TheraCryf (AIM:TCF), the AIM-listed biotech developing medicines for addiction and neuropsychiatric disorders, on Monday announced it has completed and finalised 28-day regulatory toxicology studies in two species for its lead orexin-1 (Ox-1) receptor antagonist.
The results give the company the last preclinical data it needs to apply in November to run a first-in-human Phase 1 trial in Australia.
Ox-1 showed no adverse findings at any dose tested, with the highest dose roughly 70 times the level anticipated for human therapeutic use, well above the tenfold margin regarded as the industry's gold standard for safety.
TheraCryf is raising roughly £1.05m through a placing and subscription agreed in August at 0.18p per share, proceeds earmarked to complete the Ox-1 clinic-enabling work, including the Australian regulatory application, and extend its cash runway to the end of the first quarter of 2027.
The company's Australian subsidiary appointed Avance Clinical, announced on 2 October, to support preparations for ethics review and the subsequent clinical trial notification.
"These toxicology results exceed our expectations and mark an important milestone for our Ox-1 programme," said chief executive Dr Huw Jones, adding that "there is considerable commercial interest in our Ox-1 programme that is waiting to see Phase 1 data."
Read more about TheraCryf
- 20/08/26TheraCryf raises £1.05m to push lead addiction drug to clinic
- 20/04/26TheraCryf manufactures clinical-grade Ox‑1
Chief operating officer Dr Helen Kuhlman said manufacturing optimisation has delivered yields ahead of expectations, alongside new intellectual property with potential patent protection to 2046.
TheraCryf continues to target the necessary Australian regulatory approvals by 31 December, with Jones and Kuhlman due to brief investors on the programme via Investor Meet Company at 1pm on Tuesday, 20 October.