Unicycive Therapeutics issues letter to shareholders

Unicycive Therapeutics issued a letter to shareholders. “In this letter, I am pleased to recap for you another year of great accomplishments. We’ve made significant advancements in our clinical programs which will propel us to new heights in 2024. Addressing a Critical Need… Our lead program, Oxylanthanum Carbonate, or OLC, is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology with two key advantages. First, only three tablets are required per day. Second, the tablets are swallowed whole with water and not chewed, making it easier for patients to take.During 2023 we made significant progress with OLC under the FDA’s 505(b)(2) regulatory pathway which allows us to reference the already approved drug, lanthanum carbonate to streamline our submission package. As reported in December 2022, OLC was evaluated in a previous bioequivalence study that measured efficacy in healthy volunteers in which OLC has found to be equivalent to the reference drug, Fosrenol… Strong Scientific Leadership with OLC. This year we continued to publish scientific data on OLC at national and international conferences. We presented five posters on OLC at conferences including at the National Kidney Foundation, International Society of Nephrology and European Renal Association… Increasing Market Awareness. A top priority for us in 2023 was growing market awareness of OLC’s potential best-in-class product profile. We conducted live and virtual advisory board meetings with some of the country’s most influential nephrologists… We are encouraged by the overwhelmingly positive reception to the OLC story and are planning continued market-shaping activities for 2024. Portfolio Expansion. In addition to OLC, we continue to advance our second compound UNI-494 for the treatment of acute kidney injury and chronic kidney disease… UNI-494 is protected by issued patents in the U.S. and Europe and a wide range of patent applications worldwide…We believe 2024 will be a transformational year for Unicycive. We will report out our pivotal data for OLC next quarter and plan to complete our data package and submit an NDA mid-year. We continue to work closely with the medical community to publish data on our programs and plan for future commercialization of OLC. “