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.