Guard Therapeutics announced today that, through the European application procedure, the company has received authorization from regulatory authorities and ethics committees in Spain, Germany, and the Czech Republic to include patients in the clinical Phase 2b study POINTER with the drug candidate RMC-035 as a kidney-protective treatment in open-heart surgery.
“We are very pleased with the swift and positive response from the relevant authorities, which means that all approvals required to start the study are now in place in the countries where the study is planned to be conducted,” said Guard Therapeutics CEO, Tobias Agervald.
In April, the federal Canadian institution Health Canada was the first authority to approve the company’s application to include patients in the POINTER study. Patient enrollment is expected to begin shortly at several investigational sites in Canada and in the coming months in Europe, and to continue for about a year.
The POINTER study is a randomized, double-blind, and placebo-controlled Phase 2b study of RMC-035 with the main purpose of establishing an optimal dosing regimen and precise target group for treatment prior to a pivotal Phase 3 study. The study is expected to include a total of approximately 160 patients distributed across two different dose arms of RMC-035 (60 mg and 30 mg) and a control arm (placebo). The study's primary endpoint is change in renal function (estimated glomerular filtration rate, eGFR) from study start to 90 days after surgery, which corresponds to the planned follow-up period of the study participants. Overall study results are expected to be available approximately 6 months after completion of patient recruitment.