Publication of peer reviewed data
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Alderley Park, UK - 11 November 2024: TheraCryf plc (AIM: TCF), the clinical stage drug development company focussing on oncology and neuropsychiatry announces publication of the pharmacokinetic and safety/tolerability data on lead clinical asset SFX-01 from its Ph1b healthy volunteer study in the peer reviewed journal, Advances in Therapy.
The publication, which can be found here, reports on the findings of the study which aimed to investigate how the new SFX-01 enteric-coated tablet formulation performed and how sulforaphane released from the novel formulation was metabolised in the bloodstream of the healthy volunteers and subsequently excreted.
As announced previously in August 2023, the data from the study demonstrated that the Company's new enteric coated tablet formation of lead asset SFX-01 was shown to perform as designed, delivering drug and active metabolites, as well as being safe and well tolerated.
The publication concluded that the data from the phase 1 randomized, double-blinded, placebo-controlled, dose-escalation study demonstrated:
- SFX-01 was well tolerated over 7 days at the doses evaluated, with most side-effects being mild and transient in nature.
- The pharmacokinetic properties of the SFX-01 tablet formulation were in line with expectations, suggesting that enteric coating and stabilization of sulforaphane delivers levels of SFN and metabolites in the range where biological activity is observed.
This publication was authored by TheraCryf's Chief Medical Officer, Dr Glen Clack, and Vice-President, Project Management, Dr Nicholas Mallard, along with consultants to the Company.
Dr Helen Kuhlman, TheraCryf's CBO, commented:
"We are pleased to see our data published in a peer reviewed academic journal. Our study is a definitive examination of sulforaphane's pharmacokinetics from our proprietary enteric coated tablet and provides a detailed analysis of the delivery and handling of sulforaphane from SFX-01 tablets by the body."
Dr Glen Clack, TheraCryf's CMO added:
"These data prepare us well for future studies, in particular glioblastoma patients in our grant funded collaboration with the Erasmus Medical Centre Rotterdam, NL."
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