Guard Therapeutics (publ) today announced top-line results from the company’s Phase 2b POINTER study evaluating the investigational drug candidate RMC-035 as a kidney-protective therapy in patients undergoing open-heart surgery. The study did not meet its primary and key secondary efficacy endpoints.
Guard Therapeutics (publ) today announced that top-line results from the company’s Phase 2b POINTER study with the investigational drug candidate RMC-035 have been selected for oral presentation on November 6 as a Late-Breaking Clinical Trial at the scientific conference American Society of Nephrology (ASN) Kidney Week 2025 in Houston, TX, USA.
Guard Therapeutics (publ) today announced favorable efficacy results from additional analyses of the Phase 2a AKITA study with the investigational drug candidate RMC-035. The previously reported primary results demonstrated a robust improvement in kidney function following open-heart surgery. The new analyses strengthen these findings and show that RMC-035 provides kidney-protective benefits both in patients with and without acute kidney injury, and additionally reduces key biomarkers of kidney damage, including albuminuria, further supporting its kidney-protective potential. Selected results will be presented at the leading U.S. scientific conference ASN Kidney Week 2025.
Guard Therapeutics (publ) today announced that the last patient in its ongoing Phase 2b clinical trial, POINTER, has successfully completed the final scheduled follow-up visit 90 days after surgery (last patient last visit). The study is evaluating the company’s drug candidate, RMC-035, as a kidney-protective treatment for patients undergoing open-heart surgery.
Guard Therapeutics (publ) today announced that additional results from the Phase 2 AKITA study with the company’s drug candidate RMC-035 will be presented at the scientific conference Kidney Week 2025 organized by the American Society of Nephrology (ASN), in Houston, TX, USA. The new results are based on post hoc analyses of the previously completed and reported study and provide deeper insights into the potential of RMC-035 to preserve kidney function after open-heart surgery.
Guard Therapeutics (publ) today announced that the company will present at the following investor conferences ahead of the upcoming readout of the Phase 2b POINTER study:
The quarter marked a key milestone with the completion of patient recruitment for our Phase 2b POINTER study – ahead of schedule. The positive final safety review reinforces confidence in the trial, underscoring strong momentum and positioning us well for future value creation.
Guard Therapeutics (publ) today announced that the last patient has been successfully enrolled in the company’s ongoing Phase 2b clinical trial, POINTER, evaluating the drug candidate RMC-035 as a kidney-protective therapy in patients undergoing open-heart surgery.
Guard Therapeutics today announced that an independent Data Safety Monitoring Committee (DSMC) has completed the second and final planned review of safety data from the ongoing Phase 2b clinical trial, POINTER, which is evaluating the kidney-protective effects of the drug candidate RMC-035 in connection with open-heart surgery. The company has received a favourable and unanimous recommendation from the DSMC to proceed with the study as planned, as no safety concerns have been identified.
Guard Therapeutics (publ) today announced that the design of its ongoing Phase 2b clinical trial, POINTER, will be presented at the annual congress of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) in Vienna, Austria.