Guard Therapeutics is a Swedish biotechnology company developing innovative drugs in areas with significant medical needs, with a particular focus on kidney disease. Acute and chronic kidney disease represent a growing global health challenge, associated with high mortality, morbidity, and considerable healthcare costs. The company is listed on Nasdaq First North Growth Market Stockholm.
Our leading drug candidate, RMC-035, is being developed as a short-term hospital treatment to protect the kidneys from injury that can occur during procedures such as open-heart surgery. Such injury can lead to permanent loss of kidney function loss and an increased risk of end-stage renal disease (ESRD) and the need for dialysis. The project is currently in phase 2b, with clinically validated proof of concept.
RMC-035 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA), allowing clinical trials to be conducted in the U.S. This approval is a critical quality mark, granted after a rigorous review of safety data and preclinical studies.
In addition to IND clearance, RMC-035 has been granted Fast Track Designation (FTD) by the FDA, aimed at accelerating the development of treatments that address significant unmet medical needs. FTD helps expedite the approval process to ensure that new therapies reach patients with serious diseases faster. In this case, the goal is to reduce the risk of irreversible loss of kidney function, dialysis, or death following open-heart surgery in patients at high risk for acute kidney injury.
Guard Therapeutics is also developing a patented preclinical drug platform of novel peptides (“GTX peptides”), which have demonstrated robust treatment effects in various models of chronic kidney disease.
The company is driven by a small but highly specialized team with world-class expertise in science, medicine, and drug development, headquartered in Stockholm.