Patrys (ASX:PAB) has taken a step toward clinical-stage development of its RLS-2202 program by appointing CMAX as the Phase 1A clinical trial site and Alithia Life Sciences as the contract research organisation to manage the study.
RLS-2202 is a proprietary injectable formulation of quetiapine intended to provide rapid, predictable and effective treatment of delirium in acute care settings.
The company said the two appointments complete an operational milestone that follows earlier manufacturing and regulatory de-risking activities and establishes the framework for a bridging Phase 1A study assessing safety, tolerability, and pharmacokinetics in healthy volunteers.
CMAX, a specialised Phase 1 clinical unit in Adelaide, will serve as the physical site where participants are dosed and monitored, bringing specialist infrastructure, experienced investigators and participant recruitment capabilities.
Alithia will coordinate the broader operational, regulatory and clinical oversight functions, providing project management, regulatory coordination, data management, monitoring, pharmacovigilance, vendor oversight, biostatistics and trial administration to ensure adherence to Good Clinical Practice and regulatory requirements.
Patrys said it plans to submit the Human Research Ethics Committee application in the second quarter of 2026 and, subject to approval, remains on track to begin dosing in the third quarter.
CEO, Dr Samantha South, said, “The appointments of CMAX and Alithia are critical to the execution of the RLS-2202 Phase 1A clinical trial and we are pleased to partner with highly experienced organisations with strong track records in early-stage clinical development and Phase 1 execution. These appointments establish an important operational framework as we advance RLS-2202 toward first participant dosing and continue progressing the program towards clinical-stage development. RLS-2202 is designed to address the significant unmet need for delirium treatment in acute care settings, and, subject to approvals, we remain on track for first participant dosing in Q3 CY2026.”
Associate Professor Tina Soulis, Alithia’s Founder and Director, said, “This collaboration is exciting and we are proud to be involved in the journey of an Australian company doing great things."