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

Trial Meets Milestone With Complete Enrollment

Robert LeBoyer

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Unicycive Therapeutics Inc.

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Summary: Pivotal Trial Achieved Its Safety and Tolerability Endpoints. Unicycive announced top-line results from its pivotal study for OLC (oxylanthanum carbonate) tolerability, safety, and dosing. Side effects leading to discontinuation, its tolerability endpoint, was met with low discontinuation rate. Side effect rates, its safety endpoint, are lower than Fosrenol (lanthanum carbonate). Over 90% of the patients were able to lower their serum phosphate to target levels, with 70% reaching target at the lowest dose tested. An NDA filing is expected in 3Q24.
Trial Design. The trial enrolled 81 patients with chronic kidney disease (CKD) with high phosphate levels (greater than 4.0 mg/dL and less than 7.0 mg/dL for greater than 8 weeks) that were previously controlled with phosphate binders. The objective was to determine the tolerability and safety of clinically effective OLC doses, defined as the dose needed to lower serum phosphate to 5.5 mg/dl or less. 
The study began with an initial 3-week washout period to eliminate previous phosphate binders from the body and allow serum phosphate to rise to levels between 5.5 mg/dL and 10.0 mg/dL. Next, patients went through a titration period. For the first two weeks, they received 1500 mg/day OLC (500 mg three times a day with meals or snacks). Dose was increased every two weeks until their serum phosphate was lowered below 5.5 mg/dL or until they reached a maximum dose of 3000 mg/day. Once achieving the target level or maximum dose, patients were maintained at that dose for 4 weeks. 
The study enrolled a total of 106 patients, with 86 reaching titration and followed as the Safety Population. Out of these patients, 78 entered the Maintenance period. In this group, 7 patients did not have phosphate control, leaving 71 in the Evaluable Population. This exceeded the planned 60 Evaluable patients.
Primary Endpoint. The primary endpoint was tolerability, defined as the discontinuation rate due to treatment related adverse events (TRAEs) during the maintenance period. In the Safety Population, a total of 3 patients out of 86 discontinued due to TRAEs, or 3.5%. The Evaluable Population of 71 patients had only 1 TRAE discontinuation, or 1.4%. In total, 5 patients discontinued due to AEs in the Safety Population, 3 were related to OLC and 2 were deemed unrelated to OLC.
Secondary Endpoint.&nbsp; The Secondary Endpoint was safety, defined as TRAEs occurring in greater than 5% of the patients. All 86 patients were included in the Safety Population. The events reported were diarrhea (9%) and vomiting (6%), which compares favorably with the Fosrenol (lanthanum carbonate) product label, showing rates of diarrhea (11%), vomiting (9%), and abdominal pain (5%). Most treatment-related AEs were mild to moderate in severity with only 2 AEs reported as severe.
Potency Was Greater Than Expected. The study included a 3-week washout period, followed by titration with a starting dose of 1500 mg/day, then increasing dosages every two weeks until phosphate control was achieved. Overall, 90% of the patients were able to reach the target range, including 70% that received maintenance doses lower than 1500mg/day. The patients achieving phosphate control (serum phosphate less than 5.5mg/dl) improved from 59% at the start of the study to 90% at the end of the titration period.
Moving Forward With An NDA Filing.&nbsp;These pivotal trial is the top-line data necessary to file the NDA, and the risk of clinical disappointment has now passed. The final analysis of the primary and secondary endpoints are being prepared for inclusion in an NDA submission. Several components of the NDA have been prepared, and NDA filing is expected to be ready for filing during 3Q24. We had expected the low bill burden to have become a strong marketing advantage, and see that low side effect data as an additional patient benefit for OLC over Fosrenol. We are reiterating our Outperform rating and $6 price target.

Unicycive Therapeutics Inc. (UNCY)

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

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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)

Trial Meets Milestone With Complete Enrollment (UNCY)

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