Highlights

  • Patrys (ASX:PAB) received Human Research Ethics Committee approval for its Phase 1A clinical trial of RLS-2202.
  • The study will assess safety, tolerability and pharmacokinetics of RLS-2202 in healthy volunteers.
  • Clinical site activation, participant screening and recruitment activities will now progress.
  • First participant dosing remains on track to commence during the quarter.
  • Patrys traded at AUD 0.031, up 3.33% during the morning session on 28 August 2026.

Patrys Limited (ASX:PAB) has received Human Research Ethics Committee (HREC) approval to commence its Phase 1A clinical trial of RLS-2202 in healthy volunteers, marking a further step in the development of the company’s clinical program.

During the morning session on 28 August 2026, Patrys (ASX:PAB) was trading at AUD 0.031, up 3.33%. The stock remains up 3.33% over the past year.

Trial Progress

The Phase 1A study is designed to evaluate the safety, tolerability and pharmacokinetics of RLS-2202 in healthy volunteers. Patrys said the study will generate dosing information to support subsequent stages of clinical development.

The HREC approval follows completion of required regulatory and preparatory activities, allowing Patrys to move into clinical site activation and remaining study start-up activities before first participant dosing.

The company continues to work with manufacturing, bioanalytical, clinical site and contract research organisation partners to support the conduct of the study.

RLS-2202 Study

The Phase 1A trial is a bridging study evaluating the safety, tolerability and pharmacokinetic profile of RLS-2202 in healthy adult volunteers. The study will assess intravenous and oral administration of the treatment candidate.

The trial will use a sequential dose-escalation design, with movement between cohorts subject to review by an independent Safety Review Committee in accordance with the study protocol.

The primary objective of the study is to assess safety and tolerability, while secondary objectives include evaluation of pharmacokinetic characteristics and dose levels to support future clinical development.

Patrys said the data generated from the trial will support dose selection and the design of future clinical studies.

Next Steps

Following HREC approval, Patrys will proceed with additional trial preparation activities, including notification to the Therapeutic Goods Administration (TGA) under the Clinical Trial Notification (CTN) Scheme.

The company will also complete trial registration on the Australian New Zealand Clinical Trials Registry (ANZCTR), clinical site initiation, participant screening and participant enrolment.

Patrys expects first participant dosing to occur during the quarter once these activities are completed and will provide further updates as the trial progresses.

Management Commentary

Patrys CEO Dr Samantha South said the company was pleased to receive ethics approval for the Phase 1A clinical trial and viewed the milestone as progress across the RLS-2202 program.

Dr South said the company’s focus would now move towards initiating the study, recruiting participants and generating data to support the next stages of clinical development for RLS-2202.

She also noted that first participant dosing remained expected during the quarter as the company continues advancing the clinical program.

Company Focus

Patrys is a clinical-stage company developing an injectable therapy for delirium alongside its deoxymab platform targeting immune-mediated inflammatory diseases.

The company’s current focus is advancing RLS-2202 through clinical development, with the Phase 1A study intended to provide early safety and pharmacokinetic data to guide future development activities.

Investor Takeaway

Patrys’ latest update marks a regulatory milestone for the RLS-2202 program, with HREC approval allowing the company to progress towards clinical trial commencement. Investors may continue watching participant recruitment, first dosing progress and data generated from the Phase 1A study as the program advances.