Highlights

  • Patrys completed dosing and follow-up activities for the first cohort of its RLS-2202 Phase 1a study.
  • The first cohort involved four healthy volunteers in a clinical safety and pharmacokinetic assessment.
  • A Safety Review Committee is expected to review the available cohort data in October 2026.
  • Progression to the second cohort remains subject to the committee’s review and required approvals.
  • The company has not reported safety results or clinical outcomes from the completed cohort.

Patrys Limited (ASX:PAB) is a clinical-stage biotechnology company focused on developing therapies for medical applications. The company’s latest announcement relates to its RLS-2202 Phase 1a clinical study, with the completion of dosing and follow-up activities for the first participant cohort. The update provides information on the trial process, planned safety review and upcoming development steps.

First Cohort Trial Completion

Patrys announced that all participants in Cohort 1 of its Phase 1a study of RLS-2202 had completed dosing and the required follow-up period. The first cohort consisted of four healthy volunteers as part of a broader two-cohort, two-period crossover clinical study.

The study is designed to evaluate safety, tolerability and pharmacokinetic characteristics of RLS-2202. The company stated that the trial includes both intravenous and oral dosing periods, with a total planned enrolment of 16 healthy volunteers across the two cohorts.

Safety Review Process

Following completion of the first cohort activities, the available safety, tolerability and pharmacokinetic information will be compiled and reviewed by a Safety Review Committee. Patrys expects the committee review to occur in October 2026.

The company has not disclosed the results of the first cohort. Completion of dosing and follow-up indicates that the planned trial activity for the first group has been completed, but it does not by itself provide confirmation of safety outcomes or treatment effects.

RLS-2202 Development Programme

RLS-2202 is a quetiapine formulation being developed by Patrys for delirium. The company acquired Reliis Pty Ltd in January 2026, which provided access to the RLS-2202 programme.

Patrys has stated that engineering batch Manufacturing was completed in March 2026 and that the clinical study design was finalised with relevant clinical partners. Ethics committee approval was received in August 2026 before the first participants were dosed in September 2026.

Future Clinical Milestones

The next major milestone for the programme is the Safety Review Committee assessment of Cohort 1 data. The company stated that a decision on progression to Cohort 2 has not yet been made.

If approved, Cohort 2 would involve 12 participants. Patrys expects the second cohort dosing activity to begin in the fourth quarter of 2026, subject to the required approvals and review outcomes.

Broader Company Activities

Alongside RLS-2202, Patrys continues to develop its Deoxymab antibody platform, including PAT-DX1 and PAT-DX3 programmes. The company’s latest announcement, however, focuses on the progress of the RLS-2202 clinical study.

The announcement does not provide new financial forecasts, clinical efficacy findings or commercial outcomes associated with the programme. Further disclosures will depend on future trial progress and company updates.

Key Insights

Patrys’ latest update marks the completion of the initial cohort activities in the RLS-2202 Phase 1a study. The announcement provides details on the clinical development timeline and upcoming review process, while additional information on safety findings and future trial progression remains subject to further disclosures.