TheraCryf appoints Australian partner for addiction treatment trial
Biotech company TheraCryf has appointed Avance Clinical to support regulatory preparations for its first human trial of an addiction treatment.
The Australian contract research organisation will support TheraCryf’s application to a Human Research Ethics Committee and the subsequent Clinical Trial Notification to Australia’s Therapeutic Goods Administration.
Avance Clinical was selected following a competitive process.
TheraCryf expects to complete the remaining clinic-enabling documentation in the fourth quarter of 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.
The company is developing Ox-1, a selective orexin-1 receptor antagonist, 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 fourth quarter 2026.
Earlier this week CEO, Dr Huw Jones, said the company had delivered strong progress over the past year including a fund raising.
He added: “The successful completion of our recent £1.05m fundraising provides the resources to complete the remaining clinic-enabling activities required to seek approval to commence a Phase 1 study in Australia and extends our cash runway to the end of the first quarter of 2027.”
