The Evgen Pharma PLC (LON: EVG) share price rallied 12.9% after releasing the final data from its Phase 1b study conducted on healthy volunteers using the company’s new enteric-coated tablet formulation of its lead asset SFX-01.
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The data was published as an extensive Clinical Study Report (CSR), which the company and its providers approved since it was created in compliance with good clinical practice (GCP). The report comes after the top-level data was announced in March 2023.
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The Clinical Study Report contains the full pre-specified pharmacokinetic (PK) and pharmacodynamic (PD)* dataset from the placebo-controlled, dose-escalating, randomised study, analysed and reported in the approved CSR.
The Phase 1b study’s primary aim was 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.
As the March data showed, sulforaphane was released by the new enteric-coated tablets beyond the stomach’s acid environment. There were no serious adverse effects witnessed in the healthy volunteers. The total blood levels of sulforaphane (SFN) and SFN-metabolites were confirmed in the micromolar range.
Further, pharmacodynamic exploratory investigation using mRNA sequencing showed changes in gene expressions after dosing with 600mg daily of SFX-01 in healthy volunteers as opposed to those on a placebo.
The company will further analyse the large and complex dataset to gain insight into the identified genes.
Dr Huw Jones, Evgen Pharma’s CEO, said: “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. 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 (ASD).”
Dr Glen Clack, Evgen Pharma’s CMO, added: “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.”
The Evgen Pharma (EVG) share price.
The Evgen Pharma share price rallied 12.92% to trade at 2.71p, from Monday’s closing price of 2.40p.
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