Patient recruitment update in STAR-COVID 19 trial

RNS Number : 0902M

Evgen Pharma PLC

19 January 2021

 

Evgen Pharma plc

  ("Evgen" or the "Company")

Update on patient recruitment in STAR-COVID 19 trial

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").

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 with 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.

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.

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.

Dr Huw Jones, CEO of Evgen, commented: "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 the market as we progress through this important trial.''

The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.

Enquiries:

Evgen Pharma plc www.evgen.com		via Walbrook
Barry Clare, Chairman Dr Huw Jones, CEO
Richard Moulson, CFO
finnCap www.finncap.com		[phone]
Geoff Nash / Teddy Whiley (Corporate Finance)
Alice Lane (ECM)
Walbrook PR	[phone] or [e-mail]
Paul McManus / Anna Dunphy		[phone] / [phone]

About Evgen Pharma plc  

Evgen Pharma is a clinical stage drug development company developing sulforaphane based medicines for the treatment of multiple diseases. The Company's core technology is Sulforadex®, a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.

Clinical data from the Company's open-label Phase II STEM trial has shown that SFX-01 can halt the growth of progressing tumours in patients with oestrogen-positive (ER+) metastatic breast cancer, and in some cases significantly shrink the tumour, whilst causing very few side effects.

The Company commenced operations in January 2008 and has its headquarters at The Colony, Wilmslow, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.  

For further information, please visit:  www.evgen.com  

 

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