TheraCryf plc (AIM: TCF), a UK-based biotech company that develops new medicines for addiction and other neuropsychiatric disorders, announced on Monday that it has completed preclinical dose range finding studies for its lead orexin-1 (Ox-1) receptor antagonist programme, advancing the candidate towards final toxicology testing ahead of a first-in-human Phase 1 clinical study. The programme, targeting addiction, remains on track for clinical readiness by Q4 2026.

The Ox-1 blocker was well tolerated at doses of up to 1g per 1kg of body weight, the highest level permitted by regulators in such studies. The results align with data from other Ox-1 and dual Ox-1/2 antagonists that have achieved full marketing approval. Dose levels have now been selected for the pivotal 28-day toxicology studies, which are expected to commence shortly, with final reporting scheduled for Q3 2026.

Positioned as a potential best-in-class treatment for addiction, including binge eating, alcohol and substance use disorders, the Ox-1 programme has been de-risked through prior safety, tolerability and efficacy testing. The programme is fully funded through to clinical readiness, with regulatory submissions for first-in-human studies targeted in 2026.

TheraCryf is focused on developing treatments for addiction and other neuropsychiatric disorders, addressing significant unmet need in central nervous system conditions. In addition to its lead programme, the company is progressing a dopamine transporter modulator targeting fatigue associated with conditions such as multiple sclerosis, chemotherapy and narcolepsy, alongside a grant-funded oncology programme in glioblastoma.