9th Jul 2021 11:51
(Alliance News) - Evgen Pharma PLC halted its Star Covid-19 study on Friday, after its SFX-01 treatment failed to achieve a statistically significant improvement in patients.
Interim analysis of data from 133 total pneumonia patients - treated with the company's lead asset, SFX-01, plus standard care - found that "active treatment would not be likely to show an overall statistically significant improvement".
In response Friday morning, shares in Evgen Pharma were trading down 30% at 5.19 pence each in London.
Having failed to overcome its interim futility hurdle, the Liverpool, England-based company said it would not continue to recruit patients for the trial.
Evgen noted that despite the efficacy failure of the treatment: "There were no safety issues observed relating to active treatment."
The trial was designed to address the lung damage - known as Acute Respiratory Distress Syndrome - associated with Covid-19, which requires patients to be placed on a ventilator until the lungs can heal.
Evgen and its partners at the University of Dundee proposed that a stable form of sulforaphane, SFX-01, could stimulate production of a naturally occurring protein, Nrf2, that defends the body against inflammatory and oxidative stress.
Chief Executive Huw Jones, said: "We are surprised and disappointed by these findings given the strong preclinical hypothesis surrounding sulforaphane as an Nrf2 activator with potential direct antiviral properties...We will continue to work with the University of Dundee on full data analysis of active treatment versus placebo on disease-related endpoints and biomarkers so that we can learn from this important work."
In light of this unwelcome outcome, Evgen noted that the SFX-01 drug was produced in response to immediate circumstances and that its financial contribution to date was "not significant".
The company said it would remain focused on its core oncology programmes in future, including clinical studies of cells from patients that have developed a resistance to the widely used class of CDK4/6 inhibitors.
By Scarlett Butler; [email protected]
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