14 Jul 2023
Last patient visit completed in Guard Therapeutics' clinical Phase 2 study AKITA
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.
Read more
14 Jun 2023
Study results with Guard Therapeutics’ RMC-035 in kidney transplantation confirm previously positive data analysis
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.
Read more
02 May 2023
Guard Therapeutics provides updated information on the phase 2 study AKITA
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.
Read more
14 Apr 2023
· Regulatory information
Guard Therapeutics closes its phase 2 clinical trial AKITA following DMC recommendation
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.
Read more
16 Mar 2023
Guard Therapeutics presents positive clinical data with RMC-035 in patients undergoing kidney transplantation
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.
Read more
20 Feb 2023
Results from Guard Therapeutics' Phase 1b study in cardiac surgery published in Kidney International Reports
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.
Read more
16 Feb 2023
First US patient dosed in Guard Therapeutic’s Phase 2 AKITA study
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.
Read more
10 Feb 2023
Half of the patients dosed in the Phase 2 AKITA study
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.
Read more
09 Jan 2023
· Regulatory information
Guard Therapeutics receives patent approval for RMC-035 in China
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.
Read more
20 Dec 2022
· Regulatory information
Guard Therapeutics presents the Nomination Committee for 2023
Guard Therapeutics International AB (publ) today announces that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
Read more