Unicycive Announces Acceptance of Three Abstracts for Presentation at the National Kidney Foundation’s Spring Clinical Meetings

Rhea-AI Summary

Unicycive Therapeutics (Nasdaq: UNCY) announced the acceptance of three abstracts for presentation at the National Kidney Foundation's Spring Clinical Meetings, scheduled for April 11-15, 2023, in Austin, Texas. These abstracts highlight key findings involving UNI-494 and its potential for treating acute kidney disease, along with efficacy data underscoring Renazorb’s benefits as a phosphate binder for hyperphosphatemia. CEO Shalabh Gupta expressed optimism regarding the evidence supporting both products, particularly noting an upcoming FDA New Drug Application submission for Renazorb in mid-2023, enhancing its profile for chronic kidney disease patients.

Positive

• Three abstracts focusing on UNI-494 and Renazorb accepted for the National Kidney Foundation's Spring Clinical Meetings.
• Positive data presented for UNI-494, indicating low risk of drug interactions.
• Successful bioequivalence study of Renazorb compared to Fosrenol, supporting its application for FDA approval.
• Expected FDA New Drug Application filing for Renazorb in mid-2023.

Negative

• None.

Data support UNI-494’s potential to treat acute kidney disease and underscore the phosphate binding benefits of Renazorb as a potential treatment for hyperphosphatemia

LOS ALTOS, Calif., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that three abstracts have been accepted for presentation at the National Kidney Foundation’s (NFK) upcoming Spring Clinical Meetings taking place in Austin, Texas from April 11-15, 2023.

The following data will be presented at the NFK’s Spring Clinical Meeting:

• Results from three pre-clinical studies of UNI-494, evaluating the risk of drug/drug interactions (DDI) will be presented in a poster titled, “In Vitro Drug Interaction Studies of UNI-494 Indicate Low Risk of Drug-Drug Interactions.”
  
• Efficacy data from a study of UNI-494 in a bilateral renal ischemia perfusion (I/R) model will be presented in a poster titled, “UNI-494 Lowers Urine 2-microglobulin in Rats.”
  
• Outcomes from a study that evaluated the medication weight of various phosphate binders to bind 1 gram of phosphorus will be presented in a poster titled “Binder Weight to Bind 1 Gram of Phosphate.”
  

“We continue to build on the growing body of clinical evidence that supports the therapeutic potential of our two lead programs in kidney diseases and are delighted to be presenting these positive data before an audience of leading kidney disease experts,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive Therapeutics. “With the recently announced results of our successful bioequivalence study of Renazorb compared to Fosrenol®, we expect to file a New Drug Application with the U.S. Food and Drug Administration (FDA) 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 chronic kidney disease patients with hyperphosphatemia.”

“We are very encouraged by the UNI-494 data to be presented as it should underscore the prodrug’s potential to be reno-protective and to have low risk of DDI, both of which are important findings for this product candidate as a promising therapeutic for acute kidney disease, a condition for which there are currently no FDA approved therapies,” 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.

FAQ

What did Unicycive Therapeutics announce on January 23, 2023?

Unicycive announced the acceptance of three abstracts for presentation at the National Kidney Foundation's Spring Clinical Meetings.

What is UNI-494's potential according to Unicycive's latest updates?

UNI-494 shows potential for treating acute kidney disease with low drug interaction risks.

When is Unicycive's FDA New Drug Application for Renazorb expected?

The FDA New Drug Application for Renazorb is expected to be filed in mid-2023.

What are the benefits of Renazorb highlighted in the recent press release?

Renazorb is noted for its efficacy as a phosphate binder for hyperphosphatemia and aims to improve medication compliance.