Dimerix (ASX:DXB) has confirmed that the Independent Data Monitoring Committee (IDMC) successfully concluded a sixth review of the ACTION3 phase 3 clinical trial safety data.
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.
The company said that following this scheduled review, the IDMC has noted no safety concerns and recommended that the clinical trial continue as planned.
The Phase 3 ACTION3 study is a pivotal, multicentre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomised to receive either DMX200 or placebo. The Phase 3 trial in FSGS patients is designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, with the aim of generating sufficient evidence to support marketing approval.
Dimerix chief medical officer Dr David Fuller said, “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.”
