Unicycive Therapeutics, Inc. · NASDAQ:UNCY
Unicycive Therapeutics — Corporate Update (December 2022)
12 slides from Unicycive Therapeutics's corporate update, Dec 28, 2022
Slide 1: Renazorb: BE Study Update
NASDAQ: UNCY Renazorb: BE Study Update
Slide 2: Renazorb Background
Renazorb Background 2 • Renazorb • Novel lanthanum - based phosphate binder • In development for the treatment of hyperphosphatemia in CKD patients on dialysis • Regulatory Pathway • Agreement with the FDA on acceptability of 505(b)(2) pathway for registration • Followed FDA BE study guidance for th
Slide 3: Phase 1 Clinical Trial: LDC Well-Tolerated with Dose-Dependent Phosphate Lowering Effect
Phase 1 Clinical Trial: Lanthanum Dioxycarbonate (LDC) was Well - Tolerated with Dose - Dependent Phosphate Lowering Effect 1 Study Design: Open label, dose ranging study (evaluated 4 LDC doses : 1500, 3000, 4500 and 6000 mg/day), in N=32 healthy volunteers Primary endpoint : Phosphorus binding capa
Slide 4: Pivotal Bioequivalence Study Design
Pivotal Bioequivalence Study Design Study Start Fosrenol ® (1000mg/TID) N = 32 Renazorb (1000mg/TID) Screening N = 32 Renazorb (1000mg/TID) Fosrenol ® (1000mg/TID) 4
Slide 5: Renazorb Bioequivalence Study in Healthy Volunteers
Renazorb Bioequivalence Study in Healthy Volunteers 5 Objectives Primary Objective To demonstrate pharmacodynamic (PD) equivalence of orally administered Renazorb 1000 mg TID to orally administered Fosrenol 1000 mg TID in healthy subjects Secondary Objective To compare the safety and tolerability of
Slide 6: BE Study Meets Primary Endpoint
BE Study Meets Primary Endpoint 6 Visit Statistics Renazorb Fosrenol N 75 75 Baseline LS Mean (SE) 859.8 (30.8) 878.1(30.8) Evaluation Period LS Mean (SE) 546.7 (19.3) 546.8 (19.3) Change LS Mean Change (SE) - 320.4 (17.7) - 324.0 (17.7) 90% CI for LS Mean Treatment difference - 45.9, +53.2 Acceptan
Slide 7: BE Study Meets Primary Endpoint
BE Study Meets Primary Endpoint 7 Average of Daily Urinary Phosphorus Excretion (mg/day) At baseline and over 3 - day dosing period
Slide 8: Safety Comparable Between Renazorb and Fosrenol
Safety Comparable Between Renazorb and Fosrenol 8 • Treatment emergent adverse events were comparable between the Renazorb and Fosrenol groups • No subjects in the study experienced a serious adverse event (requiring hospitalization or withdrawal from the study) • There were no deaths in the study
Slide 9: Summary
Summary 9 • Efficacy • Study met the primary endpoint • Bioequivalence established based on the pharmacodynamic endpoint • Reference interval was defined as ц 20% of the LS mean of the primary PD variable for lanthanum carbonate • The 90% CI of the primary PD variable for Renazorb was completely con
Slide 10: Successful Renazorb BE Study Outcome Establishes Bridge to Fosrenol Clinical Data
Successful Renazorb BE Study Outcome Establishes Bridge to Fosrenol Clinical Data 10 • By successfully demonstrating pharmacodynamic bioequivalence between Renazorb and Fosrenol (505(b)(2) reference - listed drug), a bridge to Fosrenol’s already approved clinical efficacy and safety data set is esta
Slide 11: Renazorb Value Proposition
Renazorb Value Proposition Renvela ® sevelamer carbonate 800mg 3 tablets per day Volume : 2.3 cm 3 Renazorb Œ lanthanum dioxycarbonate 1,000mg 9 tablets per day Volume : 9.7 cm 3 Renazorb offers patients a 4 - fold reduction in daily pill burden compared to Renvela — currently the most prescribed ph
Slide 12: Market Opportunity
Market Opportunity • US phosphate binder market current over $1Billion • CMS reimbursement change taking effect in 2025 will increase market substantially • Market research indicates that Renazorb is poised to capture more than a third of the US market 12
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