29 Dec 2020
· Regulatory information
Guard Therapeutics completes successful pre-IND meeting with FDA
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).
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28 Dec 2020
· Regulatory information
Guard Therapeutics appoints Ann-Kristin Myde as Head of Global Project Management
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.
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11 Dec 2020
· Regulatory information
Guard Therapeutics receives Notice of Allowance from USPTO for ROSgard
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.
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28 Sep 2020
· Regulatory information
Guard Therapeutics reports positive top-line results from phase 1 study of ROSgard in individuals with renal impairment
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.
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06 Aug 2020
· Regulatory information
Guard Therapeutics announces positive top line results from the concluding study in the clinical phase 1 programme of ROSgard in healthy subjects
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.
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08 Jul 2020
· Regulatory information
Guard Therapeutics presents positive follow-up analysis from phase 1 study of ROSgard
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.
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06 Jul 2020
· Regulatory information
Guard Therapeutics appoints Peter Gilmour as Head of Preclinical Science
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.
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17 Mar 2020
Guard Therapeutics announces positive top line results from a clinical phase 1a study of ROSgard
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).
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19 Sep 2019
· Regulatory information
A1M Pharma announces positive top-line results from a phase 1a study of ROSgard
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.
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