Patrys Locks in Trial Site and CRO to Target First Dosing by Q3 2026
Patrys locks in trial site and CRO as RLS-2202 Phase 1 moves closer to first dosing
Patrys Limited (ASX: PAB) has appointed CMAX as its Phase 1A clinical trial site and Alithia Life Sciences as its Contract Research Organisation (CRO), completing the operational framework required to commence the company’s RLS-2202 Phase 1A clinical development activities. The two appointments follow a competitive evaluation process and establish the key organisational roles needed to advance the bridging Phase 1A study in healthy volunteers. With the Human Research Ethics Committee (HREC) application targeted for Q2 CY2026, the company reports it remains on track for first participant dosing in Q3 CY2026, subject to HREC approval.
Dr Samantha South, Chief Executive Officer
“The appointments of CMAX and Alithia are critical to the execution of the RLS-2202 Phase 1A clinical trial… subject to approvals, we remain on track for first participant dosing in Q3 CY2026.”
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Understanding the two appointments and what they each do
The RLS-2202 Patrys Phase 1 trial requires two distinct organisations: one to serve as the physical clinical site where dosing and monitoring will occur, and another to manage the broader operational and regulatory infrastructure of the study.
CMAX — the Phase 1A clinical trial site
CMAX is a specialised Phase 1 clinical unit based in Adelaide, with extensive experience in early-stage and first-in-human studies across a broad range of therapeutic areas. Its role in the RLS-2202 program is specifically as the physical site where study participants will be dosed and monitored throughout the trial. The selection of CMAX gives Patrys access to:
- Specialist Phase 1 infrastructure
- Experienced clinical investigators
- Established participant recruitment capabilities
Alithia Life Sciences — the Contract Research Organisation (CRO)
Alithia Life Sciences has been appointed to coordinate and manage the broader operational, regulatory, and clinical oversight aspects of the Phase 1A trial. Its remit is intended to ensure the study is executed to high operational and quality standards, enabling reliable interpretation of safety, tolerability, and pharmacokinetics (PK) data.
As CRO, Alithia’s service scope includes:
- Project management
- Regulatory coordination
- Data management
- Monitoring protocol adherence
- Pharmacovigilance
- Vendor oversight
- Trial administration
- Biostatistics
- Reporting in accordance with Good Clinical Practice (GCP) requirements
Both organisations were selected through a competitive evaluation process, reflecting their strong track records in delivering high-quality Phase 1 data and efficient operational timelines.
A/Prof Tina Soulis, Founder and Director, Alithia Life Sciences
“This collaboration is exciting and we are proud to be involved in the journey of an Australian company doing great things.”
What is RLS-2202 and why does delirium represent a significant unmet need?
RLS-2202 is a proprietary injectable formulation of Quetiapine, designed for use in acute care settings to provide rapid, predictable, and effective treatment of delirium. Quetiapine is a well-established antipsychotic medicine that already has an extensive clinical and safety record in oral form; RLS-2202 repurposes it as an intravenous (IV) formulation specifically for acute hospital use.
Delirium is an acute state of confusion that commonly affects hospitalised patients, particularly the elderly and those in intensive care. It is associated with prolonged hospital stays and serious clinical complications, yet there is currently no approved IV treatment option available, representing a significant gap in acute care medicine.
The program is expected to pursue the FDA 505(b)(2) regulatory pathway, alongside equivalent international approval routes. In plain terms, this pathway allows Patrys to leverage the extensive existing clinical and safety data already compiled for Quetiapine while generating only the new data specific to the RLS-2202 IV formulation. This approach reduces both development risk and the time required to reach regulatory approval compared to a conventional new drug application.
RLS-2202 complements Patrys’ core deoxymab antibody platform and represents an additional value-creating program within the company’s development pipeline. For investors, the 505(b)(2) pathway offers a de-risked route to regulatory approval by building on a known drug’s existing data package rather than starting from scratch.
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What comes next for the RLS-2202 program
With CMAX and Alithia now in place, Patrys has outlined the following forward-looking milestones for the Phase 1A program:
- Finalisation of the clinical trial protocol
- HREC application submission, targeted Q2 CY2026
- Regulatory and ethics submissions and site initiation at CMAX
- First participant dosing, targeted Q3 CY2026, subject to HREC approval
| Milestone | Organisation Responsible | Target Timing | Status |
|---|---|---|---|
| Clinical trial site and CRO appointments | Patrys / CMAX / Alithia | Completed May 2026 | Complete |
| Finalisation of clinical trial protocol | Patrys / Alithia / CMAX | Q2 CY2026 | In progress |
| HREC application submission | Patrys / Alithia | Q2 CY2026 | Pending |
| First participant dosing | CMAX | Q3 CY2026 | Subject to HREC approval |
Patrys has committed to continuing updates on trial initiation timelines and regulatory submissions as the Phase 1 program progresses. All forward-looking milestones remain subject to approvals, consistent with the company’s own stated guidance.
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