Unicycive Announces Acceptance of Four Abstracts for Presentation at the World Congress of Nephrology 2023
Unicycive Therapeutics (Nasdaq: UNCY) announced the acceptance of four abstracts for presentation at the World Congress of Nephrology 2023 in Bangkok from March 30 – April 2. Key presentations will include data on Renazorb's phosphate binding capabilities from a Phase 1 clinical study and preclinical assessments of UNI-494. The company is optimistic about filing a New Drug Application for Renazorb with the FDA mid-2023, which could enhance its market position and partnership opportunities.
- Four abstracts accepted for presentation, showcasing Renazorb and UNI-494's capabilities.
- Upcoming FDA New Drug Application for Renazorb expected to improve market positioning.
- Successful Phase 1 study supporting Renazorb's phosphate binding ability.
- Potential for increased awareness and partnerships following international presentation.
- None.
Growing body of clinical evidence support the potential of Renazorb and UNI-494 to effectively treat hyperphosphatemia and acute kidney disease, respectively
LOS ALTOS, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that four abstracts have been accepted for presentation at the upcoming International Society of Nephrology’s World Congress of Nephrology 2023 meeting taking place in Bangkok, Thailand from March 30 – April 2, 2023.
The following data will be presented at ISN’s WCN:
- Data highlighting Renazorb’s novel phosphate binding ability from a Phase 1 clinical study will be presented in a poster titled, “Lanthanum Dioxycarbonate Effectively Reduces Urinary Phosphate Excretion in Healthy Volunteers.”
- Preclinical animal data evaluating Renazorb’s ability to reduce urine phosphate levels will be reviewed in a poster titled, “In-Vivo Phosphate Reduction: Lanthanum Dioxycarbonate vs Lanthanum Carbonate Tetrahydrate.”
- Outcomes from a study that evaluated the daily medication volume of various phosphate binders to determine the option with the lowest required daily volume will be presented in a poster titled, “Daily Medication Volume of Phosphate Binder Therapies.”
- Preclinical data from a dog study that analyzed systemic exposure to UNI-494 and nicorandil will be presented in a poster titled, “Preclinical Pharmacokinetics of a Novel Nicorandil Prodrug.”
“We are delighted to be presenting this bolus of data in support of both Renazorb and UNI-494 as potential treatment advances in hyperphosphatemia and acute kidney injury, respectively,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics. “With our recently announced successful bioequivalence study of Renazorb compared to Fosrenol®, we are looking forward to filing a New Drug Application with the U.S. Food and Drug Administration in mid-2023. These data provide further evidence of the benefits of Renazorb as a powerful phosphate binder and highlight its enhanced product profile, which is expected to improve medication compliance and, thereby, improve outcomes and quality-of-life for patients.”
“The exposure of these favorable data before an audience of international nephrologists should further expand awareness of the advantages of Renazorb to treat hyperphosphatemia and should bolster our positioning in any potential partnership or licensing discussions,” added Dr. Gupta.
Fosrenol is a registered trademark of Shire International Licensing BV.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug, Renazorb, is a novel 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, please visit www.unicycive.com.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern 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 several factors that could cause actual events to differ materially from those indicated by 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 results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon 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 various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s 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 statements contained in this press release speak 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@unicycive.com
(650) 900-5470
Anne Marie Fields
Stern Investor Relations
annemarie.fields@sternir.com
212-362-1200
SOURCE: Unicycive Therapeutics, Inc.
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