Guard Therapeutics presents the Nomination Committee for 2024
Guard Therapeutics International AB (publ) today announces that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
Guard Therapeutics International AB (publ) today announces that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
Guard Therapeutics (GUARD), a biotechnology company specializing in kidney diseases, today announced that its late breaking clinical trial abstract has been selected for presentation at the American Society of Nephrology (ASN) Kidney Week in Philadelphia, Pennsylvania, in November 2023. The abstract includes results from the Phase 2 clinical study AKITA evaluating the company’s leading candidate drug RMC-035 as a kidney protective therapy in open-heart surgery.
Guard Therapeutics [GUARD], a biotechnology company specializing in kidney diseases, today announced further information regarding the development strategy for the investigational drug RMC-035. An advisory meeting with the U.S. Food and Drug Administration (FDA) will be requested to explore dose optimization and the framework for a future registrational trial for the prevention of kidney injury in open-heart surgery. The development strategy is based on the recent top-line results of the Phase 2 AKITA study, which demonstrated statistically significant and clinically relevant long-term kidney-protective effects of RMC-035 after open-heart surgery.
Guard Therapeutics [GUARD], a biotechnology company specializing in kidney diseases, announced today that the last patient's last visit (LPLV) in the clinical Phase 2 study AKITA has been completed. The study aims to evaluate the kidney protective effect of the investigational drug RMC-035 in relation to open heart surgery. This milestone means that all patients in the study have been followed up for 90 days after surgery. Top-line results from the study are expected to be communicated in the autumn of 2023 and will thus include the efficacy and safety of RMC-035 throughout the follow-up period.
Guard Therapeutics [GUARD], a biotechnology company specialized in kidney diseases, today announced the full results from the company's Phase 1b clinical study of the investigational drug RMC-035 in patients undergoing kidney transplantation. The study results confirm the previously positive preliminary data analysis and demonstrate favorable pharmacokinetic properties of RMC-035 without any serious adverse effects associated with the investigational drug.
Guard Therapeutics [GUARD] provides updated timelines and additional details on the plan for data analysis in the clinical phase 2 study AKITA, which aims to evaluate the kidney-protective effect of the investigational drug RMC-035 in connection with open heart surgery. The previously reported interim analysis focused on acute drug effects including the incidence of acute kidney injury within 72 hours after surgery. Data collection and analysis for evaluation of efficacy continues for the planned 90-day period for subjects in the study.
Guard Therapeutics [GUARD] today announces that an external and independent Data Monitoring Committee (DMC) recommends termination of the ongoing phase 2 clinical trial AKITA. The recommendation is based on a planned interim analysis regarding both efficacy and safety of the investigational drug RMC-035 using data from half of the total planned 268 patients.
Guard Therapeutics [GUARD] today announced positive results of the company's phase 1b clinical trial of the investigational drug RMC-035 in patients undergoing kidney transplantation. The study met its primary objective and demonstrated good pharmacokinetic properties of RMC-035 in this patient population and a favorable safety profile.
Guard Therapeutics [GUARD] today announced that the results from its Phase 1b clinical trial of RMC-035 in patients undergoing open heart surgery have been published in the scientific journal Kidney International Reports. The Phase 1b study met its primary objective and has formed the basis for the company's ongoing Phase 2 clinical trial AKITA.