80% Safety Review Complete, September IA on Track
Released
Released
Announcement PDF
ASX RELEASE 13 August 2026
Phase 3 OA Trial Continues Unchanged Following Formal DSMB 80%
Safety Review, September Interim Analysis on Track
Paradigm Biopharmaceuticals Ltd (ASX:PAR) (“Paradigm” or “the Company”), a late-
stage drug development company focused on delivering new therapies to address
unmet medical needs, is pleased to provide an update on its pivotal Phase 3
PARA_OA_012 clinical trial.
The independent Data Safety Monitoring Board (DSMB) has completed its planned
safety review of approximately 80% of participants who have completed dosing (Day
39) in the PARA_OA_012 study. Following its review of the available safety data, the
DSMB has recommended that the trial continue without modification.
This represents the third formal DSMB safety review successfully completed during
PARA_OA_012, following the previously scheduled 20% and 50% reviews, each of
which also supported continuation of the study.
Completion of the 80% review represents another important de-risking milestone for
the Phase 3 program as PARA_OA_012 progresses towards its next major clinical
milestone, the planned interim analysis in September 2026.
The DSMB is an independent committee responsible for monitoring participant safety
and the ongoing integrity and scientific validity of the clinical trial. The recommendation
to continue the study unchanged following successive planned safety reviews supports
continued execution of PARA_OA_012 as designed.
Next Major Milestone – Interim Analysis
With the 80% safety review now completed, Paradigm reaffirms its guidance that the
PARA_OA_012 interim analysis remains on track for September 2026.
The pre-specified interim analysis represents the next major clinical milestone for the
Company and will assess treatment effect on the study’s primary pain endpoint at Day
112.
The interim analysis will be conducted in accordance with the pre-specified statistical
analysis plan and independent DSMB process. Timing remains subject to completion
of the required data cleaning, biometrics and independent review processes.
Paradigm Chief Medical Officer, Dr Donna Skerrett, commented: “The recommendation
to continue PARA_OA_012 unchanged following the 80% safety review represents
another important milestone for the Phase 3 program and builds on the outcomes of
the earlier 20% and 50% DSMB reviews.
With three formal DSMB safety reviews now completed and the study continuing as
designed, our focus turns to the September interim analysis and the assessment of
treatment effect at Day 112. We remain pleased with the execution of the study as we
approach this important milestone for the program.”
About the Phase 3 PARA_OA_012 Clinical Trial
PARA_OA_012 is a randomised, double-blind, placebo-controlled, multicentre Phase 3
clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) in participants
with knee osteoarthritis (kOA).
The study is designed to enrol approximately 466 participants, randomised 1:1 to
receive iPPS or placebo over a 6-week treatment period. The primary endpoint is the
change in pain intensity at Day 112, measured as the weekly average of daily pain
scores.
Secondary endpoints include measures of function, patient-reported outcomes, and
structural assessments, providing a comprehensive dataset to support regulatory
evaluation.
An interim analysis is planned once approximately 50% of participants reach Day 112,
with outcomes guiding continuation in line with the study’s predefined statistical
framework.
About Paradigm Biopharmaceuticals
Paradigm Biopharmaceuticals Ltd. (ASX:PAR) is a late-stage drug development
company driven by a purpose to improve patients’ health and quality of life by
discovering, developing, and delivering pharmaceutical therapies. Paradigm’s current
focus is developing injectable (subcutaneous) pentosan polysulfate sodium (iPPS) for
the treatment of diseases where inflammation plays a major pathogenic role, indicating
a need for the anti-inflammatory and tissue regenerative properties of PPS, such as in
osteoarthritis (phase 3) and mucopolysaccharidosis (phase 2).
Authorised for release by the Paradigm Board of Directors.
To learn more please visit: www.paradigmbiopharma.com
FOR FURTHER INFORMATION PLEASE CONTACT:
Simon White
Director of Investor Relations
Tel: +61 404 216 467
Paradigm Biopharmaceuticals Ltd.
ABN: 94 169 346 963
Level 15, 500 Collins St, Melbourne, VIC, 3000, AUSTRALIA
Email: investorrelations@paradigmbiopharma.com
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