How a company plans to help fight a silent killer globally with its new kidney disease drug

By David Willey, Benzinga

Los Altos, California

–Direct News–

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 suffer from 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 (high levels of phosphorus in the blood) is a common complication of CKD affecting more than 80% of dialysis patients.

Unchecked phosphorus levels often lead to other complications such as heart disease and bone fractures, increasing the risk of hospitalization by up to 38% and the risk of death by up to 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 back to target levels. Some of the products currently available include Auryxia, produced by Therapeutic against akebia (NASDAQ:AKBA), and Velphoro, from Fresenius Medical Care AG & Co. (NYSE: FMS).

Thus, it would seem that the drugs currently available on the market are not able to fully meet the needs of the patient population. A California company is looking to do its part to help change that.

Will their new pill help solve this growing problem?

Unicycive Therapeutics Inc. (NASDAQ:UNCY), a Los Altos, California company, is looking to develop a more efficient solution than its competitors. The company is developing a patented drug called RenazorbMT which is less than 2 years away from potential FDA approval, which binds and eliminates phosphate in the gastrointestinal tract.

This new drug uses patented nanoparticle technology which (if approved) according to Unicycive will more effectively reduce phosphorus to target levels. RenazorbTM also provides added convenience to patients because it is swallowed with water instead of chewed.

Recently Unicyclive order a survey of nephrologists – doctors who specialize in kidney health – and found that their main concerns in managing hyperphosphatemia in their patients were the need for fewer pills and better patient compliance.

Many people with hyperphosphatemia also have other comorbidities that require taking other pills, creating a high pill load. This leads to 62% of patients self-reporting non-compliance – patients neglecting to take their medications because they are overwhelmed with the number and size of pills they need to take and their side effects.

The efficacy and reduced size of RenazorbTM pills can reduce the intake burden of these patients by 3 to 4 times. As a result, nephrologists say they would prescribe RenazorbTM (once approved) to 34% of their dialysis patients requiring phosphate binder therapy – this is a market leading figure indicating the level of confidence among practitioners in the promise of 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 the exclusive distribution rights of RenazorbTM in China and other Asian markets.

The global market for hyperphosphatemia drugs is over $2 billion (of which over $1 billion is the US market). It is expected to grow at a compound annual growth rate of 5.3% between 2021 and 2028. Unicycive believes this leaves the field open for a drug that will provide real solutions for patients suffering from inadequate and cumbersome medicine for a persistent medical problem. in the whole world.

“We were delighted to initiate our pivotal bioequivalence trial of Renazorb(™), allowing us to complete the study towards the end of the year and file a New Drug Application in 2023,” said Shalaba Gupta. , CEO of Unicycive. He also said the agreement with Lee’s Pharmaceutical “underscores Renazorb(™)’s potential as the best phosphate binder in the world.”

To learn more about the company, visit its website

Unicycive Therapeutics is a biotechnology company developing new treatments for kidney disease. Unicycive’s lead drug, Renazorb, is a new 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.

This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investment advice.

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