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Final Report from Phase 1b PK/PD study
Final Report from Phase 1b PK/PD study.
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[{"type":"text","content":"\n\n \nEvgen Pharma plc\n(\"Evgen\" or \"the Company\" or \"the Group\")\n \nFinal Clinical Study Report from Phase 1b PK/PD study of new SFX-01 tablet formulation approved\n \nNew formulation of SFX-01 performs as designed, delivers meaningful levels of drug and metabolites, is safe and well tolerated\n \nResults to be shared with Evgen Partner, Stalicla in support of regulatory\nsubmissions for Phase 2 studies in Autism Spectrum Disorder\n \nAlderley Park, UK - 15 August 2023: Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane-based medicines, reports the final data from its Phase 1b healthy volunteer study using the Company's new enteric coated tablet formation of lead asset SFX-01. The data are contained in the extensive Clinical Study Report (CSR) which has been approved by the Company and its providers in compliance with good clinical practice (GCP).\n \nFollowing the top-level data announced in March 2023, the full pre-specified pharmacokinetic (PK) and pharmacodynamic (PD)* dataset from the placebo-controlled, dose-escalating, randomised study has now been analysed and reported in the approved CSR. The study aimed to investigate how sulforaphane released from the new enteric-coated tablet formulation was absorbed from the intestine and its effects on the physiology of healthy volunteers. \n \nHighlights\n· As reported in March 2023, based on the time course seen, sulforaphane was released by the new enteric coated tablet beyond the acid environment of the stomach\n· No serious adverse events were observed\n· Total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range, where efficacy is seen in vitro\n· Additional pharmacodynamic exploratory investigation, utilising mRNA sequencing, showed changes in gene expression after dosing with SFX-01 even in healthy volunteers\n \nIn addition to the biomarkers analysed in the study and contained within the CSR, changes in gene expression were measured by mRNA sequencing on participants' blood, for placebo and SFX-01 treated subjects that received 600mg once daily. The initial analysis identified a large number of significant differentially expressed genes in the SFX-...