Guard Therapeutics has announced top-line results from its AKITA study, evaluating RMC-035 for the prevention of kidney injury in open-heart surgery.
Patient recruitment was prematurely stopped, and as expected the primary (short-term) endpoint, incidence of acute kidney injury (AKI) within 72 hours after surgery, was not reached, describe sthe company.
“Importantly though, pre-defined secondary endpoints demonstrated the intended long-term benefit of RMC-035 with improved kidney function compared to placebo,” the company states. “These results clearly support advancement in the clinical development program and highlight the potential of RMC-035 as a novel short-term treatment for kidney protection.”
The study has clearly demonstrated the efficacy signals needed to advance the project towards a future pivotal study.”
“We are very excited by the results of this Phase 2 trial with RMC-035. Whereas the chosen primary (acute) endpoint AKI failed, it is important to note that AKI merely serves as a short-term prognostic indicator of clinically relevant outcomes, including long-term kidney function and Major Adverse Kidney Events (MAKE). The actual efficacy of RMC-035 assessed by these hard clinical outcomes is far above expectations and makes the chosen primary endpoint, AKI, irrelevant in this context,” says Tobias Agervald, CEO at Guard Therapeutics. “The study has clearly demonstrated the efficacy signals needed to advance the project towards a future pivotal study. With these results we are back on track, strengthened in our confidence to establish a new and unique treatment for the prevention of kidney injuries in heart surgery and proceed with the clinical development of RMC-035 as planned. We are eagerly awaiting further discussions with regulatory authorities, and we look forward to providing more information about the clinical pathway shortly.”