Guard Therapeutics presents the Nomination Committee for 2024
Guard Therapeutics International AB (publ) today announces that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
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.
Guard Therapeutics [GUARD] provides updated timelines and additional details on the plan for data analysis in the clinical phase 2 study AKITA, which aims to evaluate the kidney-protective effect of the investigational drug RMC-035 in connection with open heart surgery. The previously reported interim analysis focused on acute drug effects including the incidence of acute kidney injury within 72 hours after surgery. Data collection and analysis for evaluation of efficacy continues for the planned 90-day period for subjects in the study.
Guard Therapeutics [GUARD] today announces that an external and independent Data Monitoring Committee (DMC) recommends termination of the ongoing phase 2 clinical trial AKITA. The recommendation is based on a planned interim analysis regarding both efficacy and safety of the investigational drug RMC-035 using data from half of the total planned 268 patients.
Guard Therapeutics [GUARD] today announced positive results of the company's phase 1b clinical trial of the investigational drug RMC-035 in patients undergoing kidney transplantation. The study met its primary objective and demonstrated good pharmacokinetic properties of RMC-035 in this patient population and a favorable safety profile.
Guard Therapeutics [GUARD] today announced that the results from its Phase 1b clinical trial of RMC-035 in patients undergoing open heart surgery have been published in the scientific journal Kidney International Reports. The Phase 1b study met its primary objective and has formed the basis for the company's ongoing Phase 2 clinical trial AKITA.
Guard Therapeutics [GUARD] today announced that the first patient in the US has been dosed with study drug in the ongoing global Phase 2 clinical trial AKITA. The main study objective is to evaluate the kidney-protective effect of RMC-035 in patients who are at increased risk of developing acute kidney injury in connection with open heart surgery.
Guard Therapeutics [GUARD] today announced that 134 of the planned 268 patients have been dosed in the global randomized, double-blinded and placebo-controlled Phase 2 clinical trial (AKITA). The AKITA study has been designed to evaluate the kidney-protective effects of the investigational drug RMC-035 in conjunction with open heart surgery. An interim analysis will be conducted by an independent Data Monitoring Committee (DMC) who will provide a recommendation in April regarding the continuation of the study.
Guard Therapeutics today announces that the company has received a grant from the Chinese Patent Office (China National Intellectual Property Administration) for its patent application no. 201780018244.4 that protects the company's biological investigational drug RMC-035 as a product.
Guard Therapeutics International AB (publ) today announces that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
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.
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.
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 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.
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.
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 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.
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.
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.
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”).
Guard Therapeutics today reports positive results from preclinical studies of the company’s investigational drug ROSgard in experimental animal models of sepsis. Two independent studies conducted at the Karolinska Institute show that ROSgard reduces the harmful effects that occur in both the liver and kidneys when these organs are exposed to a general inflammation and oxidative stress.
The Board of Directors of Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) has, in connection with the Company's upcoming rights issue that was announced on 20 October 2021 (the “Rights Issue”), prepared an EU Growth Prospectus (the “Prospectus”), which today has been approved and registered by the Swedish Financial Supervisory Authority.
Guard Therapeutics today presents positive results from a clinical phase 1b study of the potentially kidney-protecting biological investigational drug ROSgard in connection with open heart surgery. The study fulfilled its primary objective – to confirm ROSgard’s favourable safety and tolerability profile in the patient population for which treatment is initially intended. In addition, explorative analyses of several well-established biomarkers indicate that ROSgard potentially has the ability to protect kidney cells from injury associated with heart surgery. The company is now continuing its preparations for a comprehensive clinical phase 2 study.
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 company has received an Intention to Grant notice from the European Patent Office (EPO) for a patent application concerning its biological investigational drug ROSgard as a product, including its medical use. The next step in the process is a formal EPO approval, which provides a patent protection until 2037.
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 today announces that Sara Thuresson has been recruited to a newly created position as Head of Clinical Operations. She held a similar position at Oncopeptides before joining Guard Therapeutics and will take up her new post on 24 May 2021.
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 announces that the company has completed a pre-IND meeting with the US Food and Drug Administration and has received positive feedback on its planned clinical development programme for its investigational drug ROSgard. This is an important validation of the quality of the project and is a significant step towards an application to include American study centres in future clinical studies (Investigational New Drug Application, IND).
Guard Therapeutics today announces that Ann-Kristin Myde has been appointed new Head of Global Project Management for the company. She will take up her post on 1 April 2021.
Guard Therapeutics AB (publ.) today announces that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for company’s patent application 16/085,500 directed to the biological investigational drug ROSgard as product (composition of matter). A formal approval is expected shortly, and if granted the patent is valid until 2037. The Notice of Allowance further strengthens Guard Therapeutics' patent portfolio and improves market exclusivity for ROSgard in one of the company’s key markets.
Guard Therapeutics today announced positive top-line results from a phase 1 study of its investigational drug ROSgard in individuals with renal impairment. The main aim of the study was to characterize the pharmacokinetic properties and safety profile of ROSgard in patients with renal impairment. The company believes that these results, together with previously reported positive results from a clinical phase 1 programme in healthy subjects, provide an excellent foundation for continued development of ROSgard in the area of acute kidney injury.
Guard Therapeutics today announced positive top line results from the concluding study in the clinical phase 1 programme in healthy subjects where the investigational drug ROSgard was administered in multiple ascending doses (MAD). ROSgard demonstrated good pharmacokinetic properties and a favourable safety profile. The company considers that this provides excellent conditions for continued development of the investigational drug within the field of acute kidney damage and is thus intensifying preparations in advance of forthcoming global patient studies.
Guard Therapeutics (Nasdaq First North Growth Market: GUARD) has today presented follow-up results from a previously completed phase 1 study of ROSgard in single ascending doses (SAD). In particular, the results show that the investigational drug has a favourable effect on a well established biomarker that is used to predict onset of acute kidney injury after cardiac surgery. The study was conducted in healthy subjects.
Guard Therapeutics has today announced that Peter Gilmour has been appointed Head of Preclinical Science. He has extensive experience in drug discovery and clinical drug development from leading positions at global pharmaceutical companies. Peter Gilmour will be part of the company’s management team and will take up his post on 1 August 2020.
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).
A1M Pharma today announced that the results from the initial part of a phase 1a study show that the investigational drug ROSgard™ has a good safety profile and that plasma concentrations that are expected to have a therapeutic effect were achieved. ROSgard is being developed as a potential new treatment for prevention of acute kidney injury in cardiac surgery.