On September 21, 2022, Guard Therapeutics hosted a Capital Markets Day at Erik Penser Bank in Stockholm to provide an update on the company's development projects and the clinical strategy for the investigational drug RMC-035 (ROSgard). The presentations were recorded and are now available on the company's website.
Guard Therapeutics today announces that the first patient has been dosed in a Phase 1b clinical trial of the investigational drug RMC-035 (ROSgard) in kidney transplantation. The company has thus achieved an important milestone by expanding the clinical development program to a second indication where RMC-035 has the potential to protect against acute kidney injuries. Full study results are expected to be available in the first half of 2023.
Guard Therapeutics invites current and potential investors to a capital markets day where the company will inform the audience on main development projects and clinical strategy for the investigational drug RMC-035 (ROSgard). The event will take place on September 21, 2022, 12:00 p.m. CET, at Erik Penser Bank in Stockholm and will be streamed live.
Guard Therapeutics today provides an update on the plan for the company's global, clinical phase 2 study of ROSgard in patients undergoing open heart surgery with additional risk factors to develop acute kidney injury. The study aims to evaluate the renal protective treatment effect of ROSgard based on several outcome measures, and is anticipated to provide a comprehensive data set to support further clinical development including the design of a subsequent registration study. The phase 2 study is called AKITA and is expected to provide blinded interim results in the first quarter of 2023 at topline results during the later part of 2023. Guard Therapeutics CEO, Tobias Agervald, presents the study design in a video interview that is available via link further down in this press release.
Guard Therapeutics today announces that the first patient has been dosed in the company's global phase 2 clinical trial of ROSgard. The study is conducted in patients who undergo open heart surgery and thus are at risk of developing acute kidney injury. The results are expected to provide conclusive information on the treatment effect of the investigational drug in this patient group and to guide the design of a subsequent pivotal study.
Guard Therapeutics today announces that the Canadian health authority (Health Canada) has approved the company’s application to conduct and include patients in Canada in the comprehensive phase 2 study of ROSgard, an investigational drug being developed for the prevention and treatment of acute kidney injury. This global study is planned to be conducted in Europe and North America and has since earlier been approved by the German medicines regulator.
Guard Therapeutics announces today that the German medicines regulator, the Federal Institute for Drugs and Medical Devices (BfArM), has approved the company’s application to conduct a comprehensive clinical phase 2 study of ROSgard, an investigational drug being developed for the prevention and treatment of acute kidney injury. The global study is planned to be conducted in Europe and North America under the guidance of Prof. Dr. Alexander Zarbock at Münster University Hospital, Germany.
Guard Therapeutics AB (publ.) announces that the European Patent Office (EPO) today has granted a patent for the company’s biological investigational drug ROSgard, both as a product and for its medical use. The patent provides protection in Europe until 2037.
Guard Therapeutics announces today that all 12 patients have been included in the company’s clinical phase 1b study of ROSgard, which is being conducted in people undergoing open heart surgery who have additional risk factors for acute kidney injury. The study is being conducted at the University Hospital in Münster, Germany. Top-line results are expected to be presented in September 2021.
Guard Therapeutics today announces that the company has established an external Scientific Advisory Committee (SAC) initially consisting of five global experts. The committee’s main task in the near future will be to contribute their expertise in the final design of the planned phase 2 study of the company’s investigational drug ROSgard in patients undergoing cardiac surgery.
Guard Therapeutics AB (publ.) today announces that the United States Patent and Trademark Office (USPTO) has granted the company’s patent application no. 16/085,500 directed to the biological investigational drug ROSgard as product (composition of matter). The granted patent follows the Notice of Allowance that was issued and communicated in December 2020.
Guard Therapeutics today announces that the first patient has been dosed in a phase 1b study of the company’s investigational drug ROSgard. The study is being conducted in patients undergoing open heart surgery who have additional risk factors for acute kidney injury. The phase 1b study is being conducted at Münster University Hospital in Germany.
Guard Therapeutics has obtained patent protection in Australia for their biological investigational drug ROSgard, both as product and for its use in medicine.
Guard Therapeutics today announced positive top line results from the final and highest dosage group as part of a clinical phase 1a study where single ascending doses (SAD) of the investigational drug ROSgard™ were administered to healthy subjects. ROSgard also demonstrated good pharmacokinetic properties and a favourable safety profile at this dosage level, which is higher than the one that is expected to be used in future patient studies. The next stage in the phase 1a programme is to study ROSgard in multiple ascending doses (MAD).