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Positive Ox-1 tox data in addiction programme
TheraCryf plc announced positive top-line data from the first toxicology species in its lead Ox-1 addiction program, with the drug well-tolerated at doses 100 times the expected human therapeutic use, exceeding FDA safety margin requirements. Clinical trial enabling work is progressing ahead of schedule, with manufacturing scale-up complete and a patent application submitted for improvements. The company is on track to submit its clinical trial application data in 2026, a significant value inflection point, and is attracting interest from potential partners, with Phase 1 clinical stage assets attracting up-front payments of US$26 million to US$49 million. Disclaimer*
About this update from Theracryf Plc
[{"type":"text","content":"\n\n\n \n \n14 May 2026\nTheraCryf plc\n(\"TheraCryf\", the \"Company\" or the \"Group\")\n \nPositive top line data from first toxicology species in lead Ox-1 addiction programme\n \nClinical trial enabling work progressing ahead of plan\nOn track to deliver the major value infection point of all clinical trial application data in 2026\nProgress to date is attracting incoming interest from potential partners\nPhase 1 clinical stage assets attract up-front payments in the range US$26m-US$49m1\n \nTheraCryf plc, the biotech company developing new medicines for addiction and other neuropsychiatric disorders, is pleased to announce that dosing of the first toxicology species in the Ox-1 blocker clinical trial enabling work completed in early May and initial analysis shows that it is well tolerated at very high doses.\nTheraCryf's Ox-1 blocker is aimed at treating substance use disorders, a market already valued at over US$70bn2 per annum. Preclinical data has shown that the Ox-1 blocker has potential class leading performance including proof-of-efficacy in a rodent model of binge eating disorder. \n \nThe clinic enabling programme was fully funded in May 2025 to deliver the data to support an application for Phase 1 human clinical trials before the end of 2026. The key outstanding work packages required to make this application were:\n \n1. Drug manufacturing improvements and scale-up\n2. Development of the methods of analysis for animal and human clinical samples\n3. Toxicology studies in two species\n \nThe Company has now successfully scaled-up manufacturing and produced over 2Kg of drug that can be used in human trials. Improvements in the manufacturing process have led to a manufacturing patent application being submitted which, when granted, will provide considerable increased commercial protection until 2046, increasing the value of future licensing deals.\n \nDosing is now complete in the rodent toxicology study, and using the analysis methods that have been developed, initial analysis shows that the drug is well tolerated at doses up to 100 times the expected requirements for human therapeutic use, which is well in excess of the tenfold safety margin requirements in the FDA guidelines.\n \nAll remaining activities a...