Unicycive Therapeutics Announced That Data From The Company's Oxylanthanum Carbonate Phase 1 Dose Escalation Study In Healthy Volunteers Was Published In The Peer-reviewed Journal, Clinical And Translational Science

The objective of the OLC dose-escalation study was to demonstrate the safety of escalating doses of orally administered OLC in healthy participants. A total of 32 participants were treated with OLC swallowable tablets or placebo tablets dosed three times per day (TID) and randomized 3:1 per arm across four OLC treatment arms of 500 mg, 1000 mg, 1500 mg and 2000 mg administered with meals over four days. The primary endpoint was safety, and the secondary endpoints measured phosphate binding capacity using the surrogate markers of phosphorus excreted in urine and feces and pharmacokinetics of OLC. The drug was well tolerated during the treatment period. Overall, there were no serious adverse events (SAE), severe or life-threatening AEs (Grade 3-4), deaths, or AEs leading to discontinuation. Most treatment-emergent adverse events (TEAE) were mild in severity. Across all treatment arms, urinary phosphorus excretion decreased from baseline in a dose-dependent manner during treatment with OLC and fecal phosphorus excretion increased from baseline.