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.
Guard Therapeutics [GUARD] today announced that the first patient in the US has been dosed with study drug in the ongoing global Phase 2 clinical trial AKITA. The main study objective is to evaluate the kidney-protective effect of RMC-035 in patients who are at increased risk of developing acute kidney injury in connection with open heart surgery.
Guard Therapeutics [GUARD] today announced that 134 of the planned 268 patients have been dosed in the global randomized, double-blinded and placebo-controlled Phase 2 clinical trial (AKITA). The AKITA study has been designed to evaluate the kidney-protective effects of the investigational drug RMC-035 in conjunction with open heart surgery. An interim analysis will be conducted by an independent Data Monitoring Committee (DMC) who will provide a recommendation in April regarding the continuation of the study.
Guard Therapeutics today announces that the company has received a grant from the Chinese Patent Office (China National Intellectual Property Administration) for its patent application no. 201780018244.4 that protects the company's biological investigational drug RMC-035 as a product.
Guard Therapeutics International AB (publ) today announces that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
Guard Therapeutics today announces that the U.S. Food and Drug Administration (FDA) has granted RMC-035 (ROSgard) Fast Track designation for reducing the risk of an irreversible loss of kidney function, initiation of kidney replacement therapy or death following open-chest cardiac surgery in patients who are at increased risk for acute kidney injury. FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs aimed at treating serious conditions which have a large unmet medical need, with the goal to provide patients earlier access to such drugs.