TheraCryf plc (AIM:TCF) has completed GMP manufacture of 2.57kg of human‑grade drug substance for its lead orexin‑1 (Ox‑1) receptor antagonist, a batch the company says is sufficient to support planned Phase 1 studies and avoids further manufacturing delays ahead of first‑in‑human dosing.
The material was produced by TheraCryf (AIM:TCF)’s manufacturing partner three weeks ahead of schedule, at a higher-than-expected yield, and met all quality standards on first pass. The company adds the optimised, scalable process—now the subject of a patent filing—demonstrates robustness and will be used to formulate the final drug product for volunteer dosing.
"Achieving successful GMP manufacture of human-grade Ox-1 drug substance is an important milestone that further de-risks the programme as we move towards the clinic," said Dr Huw Jones, Chief Executive Officer of TheraCryf.
TheraCryf says completion of the remaining preclinical package, including delivery of 28‑day toxicology study results, remains on schedule for Q3 and is the final step required for a regulatory submission that would enable first‑in‑human studies in 2026. The group is developing Ox‑1 for substance use disorders, which it cites as a market projected to exceed US$70bn by 2035.
