The study is specifically analysing the company’s new enteric coated tablet formation of the drug
Evgen Pharma – a company developing sulforaphane-based therapies – has issued the final data from its phase 1b healthy volunteer trial of its SFX-01 candidate. The study is specifically analysing the company’s new enteric coated tablet formation of the drug.
The data concerned has been released in an extensive clinical study report (CSR) in compliance with good clinical practice (GCP).
The study aimed to establish how sulforaphane released from the tablet formulation was absorbed from the intestine and its wider impact on the physiology of trial participants.
This new data contains details of the full pre-specified pharmacodynamic and pharmacokinetic dataset from placebo-controlled, randomised, dose-escalating research.
Notably, sulforaphane (SFN) was released by the new enteric coated tablet beyond the acid environment of the stomach. Furthermore, total blood levels of SFN and SFN-metabolites were confirmed in the micromolar range, where efficacy is witnessed in vitro.
Additional pharmacodynamic exploratory investigations, incorporating mRNA sequencing, demonstrated alterations in gene expression after dosing.
Dr Glen Clack, CMO at Evgen, explained: “The pharmacodynamic data generate a number of hypotheses relevant in both oncology and other conditions that we continue to explore. These insights will be used in our grant-funded collaborations with the Erasmus Medical Centre in Rotterdam in glioblastoma and with our partner, Stalicla, in ASD.
“We are very pleased with the results and are eager to move forward to applying the new formulation to future clinical studies using SFX-01.”
Dr Huw Jones, CEO at Evgen, was also optimistic about the results: “The final CSR confirms, as expected, that the new formulation of SFX-01 is safe and well tolerated at multiple doses. It delivers the drug at highly relevant blood levels within the timeframes expected of an enteric coated formulation.
He added: “We are sharing this report with our partner Stalicla SA as part of our collaboration and will be working with them on supporting regulatory submissions for phase 2 trials in autism spectrum disorder.”
Upon completion of the study, all regulatory submissions and clinical trials will be conducted using the new SFX-01 tablet formulation.
Source link
#Evgen #releases #data #SFX01 #trial
