TheraCryf (LSE:TCF) has appointed Australian contract research organisation Avance Clinical to support regulatory and clinical preparations for a first-in-human Phase 1 trial of its lead Ox-1 programme in Australia.
The appointment follows a competitive selection process and will involve preparing applications for review by an ethics committee, followed by a clinical trial notification to Australia’s Therapeutic Goods Administration.
TheraCryf said it expects to complete the clinic-enabling documentation and obtain the approvals required to begin clinical use of Ox-1 in Australia by the end of 2026. The timetable remains subject to ethics and clinical trial-site approvals.
Ox-1 is a selective orexin-1 receptor antagonist being developed for addiction and related disorders. According to the company, GMP manufacturing of the candidate has been completed, while final toxicology data are nearing completion.
The planned Phase 1 study would represent the first clinical evaluation of Ox-1 in humans.
About TheraCryf
TheraCryf is a UK-based biotechnology company developing treatments for addiction and other neuropsychiatric disorders.
Alongside its lead Ox-1 programme, the company is developing a dopamine transporter modulator for fatigue of brain origin and has a legacy oncology programme targeting glioblastoma.
TheraCryf operates a virtual development model under which it seeks to advance drug candidates through early clinical development or proof-of-concept stages before pursuing partnerships with pharmaceutical and biotechnology companies.
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