08 Nov 2022
· Regulatory information
Guard Therapeutics granted FDA Fast Track designation for RMC-035
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.
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10 Oct 2022
· Regulatory information
Guard Therapeutics receives IND approval from the FDA for RMC-035
Guard Therapeutics today announces that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for the investigational drug RMC-035 (ROSgard). The approval enables expansion of the clinical development program for RMC-035 to the US, including the ongoing global and placebo-controlled Phase 2 study AKITA in cardiac surgery.
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23 Sep 2022
Presentations from Guard Therapeutics' Capital Markets Day are now available on the company's website
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.
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05 Sep 2022
First kidney transplant recipient dosed with Guard Therapeutics' investigational drug RMC-035
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.
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19 Aug 2022
Guard Therapeutics hosts capital markets day
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.
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01 Jun 2022
· Regulatory information
Guard Therapeutics receives approval from the Swedish Medical Products Agency to conduct a clinical study of RMC-035 in kidney transplantation
Guard Therapeutics today announces that the company has received approval from the Swedish Medical Products Agency (MPA) to start a clinical phase 1b study with the investigational drug RMC-035 (ROSgard) in patients undergoing kidney transplantation. Through the planned study, the company is thus expanding the clinical development program of RMC-035 into a second indication with significant need for kidney protective treatments. The study will include up to 12 individuals with the primary objective to evaluate the pharmacokinetic properties of RMC-035 in this patient population. The company is expected to present full study results in the first half of 2023.
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26 Apr 2022
· Regulatory information
Guard Therapeutics recruits new Head of CMC
Guard Therapeutics announces that the company has appointed Torbjörn Larsson as Head of CMC (Chemistry, Manufacturing and Controls). Torbjörn Larsson will join the management team and will report directly to the CEO.
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13 Apr 2022
Guard Therapeutics provides in-depth information on phase 2 clinical trial
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.
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07 Apr 2022
First patient has been dosed in Guard Therapeutics' Phase 2 clinical trial of ROSgard
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.
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12 Jan 2022
Guard Therapeutics receives approval to expand the global phase 2 study of ROSgard to Canada
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.
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