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Unicycive Therapeutics, Inc. CEO, Shalabh Gupta on how they are Bringing Innovation to Treatments for Kidney Diseases

Unicycive Therapeutics, Inc. | Logo

Unicycive Therapeutics, Inc. | Shalabh Gupta | CEO

Shalabh Gupta, CEO, Unicycive Therapeutics, Inc.

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CEOCFO Interviews Unicycive Therapeutics, Inc. CEO Shalabh Gupta, about their effort to Improve Quality of Life for Kidney Disease Patients

Unicycive Therapeutics, Inc. (NASDAQ:UNCY)

One of the main attractions for Renazorb is that it provides an ideal phosphate lowering agent that can be taken three times daily in a small pill size that can be swallowed (not chewed).”
— Shalabh Gupta

LOS ALTOS, CALIFORNIA, US, October 6, 2022 / -- CEOCFO Magazine, an independent business and investor publication that highlights important technologies and companies, today announced an interview with Shalabh Gupta, CEO of Los Altos, CA -based Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a company bringing innovation to kidney disease treatments.

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Addressing why he went from practicing physician to CEO of Unicycive Therapeutics, Inc. during the interview with CEOCFO’s Senior Editor Lynn Fosse, Shalabh Gupta said, “I am trained in Internal Medicine (Internship), Physical Medicine and Rehabilitation (Residency) and Cardiac Rehabilitation (Fellowship). I did my residency and clinical training in a fellowship in New York City. After my fellowship training, I was taking care of patients with cardiac problems in the acute in-patient setting at NYU Hospital, where I also had a faculty appointment with attending physician privileges. Physicians do what I am doing today, in the way they take care of patients to help them to get better. I found that if I could get involved in the innovation aspect of healthcare, I could help bring new ideas and new technologies to more patients. It would give me the opportunity to impact -- instead of one patient at a time -- perhaps thousands and millions of patients by bringing new products to the market. That is my inherent desire: to bring new medicines and technologies to market, so that patients, physicians and society as a whole can benefit.”

Describing hyperphosphatemia and how it relates to kidney disease, Shalabh Gupta told CEOCFO, "Having a high level of phosphate in your blood is known as hyperphosphatemia. Phosphate is an electrolyte, which is an electrically charged substance that contains the mineral, phosphorus. Your body needs some phosphate to strengthen your bones and teeth, produce energy, and build cell membranes. Yet in larger-than-normal amounts, phosphate can cause bone and muscle problems and increase your risk for heart attacks and strokes. Hyperphosphatemia is common in patients with kidney disease, particularly those with chronic kidney disease. This is because the kidneys act as a filter for our blood. When the kidneys are damaged or diseased, they no longer perform this task well.”

Dr. Gupta continued describing their treatment for hyperphosphatemia, “Renazorb is a novel phosphate lowering drug, that utilizes nanoparticle technology, which allows us to make smaller pills that can bind the phosphate in the body and take it out in the stool. Renazorb is based on a proprietary compound that was originally developed as lanthanum dioxycarbonate. It was initially developed by a company that was working on car batteries, and they were trying to figure out how to make car batteries smaller, by using nanoparticle technology. As you know, technology and innovation are cross disciplinary applications. In this case, the nanoparticle technology allows us to make the pills to be smaller. Lanthanum, the drug Renazorb is based on, is one of the most potent phosphate lowering drugs approved and on the market. We are combining a proven phosphate lowering agent, lanthanum, and then using nanoparticle technology to make the pills smaller and, therefore, easier to take and easier to remain compliant with the prescribed dosing. With Renazorb, we are able to provide patients a solution that allows them to take one pill with each meal -- one pill with breakfast, one pill with lunch, one with dinner--and be able to adequately control their phosphate.”

As for how Renazorb differs from other medications currently on the market, Shalabh Gupta shared, “There are currently other medications on the market, but many of them require patients to take 9 pills, 12 pills, or 15 pills per day. Some of these drugs require 15 pills per day, which means the patient is taking 5 pills with each meal. Other drugs may require a fewer number of pills, but they are giant pills in size, making them difficult to swallow. Another of these medications was based on an original lanthanum-based drug that required patients to chew the pills. These pills are based on heavy metals, so chewing them is not necessarily very pleasant, or even easy to do. I also want to add that these patients who are on dialysis and need phosphate lowering pills, may already be taking anywhere between 20 to 30 pills per day for other conditions related to their health. Imagine taking 20 to 30 pills per day! If you think about it, that is a lot of medicine, and these are not patients who are taking these pills for one day, one week or one month. They are on these regimens for the rest of their lives, so compliance becomes a big challenge. For patients who are on dialysis and who have hyperphosphatemia, almost 50% of their pill burden can be attributed to their phosphate lowering drugs. So you can see why this is a huge challenge.”

Shalabh Gupta further indicated, “Our drug, which uses nanoparticle technology, has been developed and tested in multiple animal models. Renazorb has been evaluated in Phase 1 clinical trials under U.S. Food and Drug Administration (FDA) guidance. Since the time Unicycive acquired the drug, we have held three FDA meetings and have been able to align with the Agency such that we only have to conduct one bioequivalence clinical trial to be able to file Renazorb for full approval with the U.S. FDA. Unicycive initiated that bioequivalence study in June of 2022 and we expect to complete it in the fourth quarter of 2022, with plans to file a New Drug Application for FDA approval in 2023.”

Shalabh Gupta said, addressing what people should recognize about their treatment for hyperphosphatemia, “One of the main attractions for Renazorb is that it provides an ideal phosphate lowering agent that can be taken three times daily in a small pill size that can be swallowed (not chewed) and provides patients with a treatment they can take for the rest of their lives.”

Lynn Fosse, Senior Editor
CEOCFO Magazine
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