Press release

25 Mar 2025

Two-thirds of patients enrolled in Guard Therapeutics' Phase 2b POINTER study

Guard Therapeutics announced today that it has reached another key milestone in its ongoing clinical development program. Two-thirds of the approximately 160 planned patients have now been enrolled in the Phase 2b POINTER study, which is evaluating the drug candidate RMC-035 as a kidney-protective treatment for patients undergoing open-heart surgery. This patient cohort serves as the basis for the study’s next major milestone – the second of two independent, company-blinded safety reviews. The outcome of this analysis is expected in the second quarter of 2025.

"Following the positive outcome of the first safety review earlier this year, we now look forward to the results of the second safety analysis. Patient recruitment has progressed faster than anticipated, which is gratifying and, of course, highly encouraging for the continued execution of the POINTER study," says Guard Therapeutics' CEO, Tobias Agervald.
 
As part of best practices, an independent Data Safety Monitoring Committee (DSMC) oversees safety data from the POINTER study. Safety reviews are conducted when one-third and two-thirds of the planned number of patients have been enrolled, respectively. Patient recruitment is expected to be completed in the third quarter of 2025, and the overall study results are anticipated approximately six months after completion of recruitment.

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