Guard Therapeutics is a Swedish biotechnology company that develops novel therapies for diseases with a great medical need for more effective treatments. Our key therapeutic area is nephrology with a focus on acute kidney injuries.
The company is listed on Nasdaq First North Growth Market Stockholm.
Our company is driven by a small team of world-leading scientific, medical and drug development expertise within nephrology.
RMC-035 is our most advanced investigational drug which is being developed as a kidney protective treatment in patients undergoing open heart surgery. It is currently in Phase 2 clinical development with a global Phase 2 study running both in Europe and North America.
RMC-035 has received IND (Investigational New Drug) clearance by the U.S. Food and Drug Administration (FDA) which means that clinical studies of RMC-035 can be conducted in the U.S. This is also an important seal of quality given the rigorous assessment conducted by the FDA within the framework of an IND application.
Guard Therapeutics has also been granted Fast Track designation by the FDA for reducing the risk of an irreversible loss of kidney function, initiation of kidney replacement therapy or death following open-chest cardiac surgery in patients who are at increased risk for acute kidney injury. FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs aimed at treating serious conditions which have a large unmet medical need, with the goal to provide patients earlier access to such drugs.
Consequently, treatment with RMC-035 has the potential to save lives and prevent other severe consequences of acute kidney injury such loss of kidney function and need for renal replacement therapy.
Guard Therapeutics has a proprietary platform of additional research molecules which are currently being evaluated for further preclinical development for kidney diseases.
In our clinical trials programme we currently have two ongoing studies. A phase 2 study in patients undergoing cardiac surgery and a phase 1b study in kidney transplantation.Read more