LOS ALTOS, Calif. - Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a biotechnology company focusing on kidney disease treatments, has announced the publication of positive data from a Phase 1 study of oxylanthanum carbonate (OLC), a drug developed for patients with hyperphosphatemia in chronic kidney disease. With a market capitalization of approximately $79 million, the company maintains a strong liquidity position, as indicated by its current ratio of 3.61. According to InvestingPro analysis, the company appears to be fairly valued based on its current Fair Value assessment. The study results, published in the Clinical and Translational Science journal, showed that OLC was well-tolerated at escalating doses and effectively reduced phosphate absorption in healthy volunteers.
The trial involved 32 participants who received either OLC or placebo tablets three times a day with meals over a period of four days. The study aimed to assess the safety and phosphate-binding capacity of OLC, with a primary focus on safety and secondary endpoints including the measurement of phosphate binding using surrogate markers like phosphorus excretion in urine and feces.
According to the published data, OLC demonstrated a dose-dependent decrease in urinary phosphorus excretion from baseline, indicating reduced phosphate absorption. Additionally, fecal phosphorus excretion increased from baseline across all treatment arms. Importantly, there were no serious adverse events, severe or life-threatening adverse events, deaths, or adverse events leading to discontinuation reported during the treatment period.
OLC utilizes proprietary nanoparticle technology and is a next-generation lanthanum-based phosphate binding agent. It is designed to offer potential benefits in patient adherence due to its lower pill burden, requiring fewer and smaller pills that are swallowed instead of chewed.
The company’s CEO, Shalabh Gupta, MD, expressed satisfaction with the safety findings and the publication of the study. Unicycive is currently seeking FDA approval for OLC via the 505(b)(2) regulatory pathway, with a Prescription Drug User Fee Action (WA:ACT) (PDUFA) date set for June 28, 2025. The New Drug Application (NDA) submission is based on data from this Phase 1 study, along with a bioequivalence study in healthy volunteers, a tolerability study in CKD patients on dialysis, preclinical studies, and chemistry, manufacturing, and controls data.
The global market opportunity for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for more than $1 billion of that total. The company’s stock has shown strong momentum, gaining over 66% in the past six months, while analysts maintain optimistic price targets ranging from $2 to $9 per share. InvestingPro subscribers have access to 10 additional key insights about UNCY’s financial health and growth prospects. Despite existing FDA-cleared medications, a significant percentage of U.S. dialysis patients do not achieve target phosphorus levels, highlighting the need for effective treatments.
The information reported in this article is based on a press release statement from Unicycive Therapeutics, Inc. While the company holds more cash than debt on its balance sheet, InvestingPro data reveals it’s currently burning through cash rapidly, with analysts not anticipating profitability this year. Investors seeking deeper financial analysis and real-time metrics can access comprehensive company data through InvestingPro’s advanced analytics platform.
In other recent news, Unicycive Therapeutics has seen a flurry of activity with its kidney disease treatments. The Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for oxylanthanum carbonate (OLC), a phosphate binding agent designed to treat hyperphosphatemia in patients with chronic kidney disease undergoing dialysis, setting a target action date for June 2025. H.C. Wainwright maintained a Buy rating for Unicycive following this development.
In addition, Unicycive successfully completed its Phase 1 study for UNI-494, a drug aimed at treating acute kidney injury. The study results suggested that UNI-494 was generally safe and well-tolerated, paving the way for a potential Phase 2 trial. Unicycive is also set to present new research on kidney disease therapies at the upcoming American Society of Nephrology Kidney Week.
On the regulatory front, Unicycive is preparing for the potential commercial launch of OLC in the second half of 2025, with the company seeking approval through the 505(b)(2) regulatory pathway. This pathway is supported by data from three clinical studies, additional preclinical studies, and Chemistry, Manufacturing, and Controls (CMC)-related specifications and practices included in the NDA submission. Despite these advancements, Unicycive faces potential delisting from the Nasdaq Market due to non-compliance with the exchange’s listing rules. These are the recent developments for Unicycive Therapeutics.
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