Investigational product supply secured for TrivarX’s Stabl-Im imaging trial
TrivarX (ASX: TRI) has secured the investigational product supply required to initiate the planned Phase 1 clinical feasibility trial of its Stabl-Im imaging platform. The development supports the company’s targeted commencement of clinical activity in CY2026.
Stabl-Im is an MRI-based functional imaging platform designed to provide information on tumour biology using stable isotopes, without the use of radioactive tracers. Securing the investigational product supply marks an important milestone that moves the company toward an important evaluation of the technology in humans.
When big ASX news breaks, our subscribers know first
Why the supply milestone matters
Securing investigational product supply is a prerequisite gate to running any clinical trial. Without the material required to conduct the study, a trial cannot commence. The milestone therefore represents a necessary step in TrivarX’s clinical development program for Stabl-Im.
The announcement reflects steady, sequential progress across the clinical, regulatory and operational workstreams required to bring the platform into the clinic. The following outlines what has been secured and what remains outstanding:
- Investigational product supply — secured
- Clinical protocol finalisation — in progress (via Beyond Drug Development)
- Clinical site identification and engagement — in progress
- Regulatory, ethics and site approvals — pending
The company recently engaged specialist contract research organisation Beyond Drug Development, which is supporting finalisation of the clinical protocol and associated documentation, together with clinical site identification and engagement.
The Beyond Drug Development engagement covers completion of the Phase 1 clinical protocol, preparation of regulatory documentation, and clinical site selection, with the CRO’s team averaging over 20 years of clinical development experience across the programme.
Importantly, commencement of the trial remains subject to completion of these activities and receipt of the necessary ethics and site approvals. The study has not yet started.
CEO Commentary
“Securing investigational product supply is an important milestone as we continue to execute our clinical development strategy for Stabl-Im and underpins progress towards commencement of the planned Phase 1 clinical feasibility trial in CY2026,” said Dr Danielle Meyrick, Chief Executive Officer of TrivarX.
Understanding Stabl-Im: MRI imaging without radioactive tracers
Stabl-Im takes a different approach, using stable isotope labelling combined with magnetic resonance imaging (MRI).
Stable isotopes are non-radioactive variants of common elements. By pairing them with MRI, the platform is designed to generate biologically meaningful information without introducing radioactive material into the imaging workflow.
A key feature of the platform is that it leverages existing MRI infrastructure already present in hospitals. The platform leverages existing MRI infrastructure. The platform is being developed to provide information on tumour activity, cell proliferation and treatment response.
For investors, the significance lies in the platform’s potential to complement existing standard-of-care imaging. By working within the existing MRI base found across healthcare facilities, Stabl-Im is positioned to address the neuro-oncology imaging market.
| Feature | What it does | Why it matters |
|---|---|---|
| Stable isotope labelling | Imaging without radioactive tracers | Avoids complex clinical workflows |
| Uses existing MRI | Leverages existing MRI infrastructure | Utilises current MRI infrastructure |
| Measures tumour biology | Activity, proliferation, response | Complements standard-of-care |
What the Phase 1 study is designed to deliver
The planned study is designed to evaluate the safety of the Stabl-Im approach and generate preliminary data regarding its clinical feasibility and imaging performance. It represents an important evaluation of the technology in humans.
According to the company, the study is intended to generate expanded human safety data, together with preliminary evidence regarding the platform’s clinical feasibility and imaging performance.
For investors, successful feasibility and imaging data would support validation of the platform in a clinical setting and could underpin advancement of the company’s neuro-oncology program. The outcome remains dependent on the study proceeding and delivering the intended data.
The next major ASX story will hit our subscribers first
Next steps and CY2026 timeline
With investigational product supply secured, the company remains focused on completing the remaining activities required before the trial can commence:
- Finalising the trial design and protocol
- Selecting and engaging clinical sites
- Completing regulatory, ethics and operational activities
- Receiving the necessary ethics and site approvals
TrivarX is targeting commencement of the Phase 1 trial in CY2026, explicitly subject to completion of these activities and receipt of the required approvals.
TrivarX is a healthcare technology company focused on developing diagnostic and imaging solutions across mental health and neuro-oncology. Its proprietary technologies include AI-driven algorithms for the detection of mental health conditions using physiological signals, alongside the Stabl-Im platform.
Don’t Miss the Next Healthcare Breakthrough on ASX
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis already done. Join 20,000+ subscribers staying ahead of market-moving developments. Click the “Free Alerts” button at StockWire X to start receiving real-time alerts the moment ASX healthcare announcements drop.