Patrys (ASX:PAB) has commenced key manufacturing and regulatory activities for RLS-2201, a proprietary injectable formulation of Quetiapine aimed at treating delirium.
The condition currently affects between 30% and 70% of intensive care patients, a demographic that lacks an approved, rapid-acting injectable therapy for acute episodes.
By reformulating a well-established therapeutic into an injectable format for hospital use, Patrys intends to address a significant unmet medical need.
A major milestone in this development is the initiation of engineering batch manufacturing at BioCina, an Australian contract development and manufacturing organisation.
The first production run is designed to replicate commercial-scale processes, ensuring the reproducibility of the manufacturing method.
The resulting material will be utilised for essential stability testing and will provide the early supply required for upcoming clinical activities.
On the regulatory front, Patrys has engaged US advisors to prepare for a pre-IND (Investigational New Drug) submission to the FDA.
Simultaneously, the company is in the process of selecting a Contract Research Organisation to manage its first-in-human Phase 0 clinical trial.
The advancements serve as critical de-risking steps for the RLS-2201 program.
CEO Dr Samantha South noted that these activities position the company to remain on schedule for clinical trial initiation in the second half of 2026.
At the time of reporting, Patrys' share price was $0.032.