Press releases


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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05 Jan 2022

Guard Therapeutics’ application to conduct a phase 2 clinical trial of ROSgard is 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.

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15 Dec 2021  ·  Regulatory information

Guard Therapeutics appoints Michael Reusch as Chief Medical Officer

Guard Therapeutics announces today that the company has appointed Dr. Michael Reusch as Chief Medical Officer. Dr. Reusch has over 30 years’ experience in global clinical development and regulatory processes from leading positions in the pharmaceutical industry, most recently in the role of Senior Medical Director at Astellas Pharma. He will take up his new position on 1 January 2022.

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03 Dec 2021  ·  Regulatory information

Guard Therapeutics announces final result of rights issue

The final result of the rights issue that was announced on 20 October 2021 and where the subscription period ended on 29 November 2021 (the “Rights Issue”) in Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”), shows that the Rights Issue was subscribed to approximately 41 percent. The remaining approximately 59 percent of the Rights Issue was subscribed for by Rutger Arnhult, through M2 Asset Management AB, and Jan Ståhlberg in accordance with given declarations of intention to subscribe. As a result of the Rights Issue, Guard Therapeutics will receive proceeds amounting to approximately SEK 128 million before issue costs.

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02 Dec 2021  ·  Regulatory information

Guard Therapeutics announces preliminary result of rights issue

The preliminary result of the rights issue that was announced on 20 October 2021 and where the subscription period ended on 29 November 2021 (the “Rights Issue”) in Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”), shows that the Rights Issue was subscribed to approximately 41 percent. The remaining approximately 59 percent of the Rights Issue is subscribed for by Rutger Arnhult, through M2 Asset Management AB, and Jan Ståhlberg in accordance with given declarations of intention to subscribe. As a result of the Rights Issue, Guard Therapeutics will receive proceeds amounting to approximately SEK 128 million before issue costs.

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24 Nov 2021  ·  Regulatory information

Guard Therapeutics publishes supplementary prospectus

Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) has prepared a supplementary prospectus (the “Supplementary Prospectus”) to the prospectus that was approved and registered by the Swedish Financial Supervisory Authority (the “SFSA”), and published on 10 November 2021 (the “Prospectus”).

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We are dedicated to developing tomorrow’s drugs against oxidative stress, helping millions of people to a better life by preventing and treating serious kidney diseases. ROSgard, our biological drug candidate, mimics the body’s own powerful defense system against oxidative stress. Designed with a natural “homing” to the kidneys, ROSgard prevents kidney damage by protecting, cleaning and repairing the exposed cells and tissues.

Mail Address

Guard Therapeutics AB
Box 5216
102 45 Stockholm, Sweden

Visiting Address

Guard Therapeutics
Nybrogatan 34, 2 tr
114 39 Stockholm, Sweden

Telephone

+46 (0)8 670 65 51

E-mail

info@guardtherapeutics.com