Guard Therapeutics is focused on developing innovative therapies for kidney disease, particularly through its lead drug candidate, RMC-035. This first-in-class biological drug is designed to mimic the endogenous protein alpha-1-microglobulin and aims to prevent acute kidney injury (AKI) in patients undergoing high-risk procedures such as open-heart surgery. RMC-035 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) and has been granted Fast Track Designation to expedite its development. The drug is administered intravenously and is intended to protect renal function by mitigating damage caused by ischemia-reperfusion injury and hemolysis during surgery.

Currently, RMC-035 is being evaluated in multiple clinical studies, including the ongoing Phase 2b POINTER study, which aims to establish optimal dosing and identify the target patient population for future pivotal trials. The POINTER study will enroll approximately 160 patients across various European clinics, assessing the drug's efficacy in improving kidney function post-surgery. Previous studies, such as the Phase 2a AKITA study, have shown promising results, indicating a significant improvement in kidney function and a reduction in major adverse kidney events. Guard Therapeutics is committed to advancing RMC-035 through rigorous clinical evaluation to address the critical need for effective treatments in kidney injury prevention.

Sweden

Guard Therapeutics is developing innovative therapies focusing on kidney diseases. The company's lead clinical asset, RMC-035, is in phase 2b development for the prevention and treatment of kidney injuries in patients undergoing open heart surgery. The company also has preclinical candidate drugs intended for the treatment of chronic kidney disease, targeting specific disease segments such as FSGS, IgAN, Alport Syndrome and DKD. 
Listed on Nasdaq First North Growth Market.

Guard Therapeutics

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