"It is gratifying that the patient recruitment to the AKITA study is proceeding according to plan. With half of the patients included, we now look forward to receiving the DMC recommendation regarding the remaining part of the study, while the recruitment of additional patients continues unabated", said Tobias Agervald, CEO of
Based on the current patient data, an interim analysis will be conducted that will form the basis for the external and independent DMC recommendation on the continuation and potential modification of the study. The interim analysis consists of two parts: an analysis of safety data and a separate evaluation of the study's primary and several secondary endpoints. To preserve the validity and data integrity of the study, unblinded study results will be reviewed by the DMC only, whereas
Based on the efficacy data analysis, the DMC recommendation can result in three different outcomes: 1) that the study continues according to plan with unchanged study protocol, 2) that the study is expanded to include a total of 348 patients with the purpose to increase the probability that the primary endpoint will be statistically significant, or 3) that the study is terminated prematurely. There is also a possibility of modifying the inclusion criteria in the study.
The interim analysis is planned to be conducted during the first quarter of 2023, while the outcome of the DMC recommendation is expected to be available in
The top-line results from the complete study are expected to be available at the turn of the year 2023/2024 and will form the basis for a subsequent pivotal study.
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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