Most people are surprised to learn that chronic kidney disease (CKD) is the fastest growing, non-communicable disease in the United States. 37 million American adults have CKD and more than 600,000 suffer from end-stage renal disease (ESRD). Of these, nearly 500,000 require dialysis to stay alive. In fact, each year, more people die from this silent killer than from breast or prostate cancer.

Hyperphosphatemia (elevated phosphorus levels in the blood) is a common complication of CKD affecting over 80% of dialysis patients.

Uncontrolled phosphorus levels will often cause other complications like heart disease and bone fractures, increasing the risk of hospitalization by up to 38% and the risk of mortality by up to a staggering 102%. Even though there are six Food and Drug Administration (FDA)-approved drugs on the market to treat hyperphosphatemia, 75% of patients with hyperphosphatemia are unable to bring their phosphorus down to target levels Some of the currently available products include Auryxia, produced by Akebia Therapeutics (NASDAQ: AKBA), and Velphoro, from Fresenius Medical Care AG & Co. (NYSE: FMS).

As such, it would appear that the medications currently available on the market are unable to fully address the needs of the patient population. One company from California is looking to do its bit to help change that.

Unicycive Therapeutics Inc. (NASDAQ: UNCY), a Los Altos, California company, is seeking to develop a solution that is more effective than its competitors. The company is developing a proprietary drug called RenazorbTM which is less than 2 years away from potential FDA approval, that binds and eliminates phosphate in the GI tract.

This new drug uses a patented nanoparticle technology that (if approved) Unicycive believes will more effectively reduce phosphorus to target levels. RenazorbTM also offers added convenience to patients because it is swallowed with water instead of having to be chewed.

Recently Unicycive a survey of nephrologists — doctors who specialize in kidney health — and found that their top concerns in managing hyperphosphatemia in their patients was the need for a lower pill burden and better patient compliance.

Many people suffering from hyperphosphatemia also have other comorbidities that require taking other pills, creating a high pill burden. This leads to 62% of patients self-reporting non-compliance — patients neglecting to take their medication because they are overwhelmed by the number and size of the pills that they must take and their side effects.

The efficiency and smaller size of RenazorbTM pills may reduce the pill burden for these patients by 3 to 4 fold. Accordingly, nephrologists say they would prescribe RenazorbTM (once approved) to 34% of their dialysis patients requiring phosphate binder therapy - this is a market-leading figure indicative of the levels of practitioner confidence in the promise for this new drug.

Notably, Unicycive also recently signed an agreement with Lee’s Pharmaceutical (HK) Ltd., a subsidiary of Lee’s Pharmaceutical Holdings Ltd. (OTC: LPCUF), for exclusive distribution rights to RenazorbTM in China and other Asian markets.

The worldwide market for hyperphosphatemia drugs sits at over $2 billion (with over $1 bn of that being the U.S. market). It is expected to achieve a 5.3% compound annual growth rate between 2021 and 2028. Unicycive believes that this leaves the field wide open for a drug that will bring real solutions to patients suffering from inadequate and burdensome medicine for a persistent medical problem worldwide.

“We were delighted to initiate our pivotal bioequivalence trial of Renazorb(™), which keeps us on track to complete the study around year-end and to file a new drug application in 2023,” said Unicycive CEO Shalaba Gupta. He also said that the agreement with Lee’s Pharmaceutical “underscores the potential for Renazorb(™) as a best-in-class phosphate binder worldwide.”

To learn more about the company, visit its website .

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury.

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Anne Marie Fields - Stern Investor Relations