Guard Therapeutics have announced that 134 of the planned 268 patients have been dosed in the global randomized, double-blinded and placebo-controlled Phase 2 clinical trial (AKITA).
The AKITA study has been designed to evaluate the kidney-protective effects of the investigational drug RMC-035 in conjunction with open heart surgery. An interim analysis will be conducted by an independent Data Monitoring Committee (DMC) who will provide a recommendation in April regarding the continuation of the study.
“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 Guard Therapeutics.
An interim analysis
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 Guard Therapeutics will receive the DMC recommendation (according to the alternatives below) without disclosure of any results from the analysis.
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 April 2023. Patient recruitment will continue until further notice.
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 study, states the company.