TheraCryf, a biotech company developing new medicines for addiction and other neuropsychiatric disorders, has announced 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 billion 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 1gm 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.
