Patrys Ltd (ASX:PAB) has begun manufacturing and regulatory activities for RLS-2201, its proprietary injectable quetiapine formulation being developed to treat delirium, as it works toward launching a first-in-human Phase 0 clinical trial in the second half of 2026.
Engineering batch manufacturing had been initiated at BioCina, marking the first production run of the reformulated product under conditions designed to replicate commercial-scale processes. The batch is expected to support manufacturing process validation, stability testing and the production of early material for clinical trial activities.
Successful completion of this stage is intended to pave the way for the manufacture of GMP clinical trial material for Phase I dosing.
Patrys has also started engaging with US regulatory adviser Facet Life Sciences ahead of a planned FDA investigational new drug submission. The discussions are focused on leveraging the existing safety and clinical data for oral quetiapine, defining the development strategy for RLS-2201, confirming the planned Phase 0 study design and preparing regulatory documentation and ethics frameworks.
The company said these steps were aimed at de-risking the program and aligning its development pathway with FDA requirements.
"With manufacturing development underway and regulatory engagement progressing, these activities represent important de-risking steps for the RLS-2201 program as we move toward entering clinical trials," PAB CEO, Dr Samantha South, said.
"By reformulating a well-known therapeutic into an injectable treatment designed for acute hospital use, we believe RLS-2201 has the potential to address a significant unmet need in the treatment of delirium.”
BioCina production run and FDA planning keep delirium program on track for H2 2026
In parallel, Patrys is in advanced discussions with a shortlist of specialist contract research organisations to support early phase trial execution. Those talks cover trial site selection, subject recruitment, clinical operations and regulatory and ethics approval support, with a CRO appointment expected in the June quarter of calendar 2026.
RLS-2201 is being developed as an injectable formulation for acute care settings, where Patrys believes it could address an unmet need in delirium treatment. The company said delirium affects 30-70% of intensive care patients and there is currently no rapid-acting injectable therapy approved for acute treatment.
Patrys expects to pursue the FDA 505(b)(2) pathway, allowing it to leverage existing clinical and safety data for quetiapine while generating new data specific to RLS-2201.