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Patrys (ASX:PAB) has started key manufacturing and regulatory activities for the advancement of RLS-2201, the company’s proprietary injectable formulation of Quetiapine being developed to alleviate delirium.
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Delirium is described as an acute, fluctuating state of severe confusion, reduced awareness, and cognitive impairment that develops rapidly (hours to days).
A study by the Australian Delirium Association found that there are more than 130,000 cases of delirium each year in Australia, and the total estimated cost of the impairment was $8.8 billion per year.
Delirium affects between 30 to 70% of intensive care patients and currently lacks a rapid-acting injectable therapy approved for acute treatment.
RLS-2201 is a proprietary injectable formulation of Quetiapine, designed for use in acute care settings, to provide rapid, predictable and effective treatment of delirium.
CEO, Dr Samantha South, said by reformulating a well-established therapeutic agent into an injectable formulation suitable for acute hospital use, Patrys aims to address a significant unmet clinical need in the management of delirium.
“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,” she explained.
“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.”
The program is now expected to pursue a regulatory pathway, alongside and equivalent international approval routes, allowing the company to leverage the extensive existing clinical and safety data for Quetiapine while generating new data specific to the RLS-2201 formulation.
Dr South said this regulatory approach provides the opportunity to accelerate clinical development timelines relative to traditional drug development programs.
“RLS-2201 complements Patrys’ core antibody platform and represents an additional value-creating program within the company’s development pipeline.”
The company has initiated engineering batch manufacturing of RLS-2201 at BioCina, an Australian contract development and manufacturing organisation (CDMO) specialising in sterile injectable drug product formulation development and manufacturing, from clinical trial to commercial scale-up capacity.
The engineering batch represents the first production run of the reformulated product under conditions designed to replicate commercial-scale manufacturing processes.
PAB is steady at 3.4c.
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