Unicycive Therapeutics enrolls first patient in trial for OLC in CKD

Unicycive Therapeutics announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate. OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The primary endpoint for the study will evaluate the tolerability of clinically effective doses of OLC in patients with CKD on dialysis. The secondary endpoints will evaluate safety and pharmacokinetics. There is no statistical analysis required to demonstrate efficacy as bioequivalence to Fosrenol was previously established; and there is no other clinical study required to submit an NDA under the 505(b)(2) regulatory pathway. The trial is expected to enroll 60 evaluable participants. Once participants are enrolled into the trial, they will go through a washout period for two weeks to clear their current phosphate binder from their system. Participants will initially be dosed at 500 mg of OLC three times a day and be titrated to a clinically effective dose that is defined as the dose required to achieve a serum phosphate range of less than or equal to5.5 mg/dL. The maximum dose of OLC tested will be 3000 mg/day. As a reminder, all approved phosphate binders, including Fosrenol, are administered on a dose titration schedule based on the control of serum phosphate. Once titrated to a clinically effective dose, participants will then be treated for four weeks to evaluate serum phosphate levels.