Ox-1 Programme Advances to Final Toxicology Study
TheraCryf plc announced that its lead orexin-1 receptor antagonist programme for addiction has successfully completed preclinical dose range finding studies, with the compound well tolerated at the highest permissible regulatory dose of 1g per 1kg of body weight. These positive results pave the way for the commencement of final 28-day toxicology studies, which are scheduled for completion in Q3 2026, keeping the programme on track for clinic readiness by Q4 2026. This advancement is significant given the US$42 billion substance use disorder market, with projections to reach over US$71 billion in seven years, and is expected to generate considerable commercial interest from larger pharmaceutical companies.
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Programme remains on track for clinic readiness by Q4 2026
TheraCryf plc (AIM: TCF), the biotech company developing new medicines for addiction and other neuropsychiatric disorders, today announces completion of preclinical dose range finding studies for its lead orexin-1 (Ox-1) receptor antagonist programme being developed for addiction, a market worth US$42 billion¹ and an area attracting significant clinical and commercial interest from large pharmaceutical companies.
Dose range finding is an essential step in moving a drug into the clinic that identifies the doses for the pivotal 28-day toxicology study. TheraCryf's Ox-1 blocker was well tolerated at doses up to 1g per 1kg of body weight, the highest that is permissible by regulators in such a study. Findings from this study are consistent with data reported for other Ox-1 and dual Ox-1/2 antagonists that have achieved full marketing approval.
Based on these results, doses have been selected for the pivotal 28-day toxicology studies, the final major pre-clinical studies required for submission for regulatory approval for the first in human clinical study. These studies will commence imminently, with final reporting on schedule in Q3 2026.
Dr Huw Jones, Chief Executive Officer of TheraCryf, commented:
"We continue to deliver a potentially class leading asset on target for clinic readiness in the fourth quarter of this year, exactly in line with the plan outlined at the start of this project. The substance use disorder market is already worth over US$42 billion growing to over US$71 billion¹ over the next seven years.
These conditions cause more deaths than road accidents and substance abusers lose over 20 years of life compared to non-abusers2. The licensing market to large pharma for such treatments is considerable, generating substantial returns to originating companies at the right stage of development. With a class leading profile, we anticipate generating significant commercial interest in TheraCryf's Ox-1 asset."
- Substance Use Disorder Treatment Market Size and Share Forecast Outlook 2025 to 2035. Future Market Insights Inc, November 2025
- Gov.uk and Chan et al Lancet 2023
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