Pathkey.AI Subsidiary TrialKey Signs A$25,000 Services Agreement with Paradigm for Phase 3 Osteoarthritis Trial Evaluation

Aditi Sarkar

10 November 2026 12:56 PM AEDT

Pathkey.AI Subsidiary TrialKey Signs A$25,000 Services Agreement with Paradigm for Phase 3 Osteoarthritis Trial Evaluation

Image Source: Krish Capital Pty Ltd

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Pathkey.AI Ltd (ASX:PKY) has disclosed that its subsidiary TrialKey Pty Ltd has signed a services agreement valued at A$25,000 plus GST with Paradigm Biopharmaceuticals Ltd (Administrators Appointed) to provide an independent evaluation of Paradigm's PARA_OA_012 Phase 3 osteoarthritis study.

Key Points

TrialKey has signed a services agreement with Paradigm with a total value of A$25,000 plus GST.
TrialKey will independently assess Paradigm's PARA_OA_012 Phase 3 trial, examining protocol, statistical analysis plan and de-identified study data.
Paradigm is in voluntary administration, with Christopher Pattinson and Hayden White of FTI Consulting appointed as joint and several voluntary administrators on 29 September 2026.
TrialKey's internal testing demonstrated improved primary-endpoint AUC results, increasing from 0.745 to 0.807, based on retrospective internal testing.
Further priorities disclosed include delivery of the Paradigm engagement, additional biotech engagements and clinical research organisation pilot licensing.

Paradigm Phase 3 Trial Evaluation Scope

TrialKey will examine the protocol, statistical analysis plan and de-identified study data from Paradigm's PARA_OA_012 trial, which evaluated injectable pentosan polysulfate sodium for knee osteoarthritis. According to the filing, the independent Data Safety Monitoring Board confirmed on 23 September 2026 that the interim efficacy result did not reach the pre-specified threshold required for continuation. Subsequent updates identified regional differences between United States and rest of world results, along with missing assessments and dosing interruptions as matters requiring further analysis. TrialKey's deliverables will include an integrated technical report and recommendations on study design, endpoints, sample size, missing-data management and trial conduct.

TrialKey Platform Capabilities

The filing states that TrialKey currently operates 14 live services, using machine-learning models trained on historical clinical trial data to generate predictive insights, risk assessments and recommendations. Core capabilities disclosed include ML-guided AI optimisation, confidential protocol assessment, statistical analysis plan review, clinical trial cost modelling, and competitor and trial similarity analysis. The platform allows customers to upload a confidential draft protocol or begin with an indication and treatment-type idea, without requiring a public registry entry or trial identifier. The filing notes that additional statistical functions are undergoing testing or client validation.

Engagement Terms and Disclosed Limitations

According to the filing, Paradigm's de-identified data will be used solely to perform the engagement and will not be used to train, develop or validate TrialKey's models. The filing states that the internal model results reported do not use Paradigm data, and that the reported performance results are based on internal retrospective testing. The filing also discloses that neither Paradigm nor its administrators has reviewed or endorses TrialKey's platform, model results or other statements in the filing. The filing explicitly states the current work does not establish treatment efficacy or guarantee future trial success, regulatory acceptance or funding.

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