Unicycive will showcase its portfolio of innovative product candidates at the 2022 American Society of Nephrology Kidney Week

Unicycive will showcase its portfolio of innovative product candidates at the 2022 American Society of Nephrology Kidney Week
Unicycive Therapeutics, Inc.

Unicycive Therapeutics, Inc.

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

Independently organized 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 it 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 showcasing the growing body of clinical evidence in support of our innovative product candidates to advance the treatment paradigm for kidney disease patients at this major international nephrology conference,” said Shalabh Gupta, MD, CEO of Unicycive. Hyperphosphatemia continues to be a serious problem for end-stage renal patients worldwide, particularly as compliance with currently available phosphate binders is challenging and where we believe Renazorb’s unique product profile may improve adherence. We look forward to sharing compelling preclinical data on UNI-494, our new drug candidate for reducing oxidative stress and restoring mitochondrial function.”

Renazorb is an advanced phosphate binding agent using proprietary nanoparticle technology that is being developed for the treatment of hyperphosphatemia. Unicycive has completed a clinical trial studying Renazorb in 32 healthy volunteers. In this study, Renazorb was minimally absorbed into the systemic circulation and was safe and well tolerated at doses up to 6,000 mg/day. Renazorb significantly reduced urinary phosphate excretion and significantly increased fecal phosphate excretion at doses of 3000 mg/day and above.

UNI-494 is a mitochondrial ATP-sensitive potassium channel (mitoKATP) activator that is in development for the treatment of AKI. UNI-494 has been shown in preclinical models to improve tubular function in rat models of 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)

Poster #

3760757

Date and Time:

Friday, November 4, 10:00 a.m. to 12:00 p.m. Eastern Time

Cardboard #:

FR-PO220

Poster Title:

“Lanthanum dioxycarbonate effectively reduces urinary phosphate excretion in healthy volunteers”

Session Title:

Vascular Calcification, Nephrolithiasis, Bone (PO0402)

Poster #

3760842

Date and Time:

Saturday, November 5, 10:00 a.m. to 12:00 p.m. Eastern Time

Cardboard #:

SA-PO171

Additionally, Abstract #3764498, which is titled “Daily Medication Volume of Phosphate Binding Therapies,” has been accepted for publication in the ASN Supplemental Abstract 2022.

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

Separately, Ed Arce, CEO and Senior Biotech Analyst at HC Wainwright & Co., will host 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 in kidney disease. The panel is an invitation-only event for investors. For those who are interested in participating in the discussion board, please contact ea@unicycle.com. In addition, the event will be archived on video and accessible on the Events section of the Unicycive website.

About key opinion leaders

Dr. Mehta is Professor Emeritus of Medicine in the Department of Medicine at the University of California, San Diego, where he directs the UCSD Clinical Research Master’s Program. He is an internationally recognized expert in the field of acute kidney injury (AKI) and continuous renal replacement therapies (CRRT). He chairs the annual AKI and CRRT International Conference in San Diego, now in its 25th year. Chaired the International Society of Nephrology (ISN) AKI Committee, is a founding member of the Acute Dialysis Quality Initiative (ADQI) and the Acute Kidney Injury Network (AKIN), committee member of the KDIGO Guidelines on AKI and served as director of the ISN 0 by 25 initiative to eliminate preventable deaths from AKI by 2025. He has coordinated and led several multinational efforts to determine the best approaches for managing AKI and CRRT. He has over 200 original research publications, 100 book reviews and chapters. He has served on the NIH NIDDK study section and special emphasis panels and on the editorial boards of the Journal of the American Society of Nephrology, Kidney International, and CJASN. He has been on the ISN program committee and has contributed to the annual meetings of the American Society of Nephrology, the National Kidney Foundation, and ISICEM. He has coordinated the development of consensus recommendations that include 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 US for several years. In 2008 he was recognized by the Indian American Nephrologists and in March 2009 he was elected to the UK Royal College of Physicians. He received the Bywaters Award from the International Society of Nephrology (ISN) for his lifetime achievement in AKI in April 2011. He received the MBBS degree (1976) from the Government Medical College, Amritsar, India, and the MD (1979) and DM (1981) degrees from the Postgraduate Institute of Medical Education and Research in Chandigarh, India. He subsequently completed a nephrology fellowship at the University of Rochester in Rochester New York and earned his boards in Internal Medicine (1986) and Nephrology (1988). He has been on the San Diego faculty since 1988.

Dr Sprague He currently serves as Chief of the Division of Nephrology and Hypertension at NorthShore University Health System and is a 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 has also received a Fulbright professorship. Dr. Sprague is internationally recognized in the field of bone and mineral metabolism, having authored over 200 peer-reviewed articles and has spoken at numerous national and international professional meetings. Dr. Sprague previously served as chairman of the National Kidney Foundation of Illinois Medical Advisory Board, the ASN Education Committee, and the National Kidney Foundation and ASN Program Committee. He is currently a member of the leadership 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 kidney disease. chronicle.

He earned 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 nephrology clinical and fellowship at the University of Chicago.

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

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company that develops new treatments for kidney diseases. Unicycive’s lead drug, Renazorb, is a new phosphate-binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a new patent-protected chemical entity in late preclinical development for the treatment of acute kidney injury. For more information please visit unicive.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. These statements can be identified by using words such as “anticipate”, “believe”, “forecast”, “estimate” and “intend”. or other similar terms or expressions that refer 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. There are various factors that could cause actual events to differ materially from those indicated in such forward-looking statements.These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and the results of previous studies and trials may not predict the results of future trials ; our clinical trials may be suspended or interrupted due to side effects Unexpected risks or other security risks that could prevent approval of our product candidates; risks related to business interruptions, including the COVID-19 coronavirus outbreak, which could seriously damage our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependency on third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of several important factors, including: uncertainties related to market conditions and other factors described in more detail in the section entitled “Risk Factors” in the Report Unicycive Annual Report on Form 10-K for the year ended December 31, 2021 and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statement contained in this press release speaks only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor contact:
ir@unicycle.com
(650) 900-5470

ana marie fields
Stern Investor Relations
annemarie.fields@sternir.com
212-362-1200

SOURCE: Unicycle Therapeutics, Inc.

Leave a Comment