Biopharmaceutical company Dimerix (ASX:DXB) reports an independent Data Safety Monitoring Board (DSMB) have concluded a review of the ACTION3 phase three clincial trial.
The company reports the DSMB noted no safety concerns and recommended that the clinical trial continue as planned. Dimerix also notes the DSMB review was scheduled, and was pre-specified in the analysis plan.
The ACTION3 phase three trial is actively recruiting across clinical sites around the world, with 96 patients currently recruited to the company’s DMX-200 phase 3 trial in patients with focal segmental glomerulosclerosis (FSGS) kidney disease as of 7 February 2023.
“The DSMB’s positive recommendation is a key milestone”
Dimerix reports once patients have completed the background medication stabilisation period, and subsequent rescreening, they will then be randomized to receive either drug or placebo.
This phase three trial in FSGS patients has 2 interim analysis poitns built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating enough evidence to support accelerated marketing approval. The company notes part one interim analysis of the trial data will conclude once 72 patients have completed 35 weeks of treatment.
Commenting on the DSMB review, Dimerix Chief Medical Officer Dr. Ash Soman said: “The DSMB’s positive recommendation is a key milestone, which enables us to continue patient enrolment as planned and complete the trial as soon as possible.
The outcome from this DSMB analysis is entirely consistent with existing and growing strong safety profile of DMX-200. We have seen strong recruitment momentum across the study, and we look forward to reporting on the results of the interim analysis once the first 72 patients reach 35 weeks treatment.”
Dimerix reports the phase three trial is titled ‘Angiotensin II Type 1 Receptor (AT1R) and Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis’ or ACTION3.
This trial is a pivotal, multi-centre, randomised, double-blind, and placebo-controlled trial testing the efficacy and safety of DMX-200 in patients with FSGS who are recieving a stable dose of angiotensin II receptor blocker (ARB).
Once this dose is stable, patients aged between 18 and 80 will be randomised to receive either DMX-200 (120mg capsule twice daily) or placebo.
Dimerix is a clincal-stage biopharmaceutical company developing new therapies in areas with unmet medical needs for global markets. The company is currently developing its proprietary product DMX-200 for FSGS, respiratory complications associated with COVID-19, and diabetic kidney disease.
Currently, the company is also developing DMX-700 for chronic obstructive pulmonary disease (COPD). Both of these drugs were identified using the company’s proprietary assay, Receptor Heteromer Investigation Technology (Receptor-HIT), which is a scalable and globally applicable technology platform enabling the understanding of receptor interactions to screen, and identify new drug opportunities.