Unicycive Therapeutics, Inc. · NASDAQ:UNCY
Unicycive Therapeutics — Technical Presentation (June 2024)
29 slides from Unicycive Therapeutics's technical presentation, Jun 25, 2024
Slide 1: Oxylanthanum Carbonate (OLC) UNI-OLC-201 Pivotal Trial Topline Data
NASDAQ: UNCY Oxylanthanum Carbonate (OLC) UNI-OLC-201 Pivotal Trial Topline Data June 25, 2024
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains certain “forward-looking” statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical or present facts, are forward-looking statement
Slide 3: Pivotal Clinical Trial (UNI-OLC-201)
Pivotal Clinical Trial (UNI-OLC-201) Study Objective Achieved § Demonstrated tolerability and safety of OLC in CKD patients on hemodialysis Tolerability / Safety § Total discontinuations due to adverse events were 5/86 (6%) § 3 treatment-related, 2 not related to treatment § For reference*, Fosrenol
Slide 4: OLC Background
OLC Background Oxylanthanum carbonate (OLC) is an unapproved investigational new drug being developed under FDA’s 505(b)(2) regulatory pathway. If approved, OLC will share substantially the same product label and prescribing information as the reference-listed drug (RLD) Fosrenol (lanthanum carbonat
Slide 5: Oxylanthanum Carbonate (OLC) Product Profile
Oxylanthanum Carbonate (OLC) Product Profile Overview § Potential best-in-class product being developed under FDA’s 505(b)(2) regulatory pathway for the treatment of hyperphosphatemia § If approved, OLC is expected to share substantially the same product label and prescribing information as the refe
Slide 6: Recommended Daily Starting Dose for Phosphate Binders
Recommended Daily Starting Dose for Phosphate Binders Renvela® Oxylanthanum Carbonate (OLC)* Phoslo® MOST PRESCRIBED sevelamer carbonate 800 mg 500 mg calcium acetate 667 mg 2 tablets 3 times per day, swallowed 1 tablet 3 times per day, swallowed 2 tablets 3 times per day, swallowed Volume: 6.5 cm3
Slide 7: Dialysis Patients Experience Excessive Pill Burden: Phosphate Binders Account for Half of the Problem
Dialysis Patients Experience Excessive Pill Burden: Phosphate Binders Account for Half of the Problem The daily pill burden for maintenance dialysis patients is among the highest across various chronic disease states including HIV/AIDS, diabetes mellitus, and congestive heart failure1 • 19 pills per
Slide 8: Regulatory Pathway
CYCIVE HERAPEUTICS INC. Regulatory Pathway
Slide 9: Studies to Support OLC NDA Filing
Studies to Support OLC NDA Filing 505(b)(2) Requirement Studies Conducted* Bridge to Completed 12/2022 Efficacy Demonstrate similar OLC vs Fosrenol ® þ Efficacy Pharmacodynamic to reference drug 1 Bioequivalence Trial Bioequivalence in Healthy Volunteers (Fosrenol) Confirmed Bridge to Bridge to Safe
Slide 10: Study Overview
Study Overview UNI-OLC-201 Topline data from the Oxylanthanum carbonate (OLC) pivotal trial is preliminary and subject to change based on further detailed analysis.
Slide 11: Study Objective and Endpoints
Study Objective and Endpoints Study Objective: To evaluate the tolerability of clinically effective doses (serum phosphate ≤5.5 mg/dL) of OLC in CKD patients on dialysis Primary Endpoint Secondary Endpoints Tolerability: 1) Safety: Tolerability is assessed based on the Safety is assessed based on th
Slide 12: Pivotal Clinical Trial Design
Pivotal Clinical Trial Design Design, endpoints and sample size (n=60 evaluable) agreed on with the FDA Up to 4 Weeks Up to 3 Weeks Up to 6 Weeks 4 Weeks Screening Washout OLC Titration OLC Maintenance Target Serum Phosphate ≥4 to ≤7.5 >5.5 to ≤10 ≤5.5 ≤5.5 Level (mg/dL) Evaluable Population for Pri
Slide 13: Key Eligibility Criteria
Key Eligibility Criteria Key Inclusion Criteria 1. Patient must be ≥18 years of age. 2. Patient has stable chronic kidney disease and is undergoing and compliant with hemodialysis treatment 3 times per week for at least 12 weeks prior to screening 3. Patient has serum phosphate levels of ≥4.0 mg/dL
Slide 14: Enrollment Summary
Enrollment Summary • Safety Population: N=86 patients who entered titration and were treated with at least one dose of OLC • Maintenance: n=78 were eligible to enter maintenance period • Evaluable Population: N=71 patients with serum phosphate ≤5.5 mg/dL at the end of titration and at least one dose
Slide 15: Prior Phosphate Binder and Patient Demographics
Prior Phosphate Binder and Patient Demographics Prior Phosphate Binder n (%) OLC 43 (50%) Patient Demographics (N=86) Renvela (sevelamer carbonate) Phoslo (calcium acetate) 17 (20%) n (%) Auryxia (ferric citrate) 13 (15% Age (years) Velphoro (sucroferric oxyhydroxide) 12 (14%) mean (SD) 62.4 (10.7)
Slide 16: Results: Primary & Secondary Endpoints
Results: Primary & Secondary Endpoints UNI-OLC-201
Slide 17: Primary Endpoint: Tolerability
Primary Endpoint: Tolerability Rate of Discontinuation Due to Treatment-Related Adverse Events during the Maintenance Period (Evaluable Patients) Total discontinuation due to AEs was 5/86 patients (6%) Treatment-Related Patient Population n Percent Discontinuations Evaluable 71 1 1 . 4% Safety 86 3
Slide 18: Primary Endpoint: Tolerability
Primary Endpoint: Tolerability ● OLC-201 is an open-label/non-comparator study design that was agreed upon with the FDA ● We believe that the low rate of OLC treatment-related discontinuations observed in this clinical trial compare favorably to the historical data that was submitted in the original
Slide 19: Secondary Endpoints: Safety & PK
Secondary Endpoints: Safety & PK Safety Treatment-Related Adverse Events in ≥5% Patients • No treatment-related Serious Adverse Events (SAEs) (N=86) Adverse Event n (%) • 6 patients had non-treatment-related SAEs Diarrhea 8 (9%) a • Most AEs were mild-to-moderate; only 2 patients with severe treatme
Slide 20: Adverse Event Profiles of Phosphate Lowering Therapies from FDA-Approved Product Labels
Adverse Event (AE) Profiles of Phosphate Lowering Therapies from FDA-Approved Product Labels * Disclaimer: FDA cautions that because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot to directly compared to rates in the
Slide 21: Serum Phosphate Control
Serum Phosphate Control UNI-OLC-201
Slide 22: Literature Reported Relative Phosphate Binder Potency
Literature Reported Relative Phosphate Binder Potency Relative phosphate-binding coefficient per gram of binder Relative urinary phosphate-lowering effect (calcium carbonate with an index value of 1.0) 2.5 le Vehic 2.0 2.0 1.9 Sevelamer 1.5 1.7 1.5 Index 1.3 Value Calcium 1.0 1.0 1.0 Aluminum 0.75 0
Slide 23: Historical Phosphate Control Data from US-DOPPS Cohort
Historical Phosphate Control Data from US-DOPPS Cohort Serum Phosphorus (3-month average) ≤5.5mg/dL >5.5 mg/dl 100% The Dialysis Outcomes 90% and Practice Patterns 80% Fail to achieve KDOQI guideline target Study (DOPPS) is a 70% 44% prospective cohort study investigating practices 60% related to th
Slide 24: Phosphate Control in Safety Population (N=86) in UNI-OLC-201
Phosphate Control in Safety Population (N=86) in UNI-OLC-201 Prior Phosphate Binder OLC Treatment 100 Percent of Patients 90% ≤5.5 mg/dL 80 >5.5 mg/dL 59% 60 41% 40 20 10% 0 Baseline End of Titration Baseline - Serum phosphate levels at screening before washout End of Titration – includes last serum
Slide 25: Phosphate Control in Evaluable Population (n=71) in UNI-OLC-201
Phosphate Control in Evaluable Population (n=71) in UNI-OLC-201 69% 60 54% Of the 71 evaluable Percent of Patients patients, 69% achieved a 40 target serum phosphate level of ≤5.5 mg/dL at an 20 14% 17% OLC dose of ≤1500 mg/day 1% 6% 9% 0 500 1000 1500 2000 2500 3000 End ofDose (mg/day) Titration (m
Slide 26: OLC Data Results Support NDA Filing
OLC Data Results Support NDA Filing Achieved the Study Objective demonstrating tolerability and safety of OLC Primary Endpoint: Tolerability § Treatment-related discontinuation rate in Evaluable Population of 1.4% (1/71) § Total discontinuations due to adverse events were 5/86 (6%) § 3 treatment-rel
Slide 27: Anticipated Milestones
CYCIVE ERAPEUTICS INC. 7 Anticipated Milestones
Slide 28: OLC Expected Catalysts
OLC Expected Catalysts ü Successful bioequivalence study in healthy volunteers ü FDA alignment on regulatory path ü Completed enrollment in pivotal clinical trial ü Oral and Poster presentations at NKF & ERA (Q2 ‘24) ü Pivotal trial readout (Q2 ‘24) q NDA Filing (Q3 ‘24) q NDA Acceptance & PDUFA dat
Slide 29: Investor Relations
Investor Relations T: (650) 900-5470 ir@unicycive.com
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