Guard Therapeutics has reached a significant milestone with the dosing of the first patient in its phase 2b clinical study, POINTER, focusing on the drug candidate RMC-035 for kidney protection in open-heart surgery. The study commenced at the Quebec Heart and Lung Institute under the supervision of Dr. Maxime Laflamme, with plans to expand patient recruitment to Germany, Spain, and the Czech Republic by fall.
The POINTER study is designed as a randomized, double-blind, and placebo-controlled trial, aiming to enroll approximately 160 patients across two dosage arms of RMC-035 (60 mg and 30 mg) and a control arm receiving a placebo. The primary goal is to establish the optimal dosing regimen and exact target population for RMC-035, setting the stage for a pivotal phase 3 study.
A key efficacy measure of the study is the change in eGFR from the study's start to the 90-day follow-up post-surgery. With patient recruitment expected to last about a year, the overall results of the study are anticipated to be available 6 months after recruitment concludes.
Tobias Agervald, CEO of Guard Therapeutics, expressed satisfaction with the study's initiation, highlighting its importance in the clinical development of RMC-035 for open-heart surgery patients.
