Guard Therapeutics 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. All eight patients in the study received treatment with RMC-035.

The open-label study without a control arm aimed to evaluate the pharmacokinetics and safety of RMC-035 in the context of kidney transplantation. RMC-035 was administered once daily for five days, with a total of five doses, within the dosage range of 0.3 to 0.6 mg/kg. The first dose was administered during the surgical procedure, i.e., the kidney transplantation itself.

In parallel, a global Phase 2 study (AKITA) is underway to evaluate the kidney-protective effect of RMC-035 in patients undergoing open-heart surgery. Top-line results from the AKITA study are expected to be available during the autumn in 2023 and will form the basis for the continued clinical development of RMC-035 in both heart surgery and kidney transplantation.