Patient Survey Data From Pivotal Trial Shows Patients Prefer OLC

The Moment We’ve Been Waiting For: OLC Pivotal Trial Meets Endpoints For Phosphate Control

Data Presentations For OLC and UNI-494 Trials Presented

1Q24 Reported With Pivotal OLC Data Coming In 2Q24

Robert LeBoyer

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Unicycive Therapeutics Inc.

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Summary. Unicycive presented data at the European Renal Association (ERA) Congress on its two products in clinical development. There were two presentations on OLC and two on UNI-494, its product for kidney injury. Earlier this month, the company presented data from its bioequivalence study and a market survey study on phosphate binder compliance at the National Kidney Foundation Spring Clinical Meeting. These data presentations met our expectations for the expected outcomes and timeframes.
OLC Data From Clinical Trials Presented At The National Kidney Foundation Spring Clinical Meeting. Unicycive presented data from its Phase 1 bioequivalence study comparing OLC with lanthanum carbonate, the active compound in the phosphate binder Fosrenol. This study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Both groups showed similar outcomes, as measured by mean change in urinary phosphate excretion and demonstrated safety and tolerability. This was the study that established the pharmacodynamic bioequivalence of OLC to Fosrenol for additional trials. As described below, the design of the current OLC trial was included in a poster presented at the European Renal Association Congress.
The second poster at the NKF meeting included data from a survey of renal dieticians (n=100) who help manage patientsâ€™ diet and phosphate levels. The survey is consistent with previous data showing that daily pill burden is a factor in patient compliance, and that OLCâ€™s reduced pill burden could lead to better compliance and patient outcomes. The poster also reports on factors contributing to patient non-compliance to phosphate binder therapy and the features of OLC they found most appealing.
Two OLC Presentations Were Made At The ERA.&nbsp;At the European Renal Association Congress, an oral presentation reported data from a preclinical model testing OLC potency against tenapanor, another drug that is used to reduce serum phosphate in ESRD dialysis patients. Tenapanor works through inhibition of the sodium-hydrogen exchange channel to prevent absorption, in contrast to drugs that bind phosphate in the intestine. The study showed OLC was able to reduce urinary phosphate excretion at levels three times greater than tenapanor. Since the two drugs act through different mechanisms, the possible synergies of the two may be explored in additional studies.
Design of the Current Pivotal Trial Was Presented. A poster described the design of the current pivotal trial to evaluate the safety and tolerability of OLC in hemodialysis patients. The trial has an open-label design with a single arm enrolling about 90 ESRD patients on hemodialysis with high phosphate levels (greater than 4.0 mg/dL and less than 7.0 mg/dL for greater than 8 weeks) requiring phosphate binders. 
The regimen includes a washout period of 3 weeks to raise their serum phosphate levels to between 5.5 and 10.0 mg/dL. Next, patients will go through a 6-week titration period. For the first two weeks, they will receive 1500 mg/day OLC (500 mg three times a day with meals or snacks). In the next period, patients will increase dose every two weeks until lowering their serum phosphate level below 5.5 mg/dL or until they reach a maximum dose of 3000 mg/day. Once achieving the target level or maximum dose, patients will continue for another 4 weeks. Adverse events leading to patient discontinuation will be used as a measure of tolerability, the primary endpoint. Pharmacokinetics of OLC will also be evaluated.
UNI-494 Preclinical and Phase 1 Data Presented In Posters and Oral Presentations. Unicycive presented data from a preclinical study of acute kidney injury (AKI) and from the Phase 1 trial showing the single ascending dose (SAD) treatment stage. In a preclinical model of acute kidney injury, a single dose of orally administered UNI-494 was able to reduce biomarkers related to kidney disease and function, including tubular injury and proximal tubular injury scores. There were also improvements in serum creatinine, a marker of kidney function, and urinary&nbsp;neutrophil gelatinase-associated lipocalin (NGAL), a marker of tubular injury. This indicated potential for UNI-494 development for delayed graft function and related conditions caused by kidney injury.
Phase 1 SAD Study. An oral presentation described the design of the Phase 1 dose single ascending dose (SAD) study to establish the maximum tolerated dose. The double-blind study enrolled 40 healthy volunteers to determine safety, tolerability, and pharmacokinetics. After completion, the 80 mg dose given twice a day (160 mg/day) was selected in the multiple ascending dose (MAD) study. The MAD portion is expected to announce results in late 2024.&#8212;&#8212;&#8212;- page break &#8212;&#8212;&#8212;-
Conclusion.&nbsp;These NKF data presentations for OLC demonstrate its bioequivalence and support our belief that OLC&#8217;s reduction in pill burden&nbsp; could lead to improved compliance and market penetration. The ERA presentations show it is three times more potent than tenapanor, a second-line drug that could be complimentary with OLC. The preclinical study on UNI-494 shows its beneficial actions on functional cells in the kidney, and reports on the Phase 1 dose selection stage. UNI-494 is currently in the MAD portion of its Phase 1 trial, with data expected later in 2024.
We see these presentations as indications of clinical progress for both products. We are reiterating our Outperform rating and $6 price target.

Unicycive Therapeutics Inc. (UNCY)

Data Presentations For OLC and UNI-494 Trials Presented

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Patient Survey Data From Pivotal Trial Shows Patients Prefer OLC (UNCY)

The Moment We’ve Been Waiting For: OLC Pivotal Trial Meets Endpoints For Phosphate Control (UNCY)

Data Presentations For OLC and UNI-494 Trials Presented (UNCY)

1Q24 Reported With Pivotal OLC Data Coming In 2Q24 (UNCY)

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