Posted: 20 November 2024
Dimerix Limited (ASX: DXB) a biopharmaceutical company with late-stage clinical assets in inflammatory diseases, today confirmed that the Independent Data Monitoring Committee (IDMC) successfully concluded a fifth review of the ACTION3 phase 3 clinical trial safety data. Following this routine, scheduled review, the IDMC has noted no safety concerns and recommended that the clinical trial continue as planned.
Undertaking a review by an IDMC is consistent with good clinical practice, 1 and was pre-specified in the study protocol. The primary responsibilities of the IDMC are to review and evaluate the available study data for participant safety, study conduct and progress, and to make recommendations concerning the continuation, modification, or termination of the trial. The study protocol for the ACTION3 clinical trial includes oversight by an IDMC as well as provision for interim safety reviews, the fifth of which has now been successfully completed.
“This encouraging recommendation of the IDMC confirms the strong emerging safety profile of DMX-200 and suggests that DMX-200 does not add a burden of side effects to patients, compared
to commonly used treatments such as high dose steroids and immunosuppressants. DMX-200 represents a real hope for the many patients suffering from FSGS kidney disease who currently have limited treatment options.” Dr David Fuller, Chief Medical Officer, Dimerix
