Patrys (ASX:PAB) has taken significant steps toward advancing a potential new treatment for delirium into human clinical trials, including manufacturing and regulatory preparations for its experimental drug candidate RLS-2201.
The company announced that it has begun engineering batch manufacturing of the drug at BioCina, an Australian contract development and manufacturing organisation specialising in sterile injectable medicines. This first production run is designed to replicate future commercial manufacturing conditions and is an important step toward generating material for clinical testing.
The engineering batch will allow the company to confirm the reproducibility of its manufacturing process, produce material for stability studies and generate early supplies that may be used in upcoming clinical trial activities. If successful, the work will enable the manufacture of Good Manufacturing Practice-grade material required for dosing in the company’s planned clinical trial.
At the same time, Patrys has begun engaging US regulatory specialists, Facet Life Sciences, to help prepare for discussions with the US Food and Drug Administration ahead of a future investigational new drug application. The regulatory work is expected to define the clinical development strategy for the injectable formulation, confirm the design of an initial clinical study and prepare the documentation required for ethical and regulatory review.
The company is also progressing with the selection of a contract research organisation to conduct the early-stage clinical trial. Discussions are underway with several groups experienced in first-in-human studies, covering areas such as trial site selection, patient recruitment, clinical operations and regulatory support. Patrys expects to finalise its partner selection during the second quarter of 2026.
Chief executive officer Dr Samantha South said the concurrent progress across manufacturing and regulatory planning represents an important de-risking phase for the program as the company prepares to enter clinical testing. She noted that reformulating a widely used medicine into an injectable therapy designed for acute hospital use could help address a major unmet medical need.
RLS-2201 is an injectable version of quetiapine, a drug already well known in oral form. Patrys is developing the formulation for rapid treatment of delirium in hospital settings, where patients often require fast-acting therapies that can be delivered reliably in intensive care environments. Delirium affects an estimated 30 to 70 per cent of intensive care patients and currently lacks an approved rapid-acting injectable treatment.
The program is expected to follow the FDA’s 505(b)(2) regulatory pathway, which allows developers to rely in part on existing clinical and safety data for an approved drug while generating new data for the reformulated product. This approach can shorten development timelines compared with entirely new drug programs.