Patrys Secures Key Partners for RLS-2202 Phase 1A Trial Targeting Q3 2026 Start

Strategic Appointments Propel RLS-2202 Toward Clinical Trials

Patrys Limited (ASX:PAB) has taken a decisive step forward in its quest to develop an injectable quetiapine formulation for delirium by appointing two key partners ahead of its Phase 1A clinical trial. The company has engaged CMAX, a specialist Phase 1 clinical unit in Adelaide, as the trial site, and Alithia Life Sciences as its Contract Research Organisation (CRO) to oversee trial management and regulatory compliance. These appointments mark a critical operational milestone that sets the stage for first participant dosing targeted for Q3 2026, contingent on Human Research Ethics Committee (HREC) approval.

CMAX Brings Early-Stage Expertise and Infrastructure

CMAX’s selection follows a competitive evaluation process, reflecting its strong track record in early-stage and first-in-human studies across diverse therapeutic areas. As the physical location for the trial, CMAX will provide specialist infrastructure, experienced investigators, and participant recruitment capabilities essential for the bridging study assessing safety, tolerability, and pharmacokinetics in healthy volunteers. This aligns with Patrys’ strategy to leverage established clinical expertise and accelerate trial execution timelines.

Alithia Life Sciences to Manage Trial Oversight and Quality

Alithia Life Sciences will coordinate the broader operational, regulatory, and clinical oversight aspects of the Phase 1A trial. Its responsibilities include project management, regulatory liaison, data management, pharmacovigilance, and ensuring adherence to Good Clinical Practice (GCP) standards. The CRO’s involvement is designed to deliver high-quality data and robust safety monitoring, which are critical for reliable interpretation of pharmacokinetic and tolerability results. Founder A/Prof Tina Soulis expressed enthusiasm about supporting an Australian company advancing innovative therapies.

On Track for Q3 2026 Trial Commencement

Following these appointments, Patrys will finalise the clinical trial protocol and submit its HREC application in Q2 2026. Subject to approval, dosing is expected to commence in Q3 2026. This timeline dovetails with prior announcements of manufacturing readiness and regulatory de-risking activities, including a recent $3.2 million capital raise to fund clinical and regulatory milestones. The Phase 1A study represents a foundational step in Patrys’ broader strategy to bring RLS-2202 through clinical development efficiently.

RLS-2202 Targets Unmet Need in Delirium Treatment

RLS-2202 is a proprietary intravenous formulation of quetiapine designed to deliver rapid and predictable treatment for delirium in acute care settings. Patrys intends to pursue the FDA 505(b)(2) regulatory pathway, leveraging existing safety data for quetiapine while generating new data specific to the injectable formulation. This approach aims to shorten development timelines and reduce costs compared to novel drug discovery, as previously outlined in the company’s strategy to tap into the substantial delirium market valued at over US$2 billion injectable quetiapine reformulation. The program complements Patrys’ antibody deoxymab platform, diversifying its clinical-stage portfolio.