Patrys has initiated manufacturing and regulatory steps for RLS-2201, its injectable Quetiapine formulation targeting delirium, aiming for Phase 0 trials in the second half of 2026.
- Engineering batch manufacturing started at BioCina
- US regulatory engagement underway ahead of FDA pre-IND submission
- CRO selection in progress for Phase 0 clinical trial
- Clinical trial initiation targeted for H2 2026
- RLS-2201 leverages existing Quetiapine safety data for accelerated development
Manufacturing Milestone at BioCina
Patrys Limited (ASX:PAB) has taken a significant step forward in developing RLS-2201, its proprietary injectable formulation of Quetiapine designed to treat delirium in acute care settings. The company announced the initiation of engineering batch manufacturing at BioCina, an Australian contract development and manufacturing organisation specialising in sterile injectable drugs. This first production run simulates commercial-scale processes and will generate material for stability testing and early clinical trial use.
This milestone is critical as it de-risks the manufacturing pathway, ensuring reproducibility and readiness for producing Good Manufacturing Practice (GMP) clinical trial material required for the upcoming Phase 0 and Phase I studies.
Regulatory Engagement with US Experts
In parallel with manufacturing, Patrys has engaged Facet Life Sciences, a US regulatory advisory group, to prepare for an FDA pre-Investigational New Drug (pre-IND) submission. This early dialogue aims to leverage the extensive safety and clinical data already available for oral Quetiapine, while tailoring the clinical development strategy and study design for the injectable RLS-2201 formulation.
By aligning with FDA expectations early, Patrys hopes to streamline regulatory approvals and accelerate the clinical trial timeline, a crucial factor given the urgent unmet need for rapid-acting delirium treatments in intensive care units.
Clinical Trial Planning and CRO Selection
The company is also advancing discussions with specialist Contract Research Organisations (CROs) experienced in early-phase trials. These talks cover clinical site selection, patient recruitment strategies, and operational management, with a formal CRO appointment expected by the second quarter of 2026. This will pave the way for the planned Phase 0 trial, marking Patrys’ first-in-human study of RLS-2201.
Addressing a Critical Unmet Need
Delirium affects between 30% and 70% of intensive care patients and currently lacks an approved rapid-acting injectable therapy. Patrys’ approach to reformulate Quetiapine into an injectable form aims to fill this gap, offering predictable and effective treatment in acute hospital settings. The company plans to pursue the FDA’s 505(b)(2) regulatory pathway, which allows leveraging existing clinical data to potentially shorten development timelines.
CEO Dr Samantha South emphasised the strategic importance of these developments, stating that the manufacturing and regulatory progress represent key de-risking steps as Patrys moves toward clinical trials.
Bottom Line?
With manufacturing and regulatory groundwork laid, Patrys is poised to enter clinical trials that could reshape delirium treatment.
Questions in the middle?
- When will the engineering batch manufacturing be completed and validated?
- What are the detailed design and endpoints of the planned Phase 0 clinical trial?
- How will Patrys navigate potential regulatory challenges with the FDA and international agencies?