About time for an update on this one… I’ve been following this (and holding for gods sake) for more than 5 years. It’s finally approaching the proper binary event that is phase 3 trial results. Looks as though the interim results will be released in August. If they are positive I expect a massive spike in share price which will no doubt be followed by a cap raise to see them through the rest of the trial etc. given my confidence in the drug itself I might accumulate a little more between now and then.
The market cap sitting at 100mil for a business I believe is on the cusp of a disease modifying drug for OA is in @Strawman’s terms ‘an asymmetric bet’. That said, it’s a binary outcome and that’s enough to reasonably keep plenty of people on the sidelines.
‹ Paradigm Achieves 50% Patien...
PARAIGM
BIOPHARMA
ASX RELEASE
31 March 2026
V
Paradigm Confirms 50% of Patients Dosed in Phase 3 OA Trial
Enabling Progress Toward Interim Analysis
Key Highlights
- 50% of patients now dosed in the global PARA_OA_012 Phase 3 study, which is on track consistent with the company's previously announced time schedule.
- Interim dataset is on schedule to undergo independent statistical analysis, with results expected in August 2026.
- Phase 3 study design closely aligns with the patient population and protocol of the successful PARA_OA_008 trial, while strengthening data quality and managing placebo response.
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 announce that 50% enrolment in the global Phase 3 PARA_OA_012 clinical trial has now been achieved, with dosing of the final participants required for inclusion in the interim analysis dataset having commenced.
Participants are followed from first dosing through the Day 112 assessment period in accordance with the study protocol.
Following completion of the Day 112 assessments, the interim dataset will undergo data cleaning and independent data monitoring committee (DMC) statistical analysis, which is expected to take approximately four to six weeks. Based on the current study timeline, Paradigm expects the interim analysis results to be delivered in August 2026.
The PARA_OA_012 study is designed to enrol 466 participants globally, with patients randomised to receive injectable pentosan polysulfate sodium (iPPS) or placebo. The primary endpoint of the study is the change in weekly average of daily pain at Day 112, with secondary endpoints including improvements in physical function, imaging-based structural outcomes, and safety assessments.
Patient recruitment continues across Paradigm's global network of clinical trial sites spanning Australia, the United States, Europe and Asia, as progression toward 100% enrolment is expected in the coming months.
The PARA_OA_012 Phase 3 trial has been designed to closely align with Paradigm's earlier PARA_OA_008 study, which demonstrated clinically meaningful improvements in pain and function. The two studies utilise a comparable patient population, the same dosing regimen of injectable pentosan polysulfate sodium (iPPS), and similar study duration and endpoints. Maintaining this consistency in trial design is intended to reduce development risk and support comparability across the clinical program.
Importantly, the PARA_OA_012 protocol also incorporates key learnings generated across Paradigm's earlier clinical studies, including the PARA_OA_002 dose-ranging study. These
