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Patient recruitment update in STAR-COVID 19 trial
Patient recruitment update in STAR-COVID 19 trial.
About this update from Theracryf Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 0902M\n Evgen Pharma PLC\n 19 January 2021\n \n \n \n \n Evgen Pharma plc\n \n \n \n \n \n (\"Evgen\" or the \"Company\")\n \n \n \n \n \n Update on patient recruitment in STAR-COVID 19 trial\n \n \n \n \n \n Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces that as of 18 January, a total of 56 patients had been recruited and randomised to the STAR trial (\"SFX-01 treatment for Acute Respiratory Infections\"). \n \n \n \n \n \n This Phase II/III randomised, placebo-controlled trial is sponsored by the University of Dundee and funded by the UK charity Life Arc. It will investigate whether the Company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome (\"ARDS\") in patients \n with \n community-acquired pneumonia from any infective agent and who have been or are being tested for suspected COVID-19. Patients may therefore present with COVID-19 or other respiratory diseases.\n \n \n \n \n \n The trial design includes an assessment of safety and futility by a Data Safety and Monitoring Board who will review unblinded data on the first 100 patients treated. An announcement will be made when this point has been reached.\n \n \n \n \n \n SFX-01 upregulates the Nrf2 pathway which is part of the natural human defence against inflammatory and oxidative stress, such as the inflammation that occurs during a severe viral infection. Preclinical studies have shown that up-regulating the Nrf2 pathway has the potential to reduce the severity of ARDS, the progressive lung damage observed in COVID-19 and pneumonia patients, which can result in the need for invasive ventilation in an intensive care unit. \n \n \n \n \n \n \n Dr Huw Jones, CEO of Evgen, commented:\n \n \n \"We are pleased with the recruitment progress in this trial and would like to thank Professor James Chalmers and his colleagues at Dundee for their considerable efforts in a difficult clinical environment. We are greatly encouraged by recent academic papers which reinforce previous preclinical data showing the potential benefit to ARDS patients of up-regulating Nrf2 and hope that SFX-01 may be a valuable addition to the array of treatments that these seriously ill patients can receive. We look forward to further updating t...