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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.
Unicycive Therapeutics (Nasdaq: UNCY) reported its Q1 2024 financial results and provided a business update.
The pivotal clinical trial for its lead asset, oxylanthanum carbonate (OLC), is on track with topline data expected in Q2 2024. Additionally, OLC and UNI-494 will be featured in multiple presentations at upcoming nephrology conferences. The company has completed enrollment in the pivotal OLC trial. UNI-494, aimed at preventing delayed graft function in kidney transplant patients, has progressed through the multiple ascending dose portion of Phase 1 trials with results expected later this year.
Unicycive was granted orphan drug designation for UNI-494 by the FDA, providing potential benefits such as tax credits and market exclusivity. The company completed a $50 million private placement, bolstering its cash position to $48.9 million as of March 31, 2024. However, the company reported a net loss of $21.2 million for Q1 2024, primarily due to increased R&D and administrative expenses.
