Guard Therapeutics today announced that Health Canada has approved the company's application to include patients in Canada in its phase 2b clinical study of RMC-035 as a kidney protective treatment in open heart surgery.
Guard Therapeutics [GUARD], a biotechnology company specializing in kidney diseases, announced today that the company conducted a digital R&D Update on January 30, 2024. The presentation included an update on next development steps for the drug candidate RMC-035 and progress within the preclinical development platform of new peptides intended for chronic treatment. A recording of the presentation is available on the company's website.
Guard Therapeutics [GUARD], a biotechnology company specialized in kidney diseases, announced today that the company is organizing a digital R&D Update on January 30, 2024, from 14:00 to 15:30. The company will discuss the results of the completed Phase 2 AKITA study and the continued development plan for the company’s lead candidate RMC-035. New preclinical results from the company's peptide platform will also be presented. In addition to Guard Therapeutics CEO Tobias Agervald and Chief Medical Officer Michael Reusch, Dr. David Goldsmith, Adjunct Professor of Nephrology, King's College, London, will also participate and provide an external perspective on the AKITA results.
Guard Therapeutics [GUARD], a biotechnology company specializing in kidney diseases, today announced that the United States Food and Drug Administration (FDA) has provided positive feedback regarding the continued development of the company's leading drug candidate RMC-035 in open-heart surgery. The next developmental step includes a phase 2b study with the aim of identifying an optimal dosage of RMC-035. The phase 2b study is also expected to enable the most efficient design of a subsequent pivotal phase 3 study.
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.