Unicycive reports patient preference for OLC in trial By Investing.com

LOS ALTOS, Calif. – Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a biotechnology company focused on kidney disease treatments, has released initial patient-reported outcomes from its UNI-OLC-201 clinical trial, indicating a strong patient preference for its oxylanthanum carbonate (OLC) over existing phosphate binders. The survey, part of the trial for patients with hyperphosphatemia on dialysis, showed that 79% preferred OLC, citing ease of use and satisfaction.

The trial, which concluded with results reported on June 25, 2024, was designed to assess OLC against patients’ previous phosphate binders. The median daily pill burden for patients on OLC was reduced by half, from a median of six pills per day to three.

Additionally, 98% of patients found OLC easy to take compared to 55% for their prior therapy. At the study’s end, 89% of participants reported satisfaction with OLC, a significant increase from the 49% satisfaction rate with their previous medication.

Dr. Shalabh Gupta, CEO of Unicycive, expressed optimism about the trial outcomes, emphasizing the importance of patient perspective in managing hyperphosphatemia. Dr. Pablo Pergola, the principal investigator, highlighted the positive patient experience and the potential impact on adherence to phosphate-lowering prescriptions, often hindered by side effects and high pill burden.

OLC utilizes proprietary nanoparticle technology and is being developed to address hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The company is now focused on filing a New Drug Application for OLC, which, if approved, could offer a “best-in-class” profile due to its lower pill burden.

Unicycive aims to meet a significant unmet need in the treatment of hyperphosphatemia, as identified by nephrologists in a 2022 survey. The global market for hyperphosphatemia treatment is projected to exceed $2.5 billion in 2023, with U.S. patients struggling to achieve target phosphorus levels despite available treatments.

The initial findings from the OLC trial are preliminary and subject to further detailed analysis, with full results expected to be presented at a future medical conference. This report is based on a press release statement from Unicycive Therapeutics, Inc.

In other recent news, Unicycive Therapeutics has amplified its manufacturing agreement with Shilpa Medicare in anticipation of increased manufacturing needs for oxylanthanum carbonate (OLC), a drug compound under development. The pharmaceutical company also doubled its authorized shares from 200 million to 400 million, a move that could potentially facilitate capital raising, fund new research and development, or enable other corporate activities.

Unicycive has reported positive results from its pivotal clinical trial for OLC, a potential treatment for hyperphosphatemia in chronic kidney disease patients. Additionally, the company’s Annual Meeting of Stockholders resulted in the reelection of four directors and the approval of key proposals, including the Nasdaq 20% Issuance Proposal and the Authorized Share Increase Proposal.

Analyst attention towards Unicycive has been noteworthy, with Noble Capital maintaining its Outperform rating on Unicycive shares, and Piper Sandler initiating coverage on Unicycive, assigning an Overweight rating. The company is expected to report top-line data from a 16-week Phase 2 trial evaluating OLC’s tolerability in chronic kidney disease patients on dialysis in 2024, along with a New Drug Application for OLC anticipated by mid-2024, with potential approval by mid-2025.

InvestingPro Insights

In light of Unicycive Therapeutics’ promising patient-reported outcomes for their OLC treatment, investors may be evaluating the company’s financial health and market performance. According to real-time data from InvestingPro, Unicycive Therapeutics currently holds a market capitalization of 17.9 million USD, with a previous close price of 0.48 USD. The company’s stock price has experienced significant volatility, as evidenced by a 63.38% drop over the last three months.

Two key InvestingPro Tips for Unicycive Therapeutics are particularly relevant given the context of their clinical trial results. Firstly, the company holds more cash than debt on its balance sheet, which could provide financial flexibility as they move towards filing a New Drug Application for OLC. On the flip side, analysts do not anticipate the company will be profitable this year, which is an important consideration for investors eyeing long-term financial sustainability.

For readers interested in a deeper dive into the company’s financial metrics and stock performance, InvestingPro offers additional insights. There are 10 more InvestingPro Tips available for Unicycive Therapeutics at https://www.investing.com/pro/UNCY, which could further inform investment decisions. To access these valuable tips, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.

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