Australian partner to progress Ox-1 Phase 1 trial
2 October 2026
TheraCryf plc
("TheraCryf", the "Company" or the "Group")
Australian partner appointed to progress Ox-1 towards 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.
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Enquiries
TheraCryf plc
Dr Huw Jones, CEO
Toni Hänninen, CFO
Dr Helen Kuhlman, COO
+44 (0)1625 315 090
Singer Capital Markets (NOMAD & Joint Broker)
Russell Cook / Alex Bond
+44 (0)20 7496 3000
Turner Pope Investments (Joint Broker)
Guy McDougall / Andy Thacker
+44 (0)20 3657 0050
Northstar Communications (Investor Relations)
Sarah Hollins
+44 (0)113 730 3896
sarah@northstarcommunications.co.uk
About TheraCryf
TheraCryf plc is a biotechnology company developing new medicines for addiction and other neuropsychiatric disorders, areas of significant unmet medical need.
The Group’s lead programme is a novel, best-in-class orexin-1 receptor antagonist being developed as a potential treatment for addiction, including binge eating, alcohol and other substance use disorders.
The programme has already been heavily de-risked for both safety/tolerability and efficacy in previous testing and is fully funded through final pre-clinical trials to clinical readiness, with regulatory submissions for first in man studies targeted for 2026.
TheraCryf also has a dopamine transporter (DAT) modulator programme addressing fatigue of brain origin, including fatigue associated with multiple sclerosis, chemotherapy and narcolepsy. The Group also has a legacy, grant-funded, oncology programme in glioblastoma with SFX-01.
The Group operates a capital-light, virtual development model advancing programmes to early clinical or proof-of-concept stage before partnering with commercially focused pharmaceutical and biotechnology companies.
TheraCryf’s headquarters and registered office are at Alderley Park, Cheshire.
For further information, visit: https://theracryf.com
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