TrivarX Limited (ASX:TRI) has formally engaged Emeritus Research to conduct its planned Phase 1 healthy volunteer study of Stabl-Im at Emeritus' Melbourne clinical research facility, with first participant enrolment targeted for Q1 CY2027 and initial study results anticipated in Q2 CY2027, subject to ethics, regulatory and operational requirements.

Key Points

  • Emeritus Research formally engaged to conduct the Phase 1 healthy volunteer study of Stabl-Im at its Melbourne clinical research facility
  • Emeritus Research and its affiliates have over 25 years of experience conducting clinical trials across a broad range of therapeutic areas
  • The appointment follows the recent engagement of Syntro Health for investigational product formulation activities, with key delivery partners now in place
  • First participant enrolment targeted for Q1 CY2027, with initial study results anticipated in Q2 CY2027, subject to ethics, regulatory and operational requirements

Emeritus Research Engagement and Facility Details

Emeritus Research was selected for its established clinical trial infrastructure, experienced research personnel and participant recruitment capabilities, according to the filing. The Australian clinical research site network operates a Melbourne facility that combines dedicated clinical research infrastructure with research-dedicated clinicians and disciplined processes and procedures. Emeritus and its affiliates have conducted clinical trials across a broad range of therapeutic areas. The company said the engagement secures the clinical site and specialist capabilities and qualifications required to deliver the study.

Phase 1 Study Scope and Stabl-Im Platform

The planned Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of controlled systemic deuterium enrichment in healthy volunteers, including how enrichment develops and washes out over time. Stabl-Im is TrivarX's stable isotope-based imaging development platform, which uses controlled enrichment with deuterium — a non-radioactive stable isotope of hydrogen — to investigate whether metabolic differences between healthy and cancer tissue can be detected using magnetic resonance imaging. The platform has an initial focus on brain tumours and brain metastases. The filing states the study is designed to establish a clinical data foundation for subsequent development.

Preparations and Next Steps Towards Study Commencement

Clinical site preparations, investigational product preparation and specialist analytical methodology development are progressing towards the targeted first participant enrolment in Q1 CY2027, the filing states. TrivarX said it will work closely with Emeritus to finalise site-specific study preparations, ethics and regulatory submissions, recruitment planning and operational readiness ahead of study commencement. These activities will progress in parallel with investigational product preparation and analytical methodology development. The company's CEO, Dr Danielle Meyrick, is quoted in the filing noting that the Emeritus engagement, together with the Syntro Health appointment, establishes key delivery partners ahead of study commencement.