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Preliminary results from Phase 1b study
Preliminary results from Phase 1b study.
About this update from Theracryf Plc
[{"type":"text","content":"\n \n \n \n \n \n 22 March 2023\n \n \n \n \n \n \n \n \n Evgen Pharma plc\n \n \n \n (\"Evgen\" or \"the Company\" or \"the Group\")\n \n \n \n \n \n \n Preliminary pharmacokinetic results from Phase 1b study of new SFX-01 tablet formulation\n \n \n \n \n \n \n \n \n \n Delivery of active ingredient beyond the stomach confirmed in a time course consistent with enteric coated tablet release.\n \n \n Clear dose relationship demonstrated and SFX-01 well tolerated across all doses with\n \n \n no\n \n \n serious adverse events.\n \n \n \n \n \n \n \n Alderley Park, UK - 22 March 2023\n \n : Evgen Pharma plc (AIM: EVG), a clinical stage drug development company\n developing sulforaphane-based medicines\n , announces top line pharmacokinetic data of its placebo-controlled, dose-escalating, randomised Phase I/Ib clinical trial.\n \n \n \n \n \n The study aimed to\n provide further insight into the pharmacokinetic and pharmacodynamic characteristics of the new enteric coated (EC) tablet formulation of the Company's lead asset SFX-01, as well as\n investigating how sulforaphane released from the tablet engages with molecular targets of interest. The new form of active ingredient in this SFX -01 tablet has additional patent protection.\n \n \n \n \n \n \n Highlights\n \n \n \n ·\n Sulforaphane was released by the new enteric coated tablet beyond the acid environment of the stomach based on the time course seen, as predicted\n \n \n ·\n Levels of sulforaphane and its active metabolites in blood increased predictably with increasing dose\n \n \n ·\n Total levels of sulforaphane and active metabolites in blood are in the range previously seen to be effective in pre-clinical experiments and clinical studies in a range of target diseases including breast cancer and glioblastoma\n \n \n ·\n No serious adverse events observed\n \n \n ·\n Pharmacodynamic analysis now underway, via highly sophisticated experiments on a longer time scale, focused on how the drug modulates disease-relevant molecular targets and will be reported in due course\n \n \n ·\n The study is on schedule for full reporting in the second quarter of 2023.\n \n \n \n \n \n The new enteric-coated tablet formulation of SFX-01 will replace the previous prototype capsule formulation. It releases sulforaphane to a targeted part o...