Key Highlights

  • All four Cohort 1 participants have completed dosing and follow-up in the Phase 1a trial of RLS-2202 in healthy volunteers.
  • The independent Safety Review Committee meets in October 2026, and no decision on progressing to the 12-participant Cohort 2 has been made.
  • Cohort 2 dosing depends on a satisfactory review and quality control release of clinical material, with final dosing targeted for Q4 CY2026.

Patrys Limited (ASX:PAB), a clinical-stage company developing an injectable therapy for delirium alongside a deoxymab platform for immune-mediated inflammatory diseases, announced on 29 September 2026 that all participants in Cohort 1 of the Phase 1a clinical trial of RLS-2202 have completed dosing and the required follow-up period.

Cohort 1 status

Cohort 1 had four participants, all healthy volunteers, who have completed their planned clinical assessments. The study is designed to evaluate safety, tolerability and pharmacokinetics and to generate data to inform dose selection and the next stage of development. No results are reported in the release.

Safety review still outstanding

The company states that, although the participants have completed the planned assessments, the formal Safety Review Committee (SRC) review remains outstanding. The SRC is scheduled to meet in October 2026 to review the safety, tolerability and pharmacokinetic data and recommend the dose for Cohort 2, which has 12 participants, and whether any changes to the dosing regimen or study conduct are needed. No decision on progression to Cohort 2 has been made.

Study design

The Phase 1a is a two-cohort, two-period crossover study comparing intravenous and oral administration, with 16 participants in total. It is conducted at CMAX in Adelaide under the oversight of Alithia Life Sciences, following ethics committee approval and TGA acknowledgement.

Upcoming milestones

The release lists the October 2026 SRC meeting, then, subject to a satisfactory safety review and successful quality control testing and release of the Cohort 2 clinical material, the start of Cohort 2 dosing in Q4 CY2026 and completion of dosing of the final participant in the same quarter. Patrys expects to update the market on progression to Cohort 2 during Q4 CY2026 and as further data become available.

Safety review and dosing details

The SRC's remit includes recommending the Cohort 2 dose and any changes to dosing or study conduct, and Cohort 2 clinical material must pass quality control testing and release before dosing starts. Cohort 2 has 12 participants, three times the size of Cohort 1. The company says it will provide a further update on progression during Q4 CY2026 and will report data as it becomes available.

Company background

Patrys describes itself as developing an injectable therapy for delirium alongside a differentiated deoxymab platform targeting immune-mediated inflammatory diseases. The release includes standard forward-looking statement cautions about estimates, targets and timing. The company directs readers to its InvestorHub for the announcement.