Unicycive Therapeutics, Inc. UNCY, a clinical-stage company, issued a letter to its shareholders providing corporate updates and key upcoming milestones for the company in 2024. Following the issuance, shares of the company surged 18.3% on Jan 23, as the investors cheered the encouraging pipeline progress. Shares of the company gained 6.8% in the after-market hours.

The company is currently evaluating its lead candidate, Oxylanthanum Carbonate (OLC), in a pivotal clinical study to evaluate the tolerability of OLC in chronic kidney disease (CKD) patients on dialysis. Top-line results from the study are expected in the second quarter of 2024.

OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology. UNCY is developing OLC for hyperphosphatemia associated with kidney diseases.

In the past year, shares of Unicycive have rallied 61.2% against the industry’s 5.5% fall.

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The pivotal study was initiated after Unicycive aligned with the FDA regarding the overall data package required to file a New Drug Application (NDA) for OLC for the hyperphosphatemia indication. The regulatory body had also agreed with the company regarding the clinical study design, including sample size, duration of treatment and the primary endpoint of the study.

In 2022, Unicycive reported results from a previous bioequivalence study that measured OLC’s efficacy in healthy volunteers. It was observed that the drug was equivalent to the already approved reference drug, Fosrenol (lanthanum carbonate).

UNCY is looking to address a significant unmet medical need with its investigational hyperphosphatemia candidate, OLC.

Per the company, the novel characteristics of OLC are expected to reduce the pill burden volume of dialysis patients by more than four-fold compared with the most prescribed phosphate binder. OLC is also an easier-to-use formulation as the tablets are swallowed whole with water and not chewed.

UNCY believes that OLC has the potential to be a best-in-class treatment in the multibillion-dollar hyperphosphatemia market.

In the press release, Unicycive stated that the ongoing phase III pivotal study is the last major component to complete the data package required to file an NDA for OLC with the FDA. The NDA submission is anticipated around mid-year 2024.

Additionally, the company also continues to advance its second compound UNI-494, which is currently being developed for the treatment of acute kidney injury and CKD. UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator.