Australian partner to progress Ox-1 Phase 1 trial

TheraCryf plc, the biotech company developing new medicines for addiction and other neuropsychiatric disorders, announces that its wholly owned subsidiary, TheraCryf Australia Pty Ltd, has appointed Avance Clinical Pty Ltd ("Avance Clinical"), a leading global Contract Research Organisation, to support the Australian clinical and regulatory preparations for a first-in-human Phase 1 study of its lead Ox-1 programme.

Avance Clinical was selected following a competitive process. It will support TheraCryf’s preparation of the application to a Human Research Ethics Committee and the subsequent Clinical Trial Notification to Australia’s Therapeutic Goods Administration.

TheraCryf expects to complete the remaining clinic-enabling documentation in Q4 2026 and continues to target approval to proceed with clinical use of Ox-1 in Australia by 31 December 2026, subject to the required ethics and trial-site approvals.

Ox-1 is TheraCryf’s selective orexin-1 receptor antagonist being developed for addiction and related disorders, including binge eating disorder, alcohol use and other substance use disorders. GMP manufacture of the drug substance has been completed, and final GLP toxicology data are expected in early Q4 2026.