings support OLC as a candidate for a New Drug Application filing with the FDA under the 505(b)(2) regulatory pathway.
1. OLC shows bioequivalence to lanthanum carbonate, with similar outcomes in mean change in urinary phosphate excretion and no serious adverse events.
2. The study was a Phase 1, randomized, crossover bioequivalence study involving healthy volunteers.
3. A survey of renal dietitians highlighted non-compliance with phosphate binders as a major issue, with OLC's smaller, swallowable tablets potentially improving patient adherence.
4. Findings support OLC as a candidate for a New Drug Application filing with the FDA under the 505(b)(2) regulatory pathway.
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