Business
Unicycive Announces Second Quarter 2023 Financial Results and Provides Business Update
Recent Data Publications Highlight the Benefits of Oxylanthanum Carbonate (OLC) to Improve Medication Adherence and Quality of Life for Patients with Chronic
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Recent Data Publications Highlight the Benefits of Oxylanthanum Carbonate (OLC) to Improve Medication Adherence and Quality of Life for Patients with Chronic Kidney Disease Feedback from FDA Expected in Fall 2023 for OLC Program UNI-494 Phase 1 Trial Progressing as Planned with IND Application Expected in 2024 LOS ALTOS, Calif., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the second quarter ended June 30, 2023, and provided a business update. “Data publications and presentations continue to highlight the benefits of both our lead asset, Oxylanthanum Carbonate (OLC), and UNI-494 targeting treatment for patients with life threatening kidney diseases,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “For OLC, we expect to gain alignment with the U.S. Food and Drug Administration in the Fall of this year around the additional data requirements to advance the program towards submission of a New Drug Application. As we reported last month, recently published data demonstrated that OLC has the potential to improve medication adherence and the quality of life for patients suffering from chronic kidney disease. This reinforces our commitment to bring this important new treatment option to patients as soon as possible.” “Preclinical data from UNI-494 presented this quarter highlighted its novel mechanism of action to restore mitochondrial function. Importantly, the data showed UNI-494 was well tolerated and may protect the kidney against harmful effects related to acute kidney injury, a condition for which there are currently no approved treatments. Our Phase 1 study is ongoing in the United Kingdom, and as we reported previously, we are continuing with the healthy volunteer dosing. Concurrently, we plan to request a pre-IND meeting with the FDA before the end of this year to prepare to conduct further clinical studies in the U.S. in 2024,” concluded Dr. Gupta. Key Highlights The American Journal of Nephrology published positive results on the phosphate binding capacity for OLC showing that OLC had the lowest daily phosphate binder dose volume and the lowest volume required to bind one gram of phosphate compared to five othe...