RLS-2202 is a proprietary injectable formulation of an approved atypical antipsychotic drug, quetiapine, which has been optimised for use in acute care settings for delirium, a clinical term for a period of intense and often distressing and dangerous confusion.
Delirium is an acute neurocognitive condition characterized by confusion, disorientation and altered behaviour. Delirium is essentially a “chemical storm” in the brain. The normal balance between calming and activating brain signals becomes scrambled which makes processing information very difficult. Delirium has a wide range of causes including infections, metabolic disturbances, dehydration, organ failure, drug withdrawal, pain and recovery from anaesthesia, among others.
Delirium affects a significant proportion of critically ill, elderly and palliative-care patients, where there are no approved acute-care therapies currently available for alleviating delirium. Existing off-label therapies have safety concerns, slow onset, or inconsistent efficacy, leaving a gap for a fast-acting injectable option.
Experiencing delirium is distressing and can be dangerous for both patients and healthcare workers, impacting care. Furthermore, extended or repeated episodes of delirium increases the risk of dementia.
Many clinicians consider quetiapine the safest, most effective delirium treatment. Approved for schizophrenia and bipolar disorder, it’s been used safely for decades. Clinical trials show that oral quetiapine, at lower doses, resolves delirium faster with minimal side effects. However, its use in delirium is limited by only being available orally.
Our initial commercial focus is acute care settings- postoperative/ICU (intensive care unit), representing the most immediate and practical entry point for adoption given the prevalence of IV workflows and the limitations of oral therapies.
This positions ICU as the most practical and immediate entry point from both a clinical and adoption perspective.
The global burden of delirium is 148 million episodes annually — a figure built from a pooled 23% prevalence rate across 33 published studies, spanning ICU, general medical wards, postoperative care, aged care, emergency departments, and palliative settings.
Using a bottom-up, very conservative*, approach:
| US$ | ICU | Postoperative | Palliative / hospice | Aged Care | Total |
|---|---|---|---|---|---|
| Annual Patients US | 5,700,000 | 15,000,000 | 800,000 | 1,400,000 | |
| Worldwide (OECD) | 10,281,308 | 40,500,000 | 61,000,000 | 24,000,000 | |
| US revenue | 102,600,000 | 202,500,000 | 14,400,000 | 25,200,000 | 345M |
| OECD revenue | 546,750,000 | 185,063,544 | 1,098,000,000 | 432,000,000 | 2.3B |
*Assumptions include low prevalence (15-20%), treatment rate (30%) and length of treatment (3 days) for delirium.
RLS-2202 is a proprietary injectable formulation of an atypical antipsychotic drug called quetiapine that has been approved since 1997 for oral administration to people diagnosed with schizophrenia or bipolar disorder. As an approved product for these chronic conditions, oral quetiapine is extensively characterized in humans and there is a wealth of mechanism of action, off-target effects, and safety data that already exists. Manufacturing risk is also eliminated. The compound is proven to be scalable to commercial levels.
RLS-2202 offers several advantages over oral quetiapine and other off-label treatments, including rapid onset, reduced variability, lower drug exposure, fewer side effects, and easier dosing which is particularly suited to acutely unwell patients suffering delirium.
The target outcomes of an approved RSL-2202 would be rapid treatment for patients, shorter stays in treatment centers, lower costs of treatment, lower risks of long-term dementia development, and greater safety for patients and staff.
Because so much safety data already exists supporting quetiapine Patrys can benefit from a truncated hybrid/505(b)(2) regulatory pathway, which may take only 18-24 months to move through to the pivotal clinical trials. Generally this pathway takes less time, costs less and has 2-3 x the likelihood of success compared with drugs that have not already been in humans.