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Evgen Covid-19 trial given all-clear on safety and data
11th Mar 2021 15:12
(Sharecast News) - Clinical stage drug development company Evgen Pharma announced on Thursday that after a review of the first 60 patients enrolled, the data safety monitoring committee for the 'STAR' Covid-19 trial had concluded that there were no concerns over patient safety or data quality that would prevent its continuation.
The AIM-traded firm said the phase 2 and 3 trial is a double blind, randomised, placebo-controlled study of its lead asset, 'SFX-01', in patients with acute respiratory distress syndrome.
It said the trial was co-sponsored by the University of Dundee and NHS Tayside, and funded by the UK charity LifeArc.
The trial was investigating whether SFX-01 could reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with suspected Covid-19.
Patients could be included in the study if they were infected with SARS-CoV-2, or other respiratory infections causing community-acquired pneumonia.
Following the positive step, the board said the next event in the trial would involve an assessment of safety and futility by the data monitoring committee of unblinded data on the first 100 patients treated.
In addition to the committee safety and futility assessment, the University of Dundee had decided to review the top-level unblinded data in a preliminary assessment of possible efficacy.
That could lead to adjustments to the design of the trial for remaining patients, including inpatient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy.
It was expected that the initial data would be available during the second quarter.
Evgen said completion of recruitment to the STAR trial was expected at the end of 2021 or early 2022, assuming there were no substantial changes in the total patients to be recruited.
"We are pleased with the conclusion of the data monitoring committee with regard to safety and data quality in the STAR Covid-19 study," said chief executive officer Dr Huw Jones.
"The former conclusion reinforces what we know about the positive safety and tolerability of SFX-01 from previous studies and the latter is yet another testament to the excellent work carried out by professor James Chalmers and his colleagues at Dundee under challenging circumstances."
At 1427 GMT, shares in Evgen Pharma were down 2.38% at 8.01p.
The AIM-traded firm said the phase 2 and 3 trial is a double blind, randomised, placebo-controlled study of its lead asset, 'SFX-01', in patients with acute respiratory distress syndrome.
It said the trial was co-sponsored by the University of Dundee and NHS Tayside, and funded by the UK charity LifeArc.
The trial was investigating whether SFX-01 could reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with suspected Covid-19.
Patients could be included in the study if they were infected with SARS-CoV-2, or other respiratory infections causing community-acquired pneumonia.
Following the positive step, the board said the next event in the trial would involve an assessment of safety and futility by the data monitoring committee of unblinded data on the first 100 patients treated.
In addition to the committee safety and futility assessment, the University of Dundee had decided to review the top-level unblinded data in a preliminary assessment of possible efficacy.
That could lead to adjustments to the design of the trial for remaining patients, including inpatient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy.
It was expected that the initial data would be available during the second quarter.
Evgen said completion of recruitment to the STAR trial was expected at the end of 2021 or early 2022, assuming there were no substantial changes in the total patients to be recruited.
"We are pleased with the conclusion of the data monitoring committee with regard to safety and data quality in the STAR Covid-19 study," said chief executive officer Dr Huw Jones.
"The former conclusion reinforces what we know about the positive safety and tolerability of SFX-01 from previous studies and the latter is yet another testament to the excellent work carried out by professor James Chalmers and his colleagues at Dundee under challenging circumstances."
At 1427 GMT, shares in Evgen Pharma were down 2.38% at 8.01p.