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Unicycive Announces Acceptance of Multiple Datasets to Be Presented at the European Renal Association Congress

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Unicycive Therapeutics (Nasdaq: UNCY) announced that two datasets showcasing the safety and potential efficacy of UNI-494 in animal models will be presented at the 60th European Renal Association Congress (ERA 2023) in Milan, Italy, from June 15-18, 2023. The presentations include one on UNI-494's impact on rat respiratory function and another detailing its effect on lowering urinary b2-microglobulin levels. CEO Shalabh Gupta expressed optimism regarding the drug's reno-protective capabilities, particularly for treating acute kidney injury (AKI), a condition lacking FDA-approved therapies. Additionally, the company is developing Renazorb, a phosphate binding agent, with plans to file a New Drug Application (NDA) mid-year.

Positive
  • Acceptance of safety and efficacy data for UNI-494 for presentation at ERA 2023.
  • Potential reno-protective effect of UNI-494, addressing unmet needs in renal disease treatment.
  • Development of Renazorb with an expected NDA filing mid-year.
Negative
  • None.

Data highlights the potential safety and reno-protective effect of UNI-494

LOS ALTOS, Calif., April 24, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with unmet medical needs, today announced that two datasets highlighting the safety and suggestive efficacy of UNI-494 in animal models were accepted for oral presentation at the upcoming 60th European Renal Association Congress (ERA 2023) taking place from June 15-18, 2023, in Milan, Italy.

The following data will be presented at ERA 2023:

Title: UNI-494 Does Not Significantly Affect Rat Respiratory Function
Format: Focused Oral Presentation
Presenter: Shalabh Gupta, M.D., Chief Executive Officer of Unicycive

Title: UNI-494 Lowers Urinary b2-microglobulin Levels in Rats
Format: Moderated Oral Presentation
Presenter: Shalabh Gupta, M.D., Chief Executive Officer of Unicycive

“We are looking forward to the presentation of this growing body of evidence supporting the safety and suggestive clinical utility of UNI-494 to be reno-protective. There remains a great unmet need in renal diseases, and we believe UNI-494, with its novel mechanism of action that restores mitochondrial function, may be a promising therapy for acute kidney injury, a condition for which there are currently no approved treatments,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive, Inc.

About Unicycive Therapeutics

Unicycive is focused on two kidney diseases with large unmet medical needs. We are developing Renazorb, an investigational phosphate binding agent using proprietary nanoparticle technology for the treatment of patients with hyperphosphatemia. We plan to file a New Drug Application (NDA) for Renazorb with the U.S. Food and Drug Administration (FDA) mid-year. We are also developing UNI-494, a new chemical entity with a novel mechanism of action that restores mitochondrial function in acute and chronic diseases. Our initial target for UNI-494 is acute kidney injury (AKI), for which there are currently no FDA-approved medicines.

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 will be presented at the ERA 2023 by Unicycive Therapeutics?

Unicycive Therapeutics will present two datasets on UNI-494, focusing on its safety and potential efficacy in animal models.

What is UNI-494's potential use in medicine?

UNI-494 is being developed to treat acute kidney injury (AKI), a condition with no FDA-approved treatments.

When is the ERA 2023 Congress?

The ERA 2023 Congress will take place from June 15-18, 2023, in Milan, Italy.

What is the significance of UNI-494's presentations at ERA 2023?

The presentations will highlight UNI-494's safety data and suggestive efficacy, indicating its potential as a treatment for renal diseases.

What other product is Unicycive developing alongside UNI-494?

Unicycive is also developing Renazorb, an investigational phosphate binding agent, with plans to file an NDA mid-year.

Unicycive Therapeutics, Inc.

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