Interviewer Mark Roberts, Senior Editor at Traders News Source
Dr. Shalabh Gupta
CEO at Unicycive Therapeutics, Inc.
About Dr. Gupta
“A physician by training and background – found my passion in bringing new technologies to market – ultimately to help patients, physicians, and society. I find novel medicines, novel diagnostics, and novel healthcare technology solutions that are either underappreciated or are in the early stages of development and by bringing them to the world with the help of a team, investors, and other partners- we can truly make this world a better place.”
“My latest company, Unicycive was started in 2016, and starting from inception to licensing and building the company in a real way in 2018, the company went public in July 2021. Unicycive is developing novel treatments for kidney diseases.”
“Biocycive, my first company, was based on technology licensed from USC, focused on oncology, and was started in 2011. Sorrento Therapeutics acquired Biocycive for a total of $160MM, including upfront cash, milestones, and royalty payments in January 2015.”
“Globavir, my second company, was founded based on technologies from Stanford University – from labs of Dr. Vijay Pande and two other licenses for technologies from departments of Internal Medicine, and Clinical Virology to create a portfolio of drug and diagnostic tests for infectious diseases. In 2014, Globavir was selected as one of the companies to be part of the Stanford Start-X Med program. Globavir in 2017 partnered to out-license part of the diagnostic portfolio to Bio-Rad for global sales of diagnostic tests for infectious diseases.”
“Prior to my entrepreneurial role, I worked for Genentech in the commercial strategy group. At Genentech, I worked on several in-line drugs as well as pipeline drugs.”
“Earlier in my career, I was a practicing physician (NYU Medical Center) for a decade while also serving as medical director for biotech companies (Synageva – before Alexion acquired it), as an equity research analyst on Wall Street (Rodman & Renshaw, and UBS).”
“On Wall Street, I covered small to mid-cap biotech companies at Rodman & Renshaw (now HC Wainwright) and covered large-cap pharmaceutical companies at UBS including Pfizer, Merck, Wyeth, Schering Plough, and Bristol Myers Squibb. My work included financial modeling, potential M&A synergies, and initiation and launch of companies and new companies coming to US public markets.”
Dr. Gupta, thank you giving us your time to answer some questions. Can you give us a brief overview of your company’s business model and potential revenue streams?
“Unicycive is a clinical stage biotechnology company with two drugs in the pipeline. Renazorb, our lead drug, is indicated for treatment of patients with hyperphosphatemia. Renazorb has undergone one clinical trial (Phase 1) already and is currently being evaluated in a healthy volunteer bio-equivalence clinical trial. This is the only clinical trial required to file the drug for a New Drug Application (NDA). Renazorb is being developed under an abbreviated drug development pathway – called 505(b)(2) so Renazorb does not have to go through traditional Phase 1, 2 and then Phase 3 trials. The FDA has given this guidance and alignment during the last several FDA meetings.”
“The second drug, UNI-494 is a drug candidate that is focused on mitochondria. Mitochondria provide energy storage for the cells in the human body. If the energy storage does not work properly – the cell cannot function properly. UNI-494 works very selectively on the pores of these mitochondria to make them stable when the cells are under stressed conditions, such as inflammation. Since mitochondria are present throughout the body – this drug has potential application in more than one organ. For now, Unicyicve is considering the potential application of this drug in kidney, liver, eyes, and heart.”
What is Hyperphosphatemia, what are its complications, and how prevalent is it in the USA?
“Phosphate is an important ingredient in the body. It is present in bones and teeth and we all have it in order to have our body work properly. However, when a person has kidney dysfunction, they start to have difficulty in excreting phosphate, which is more than needed. Kidneys are filtering organs of the body and anything that is not needed or is in excess of normal quantity gets excreted by kidneys. In patients with kidney diseases of long duration, or Chronic Kidney Disease (CKD stage 3 and onward) the ability to excrete this phosphate is diminished. When phosphate starts to accumulate in the body, it causes severe problems that affect the heart and bones. Patients with hyperphosphatemia (high phosphate in their blood) end up with cardiac problems (including heart attacks in the later stages) and bone problems (fractures) and also are exposed to high rates of hospitalizations. In fact, when phosphate levels severely elevated, patients have twice the risk of death when compared to someone with controlled phosphate levels. In the U.S., there are nearly 40 million patients who suffer from CKD stage 3 and 4, with nearly half a million of those patients requiring dialysis (CKD stage 5). These late-stage patients almost always need a treatment for their hyperphosphatemia. With the global market for hyperphosphatemia treatments in excess of $2 billion, the opportunity for a new therapy with the enhanced product profile Renazorb offers in terms of convenience and potential compliance is substantial.”
Could you talk about phosphates in the diet, their impact on the kidneys, and how to avoid them?
“High phosphate content is present in most of protein-based diets and in particularly large quantities in frozen food. Unfortunately, many patients with CKD are on diets that include a lot of frozen food, especially frozen food with meat content, which is very rich in phosphate. That makes it really hard for these patients to manage their phosphate. And, then they need to be on phosphate lowering drugs.”
You’ve advised the beginning of a BE trial for Renazorb as a prelude to a 505(b)(2) NDA filing. How many subjects will participate in the trial, and can you estimate the time until trial completion?
“32 subjects in each arm, and they are given either Renazorb or Fosrenol ( a reference drug that is also based of Lanthanum) for three days. Then they are monitored for their urinary phosphate levels and then they are given a few days break (wash out period) and then whoever received Fosrenol, will be switched over to receive Renazorb and vice versa. Again, their urinary phosphate levels will be measured for three days. So, overall the study is short and from start to finish should take only several months.”
As you approach a Phase I human trial for UNI-494 in H2 this year, can you describe the parameters of that study and the anticipated endpoints?
“The goal of Phase 1 is to show that UNI-494 breaks down in the body into Nicorandil and linker. We also want to see the confirmation that linker breaks down in the body and nicorandil is released slowly as we have seen in the animal models.”
“The profile of nicorandil then allows us the opportunity to find the right dose to test in patients (in Phase 2/3 clinical trials).”
UNI-494 targets mitochondrial dysfunction with treatment possibilities beyond the kidneys. What is mitochondrial dysfunction?
“Most diseases in the human body are the result of a long duration of inflammation. Inflammation is a result of stress to the organ system. On a cellular level, that stress leads to something called oxidative stress and there are chemicals that are released that cause different types of problems.”
“Inflammation (stress) leads to the opening of pores in mitochondria called Mitochondria Permeability Transition Pores (MPTP). These MPTP pores only open in disease states, and when they open, they lead to calcium leakage inside mitochondria, which eventually leads mitcohondria to swell up and die. UNI-494 works on stabilizing these dysfunctional mitochondrial pores.”
Is it prudent to think that one day, there will be pharmacological solutions to kidney disease that could eliminate the need for dialysis?
“Like many diseases that affect humanity e.g. diabetes, Alzheimer’s and heart problems – scientists have been trying to find new medicines to cure these ailments. While it is possible that in the future we can completely eliminate them, it is more likely, at least in the next decade, that we can have potential treatments to either delay disease progression or perhaps start to bring back diseased organs to normal function at least in part (disease modifying). UNI-494 has shown to have potential to be a disease modifying agent in a variety of diseases of the kidney, liver, heart and eye.”
Would you describe your vision of growth for your company both in the near term and long term?
“In the near term, our company is fully focused on getting Renazorb through the FDA approval process and advancing UNI-494 in to clinical development. In the longer term, our goal is to advance our drugs to bring meaningful change to patients.”
We really appreciate your time Dr. Gupta, thank you for answering our questions.
The Traders News Team