The AKITA study is a global, randomized, double-blind and placebo-controlled phase 2 study and aims to evaluate the kidney-protective effect of RMC-035 in conjunction with open heart surgery.
The company has decided to follow the DMC recommendation, which means that further patient recruitment is discontinued and that the study is terminated prematurely because the probability of achieving the study's main objectives is considered low. The recommendation is based on an analysis of both efficacy and safety data.
"We will now analyze the unblinded results and make our own more comprehensive analyses of the study results and then decide upon next steps", says
The company has so far only received the DMC recommendation regarding the continuation of the study, but no unblinded data.
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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