Unicycive showcases an innovative product pipeline

Multiple data presentations Support the company’s pipeline of innovative product candidates aimed at improving the quality of life of patients with kidney disease

An Independently Hosted Panel of Key Opinion Leaders to Highlight the Potential of the Company’s Product Candidates in Hyperphosphatemia and Acute Kidney Injury

LOS ALTOS, Calif., Oct. 26, 2022 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced today that She will have a strong presence at the upcoming American Society of Nephrology (ASN) Kidney Week 2022 taking place November 3-6, 2022 in Orlando, Florida.

“We look forward to presenting the growing body of clinical evidence supporting our innovative product candidates to improve the treatment paradigm for patients with kidney disease at this international nephrology conference,” said Shalabh Gupta, MD, CEO of Unicyclive. Hyperphosphatemia continues to be a serious problem for patients with end-stage renal disease worldwide, especially since compliance with currently available phosphate binders is difficult and we believe the product profile of Renazorb can improve adherence. -494, our new drug candidate to reduce oxidative stress and restore mitochondrial function.

Renazorb is an advanced phosphate binding agent using proprietary nanoparticle technology under development for the treatment of hyperphosphatemia. Unicycive has completed a Renazorb student clinical trial in 32 healthy volunteers. In this study, Renazorb was poorly absorbed from the systemic circulation and was safe and well tolerated at doses up to 6000 mg/day. Renazorb significantly reduced urinary phosphate excretion and significantly increased faecal phosphate excretion at doses equal to and greater than 3000 mg/day.

UNI-494 is a mitochondrial ATP-sensitive potassium channel activator (mitoKATP) in development for the treatment of AKI. UNI-494 has been shown in preclinical models to improve tubular function in rat models with acute kidney injury and works by blocking the opening of mitochondrial permeability transition pores.

The following abstracts have been accepted for presentation at ASN Kidney Week:

Poster title: “Preclinical pharmacokinetics of a new nicorandil prodrug”
Session title: Pharmacology (PO1900)
Attach # 3760757
Date hour : Friday, November 4, 10:00 a.m. to 12:00 p.m. EST
Billboard #: FR-PO220
Poster title: “Lanthanum Dioxycarbonate Effectively Reduces Urinary Phosphate Excretion in Healthy Volunteers”
Session title: Vascular calcification, nephrolithiasis, bone (PO0402)
Attach # 3760842
Date hour : Saturday, November 5, 10:00 a.m. to 12:00 p.m. EST
Billboard #: SA-PO171

Additionally, Abstract No. 3764498, titled “Daily Medication Volume of Phosphate Binder Therapies,” has been accepted for publication in ASN 2022’s Abstract Supplemental.

All ASN Kidney Week 2022 summaries are available on the ASN website (www.asn-online.org/education/kidneyweek)

Also, Ed Arce, Managing Director and Senior Biotechnology Analyst at HC Wainwright & Co., will moderate a panel of key opinion leaders on November 4, 2022. The panel will feature Ravindra L. Mehta, MD and Stuart M. Sprague , DO, FASN in a discussion of new treatment options for kidney disease. The panel is an investor-by-invitation-only event. For those interested in participating in the roundtable, please contact [email protected] Additionally, the event will be archived on video and accessible in the Events section of the Unicive website.

