Guard Therapeutics announced today that an independent Data Safety Monitoring Committee (DSMC) has completed its first planned review of safety data and has recommended that the Phase 2b clinical study POINTER continue as planned. The committee reviewed safety data from 67 patients, corresponding to more than one-third of the planned number of patients in the study, which evaluates the drug candidate RMC-035 as a kidney protective treatment in open-heart surgery.
Guard Therapeutics today announced the formation of a new Scientific Advisory Committee comprising seven globally recognized experts in nephrology and drug development. The committee will play a pivotal role in advising on the company’s late-phase development strategy and the design of the upcoming Phase 3 trial for RMC-035, a kidney protective therapy intended for use in open-heart surgery.
Guard Therapeutics today announced that it has reached the important milestone of enrolling 25% of its target in the phase 2b POINTER study. This trial is evaluating the kidney-protective effects of the investigational drug RMC-035 in patients undergoing open-heart surgery. The next major milestone will be the result of the first of two independent, blinded safety analyses, expected in the first quarter of 2025.
Guard Therapeutics International AB (publ) today announced that a Nomination Committee has been appointed in accordance with previous AGM resolutions.
Guard Therapeutics today announced that the first patient in Europe was dosed in the phase 2b POINTER study with the drug candidate RMC-035 as a kidney-protective treatment in open-heart surgery.
The board of directors of Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) today announces the outcome in the rights issue of shares (repair issue) announced on 27 August 2024 (the “Rights Issue”). The outcome shows that, in total, 227,922 shares were subscribed for by exercise of subscription rights, corresponding to approximately 8.5 per cent of the Rights Issue, and 10,968 shares were subscribed for without subscription rights, corresponding to approximately 0.4 per cent of the Rights Issue. The Rights Issue was thus subscribed to a total of approximately 8.9 per cent, and through the Rights Issue, the Company will receive approximately SEK 7.2 million before transaction costs.
Guard Therapeutics today announced that the renowned scientific journal eClinicalMedicine, part of Lancet Discovery Science, has published an article describing the main findings from the company's phase 2 clinical study AKITA with the drug candidate RMC-035, which is being evaluated for the treatment of kidney injury associated with open-heart surgery. The results form the basis for the continued clinical development program with RMC-035 and the design of the recently initiated phase 2b POINTER study.
Guard Therapeutics International AB (publ) (“Guard Therapeutics” or the “Company”) has, due to the Company’s upcoming rights issue of shares, that was announced on 27 August 2024 (the “Rights Issue”), prepared an EU Growth Prospectus (the “Prospectus”), which today has been approved and registered by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen).