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- HREC approval received for trial of RLS-2202
- Phase 1A bridging study will evaluate the safety, tolerability and pharmacokinetics of RLS-2202
- Company will now progress clinical site activation, participant screening and recruitment
- First participant dosing remains on track to commence this quarter
Patrys (ASX: PAB) has received HREC approval to commence its Phase 1A clinical trial of RLS-2202 – which is being developed for the treatment of delirium in acute care settings.
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The Phase 1A study is designed to assess the safety, tolerability and pharmacokinetics of RLS-2202 in healthy volunteers. The study will generate important dosing information to inform subsequent stages of clinical development.
Receipt of Human Research Ethics Committee (HREC) approval follows completion of the required regulatory and preparatory activities and represents an important milestone in the clinical development of RLS-2202.
With ethics approval now in place, the company will progress clinical site activation and the remaining study start-up activities ahead of first participant dosing, which remains on track for this quarter.
Patrys continues to work closely with its manufacturing, bioanalytical, clinical site and CRO partners to ensure the study is conducted to the highest standards of quality, safety and scientific rigour.
CEO, Dr Samantha South, said receiving the approval is a significant step forward and reflects the strong progress being made across the program.
“We are now focused on initiating the study, recruiting participants and generating data to support the next stages of clinical development for RLS-2202.
“With first participant dosing expected this quarter, we look forward to providing shareholders with further updates as the study progresses.
“Delirium remains a significant unmet medical need, and we look forward to advancing this important clinical program.”
The approval permits the company to proceed with its Phase 1A bridging study evaluating the safety, tolerability and pharmacokinetics of RLS-2202 following intravenous and oral administration in healthy adult volunteers.
The study will employ a sequential dose-escalation design, with progression between the two cohorts subject to review by an independent Safety Review Committee in accordance with the study protocol.
The primary objective is to assess the safety and tolerability of RLS-2202.
Secondary objectives include evaluation of:
• Pharmacokinetic profile; and
• Dose levels to support subsequent clinical development.
Data generated from this study will support dose selection and the design of subsequent clinical trials.
With ethics approval now in place, Patrys will proceed with the remaining study start-up activities.
The company expects first participant dosing to occur this quarter.
Delirium is a sudden, severe change in brain function that causes confusion, trouble focusing, and rapid mental shifts. In Australia, it affects up to 18% of hospital patients aged 65 and older.
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