Ann: Successful Completion of 2nd DSMB Review of FSGS Trial, page-2

AND HERE 'TIS

For Immediate Release
SUCCESSFUL COMPLETION OF SECOND PLANNED DSMB
REVIEW OF ACTION3 PHASE 3 FSGS KIDNEY TRIAL
• Second scheduled independent Data Safety Monitoring Board (DSMB) review, evaluating the
available study data for participant safety, study conduct and progress, has been successfully
completed
• The DSMB recommends the ACTION3 clinical trial continue unchanged
• DSMB has again noted no safety concerns to date, which is entirely consistent with the existing
and growing strong safety profile of DMX-200
• Part 1: Last patient data collection for Phase 3 study scheduled for 26 February 2024
• Part 1: First interim data outcome expected to be reported on, or around, 15 March 2024
• The trial has two interim data analysis points, the second of which may enable accelerated
marketing approval2
• FSGS is a rare disease with no existing long term treatment options specifically for sufferers3
• Total FSGS market size across the 7 major markets estimated to be >US$3 billion by 2032 driven
by approximately 220,000 FSGS sufferers across the 7 major markets4 and premium orphan drug
pricing5
MELBOURNE, Australia, 08 August 2023: Dimerix Limited (ASX: DXB) a biopharmaceutical company
with late-stage clinical assets in inflammatory diseases, today confirmed that the independent Data
Safety Monitoring Board (DSMB) has successfully concluded a second review of the ACTION3 phase 3
clinical trial. Following the routine, scheduled review, the DSMB has noted no safety concerns and
recommended that the clinical trial continue as planned.
Undertaking a review by an independent DSMB is consistent with good clinical practice,
6 and was prespecified in the analysis plan. The primary responsibilities of the DSMB 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 a DSMB as well as provision for interim
safety reviews, the second of which has now been successfully completed.
FSGS Phase 3 Study
The Phase 3 study, which is titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2
(CCR2) Targets for Inflammatory Nephrosis” – or ACTION3 for short, is a pivotal (Phase 3), multicentre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 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 randomized to receive either DMX-200 (120 mg capsule twice
daily) or placebo.
The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to
capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating
sufficient evidence to support accelerated marketing approval. A successful outcome in the first
interim analysis outcome, expected on or around 15 March 2024 1 would see the Company announce
a clinically significant and statistical meaningful improvement in proteinuria in patients on DMX-200
versus placebo and that the trial is continuing to Part 2.
Further information about the study can be found on ClinicalTrials.gov (Study Identifier:
NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier
ACTRN12622000066785).
For further information, please visit our website at www.dimerix.com or contact:
Dr Nina Webster
Dimerix Limited
Chief Executive Officer & Managing Director Tel: +61 1300 813 321
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GLALTH Mal