"Following the FDA's clearance of our IND application, it is gratifying that inclusion of patients in the AKITA study also has started in the US. With additional high-quality investigational sites activated, we are accelerating patient recruitment and raising awareness of our kidney-protective treatment concept ahead of a potential future product launch in the US. We look forward to the outcome of the blinded interim evaluation in April that will be conducted by an independent Data Monitoring Committee based on the treatment of half of the planned number of patients in the study. Our goal is to be able to present topline results at the turn of the year", said
RMC-035, which represents a completely new class of drugs (first-in-class), can protect cells and their mitochondria against injury caused by oxygen deficiency and elevated levels of the oxygen-binding and toxic protein heme. RMC-035 is currently being evaluated in the AKITA study for the prevention of acute kidney injury in open heart surgery and in a Phase 1b study in kidney transplantation.
The dosing of the first patient in the US in the AKITA study took place at Indiana Ohio Heart,
About RMC-035
RMC-035 is a first-in-class investigational drug that consists of a recombinant and modified variant of the endogenous protein alpha-1-microglobulin. Its mechanism of action includes protection of cells and their mitochondria against injury caused by ischemia and elevated levels of the oxygen-binding and toxic protein heme. Robust treatment effects of RMC-035 have been observed in several different preclinical disease models. RMC-035 has a natural biodistribution to the kidneys and is primarily developed as an intravenous renal protective treatment in patients who are at high risk of developing acute kidney injury (AKI).
RMC-035 has received an IND approval from the
About AKITA
AKITA is a global, randomized, double-blind and placebo-controlled Phase 2 clinical trial evaluating the renal protective effect of the company’s investigational drug RMC-035 in patients at increased risk of developing acute kidney injury (AKI) in open heart surgery. The AKITA study is planned to include 268 patients at up to 30 trial centers in both
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