Business
Key Ox-1 milestone & notice of investor webinar
TheraCryf plc has achieved a significant milestone in its Ox-1 orexin blocker program for addictive disorders, successfully scaling up drug substance manufacturing to produce 10.6kg, exceeding target yield and on schedule to supply critical 28-day toxicology studies commencing in Q1/Q2 2026. These studies, expected to complete in Q3 2026, are the final major hurdle before a planned regulatory submission later in the year, with maximum tolerated dose studies now underway. The company will host an investor webinar on January 8, 2026, to discuss progress and future milestones. Disclaimer*
About this update from Theracryf Plc
[{"type":"text","content":"\n\n\n \nTheraCryf plc\n(\"TheraCryf\", the \"Company\" or the \"Group\")\n \nOx-1 addiction programme advances closer to clinical readiness on achievement of key milestone\nand\nNotice of investor webinar\nManufacturing of drug substance successfully scaled up to supply 28-day toxicology studies\nAlderley Park, 5 January 2026 - TheraCryf plc (AIM: TCF), the clinical stage drug development company focussing on brain disorders, has started 2026 positively, achieving a key milestone on the path to clinical readiness for its Ox-1 orexin blocker potential treatment for addictive disorders.\n· Process for large-scale manufacturing of drug substance established\n· Scale-up achieved on schedule with a manufacturing yield in excess of target\n· 10.6kg produced to supply critical 28-day regulatory toxicology studies\n· Dosing in two species has now commenced to identify maximum tolerated dose for 28-day regulatory toxicology studies\n· These studies will begin in Q1/2 2026, depending on species\n· All studies on schedule to complete Q3 2026\nManufacturing scale-up and completion of 28-day toxicology studies were highlighted, during the successful placing in March 2025, as the two key milestones remaining in the Ox-1 programme to achieve clinical readiness. Scale-up of the Ox-1 compound to 10kg has now been achieved on schedule and with a yield in excess of expectations.\nThis drug substance will be used in the 28-day regulatory toxicology studies scheduled to commence, in Q1 and Q2, this year in two species. These studies will provide essential data for the planned regulatory submission later in the year and represent the last major hurdle to achieving that goal.\nBefore starting the 28-day toxicology studies, the Maximum Tolerated Dose and Dose Range Finding studies need to be completed. This work has now started. These studies will identify the 'therapeutic index' of the orexin-1 blocker - that is the range between which the dose is expected to have a therapeutic effect and the highest dose of compound reached before any harmful effects are observed.\nOx-1 is TheraCryf's lead asset, an orexin-1 blocker, being developed as a potential treatment for addiction, blocks a pathway in the brain (orexin-1) known to be over-active...