About Key Opinion Leaders

Dr Mehta is Emeritus Professor of Medicine in the Department of Medicine at the University of California, San Diego, where he directs the Masters in Clinical Research program at UCSD. He is an internationally recognized expert in the field of acute kidney injury (ARI) and continuous renal replacement therapy (CRRT). He chairs the annual international AKI and CRRT conference in San Diego which is now in its 25th year. He chaired the International Society of Nephrology (ISN) committee on AKI, is a founding member of the Acute Dialysis Quality Initiative (ADQI) and the Acute Kidney Injury network (AKIN), member of the KDIGO Guidelines in AKI committee and was the director of the ISN 0 by 25 initiative to eliminate preventable ARI deaths by 2025. He coordinated and led several multinational efforts to determine the best approaches to managing ARI and CRRT. He has over 200 original research publications, 100 reviews and book chapters. He has served on the study section of the NIH NIDDK and on expert panels and editorial boards for the Journal of American Society of Nephrology, Kidney International, and CJASN. He was a member of the ISN program committee and contributed to the annual meetings of the American Society of Nephrology, the National Kidney Foundation and ISICEM. He coordinated the development of consensus recommendations, including the RIFLE and AKIN diagnostic and staging criteria for AKI. He has been recognized as one of the best doctors in San Diego and the United States for several years. In 2008 he was recognized by Indian American Nephrologists and in March 2009 he was elected a Fellow of the Royal College of Physicians in the UK. He was awarded the International Society of Nephrology (ISN) Bywaters Award for Lifetime Achievement in IRA in April 2011. He graduated MBBS (1976) from Government Medical School, Amritsar, India , as well as the MD (1979) and DM (1981) degrees from the Postgraduate Institute of Medical Education and Research, Chandigarh, India. He then completed a nephrology fellowship at the University of Rochester in Rochester New York and earned his board in internal medicine (1986) and nephrology (1988). He has been on the San Diego faculty since 1988.

Dr Sprague is currently Chief of the Division of Nephrology and Hypertension at NorthShore University Health System and Clinical Professor of Medicine at the University of Chicago Pritzker School of Medicine. Previously, he was a professor of medicine at Northwestern University. Dr. Sprague was also a recipient of a Fulbright Chair. Dr. Sprague is internationally recognized in the field of bone and mineral metabolism, having authored over 200 peer-reviewed articles and speaking at numerous national and international professional meetings. Dr. Sprague previously served as Chairman of the Medical Advisory Board of the National Kidney Foundation of Illinois, the ASN Education Committee, and the Programs Committee of the National Kidney Foundation and ASN. He is currently a member of the steering committee of the Global Bone and Mineral Initiative, an international scientific organization under the auspices of the National Kidney Foundation and the European Renal Association to assess the diagnosis and management of bone, mineral and cardiovascular diseases. in patients with chronic kidney disease.

He received his undergraduate and medical degrees from Michigan State University in East Lansing, completed his internal medicine training at Rush-Presbyterian-St. Luke’s Medical Center in Chicago, and completed a clinical and research fellowship in nephrology at the University of Chicago.

Dr. Sprague is a member of the editorial board of several leading nephrology journals, is a reviewer for the NIH, served as chair of the Technical Expert Panel on Mineral Metabolism for CMS, and is a scientific consultant to industry.

About Unicycive Therapeutics

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. For more information, visit www.unicycive.com.

Forward-looking statement

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as “anticipate”, “believe”, “expect”, “estimate”. ‘ and ‘intend’. ” or other similar words or expressions that relate to Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. Many factors could cause cause actual events to differ materially from those indicated by these forward-looking statements.These factors include, but are not limited to, clinical trials involving a long and expensive process with an uncertain outcome, and the results of studies and prior trials may not be predictive of future trial results; our clinical trials may be suspended or terminated due to unexpected side effects or other safety risks that may prevent approval of our product candidates; risks related business interruptions, including the COVID-19 coronavirus outbreak, which could seriously harm our business financial situation and increase our costs and expenses; reliance on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence on third parties; and risks related to the inability to obtain FDA clearances or approvals and non-compliance with FDA regulations. Actual results may differ materially from those indicated by these forward-looking statements due to a variety of important factors, including: uncertainties related to market conditions and other factors described in more detail in the section entitled “Risk Factors” of the annual report of Unicycive on Form 10-K for the fiscal year ended December 31, 2021 and other periodic reports filed with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or other.

Investor contacts:
[email protected]
(650) 900-5470

Anne-Marie Fields
Serious investor relations
[email protected]

SOURCE: Unicycive Therapeutics, Inc.

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