Evgen Pharma PLC (EVG.L) All approvals received for STAR trial to commence

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, is pleased to announce that all necessary regulatory approvals have now been received for the STAR trial (SFX-01 treatment for Acute Respiratory Infections). Trial recruitment is expected to commence around the end of the month.

STAR is a Phase II/III trial to 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 suspected COVID-19. Patients may therefore be drawn from both hospital and community settings and may present with C OVID -19 or other respiratory diseases. It is a randomised, placebo-controlled trial and is sponsored by the University of Dundee.

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 reduces 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.

The clinical study is being supported by a grant from LifeArc, as previously announced in June 2020, and is being led by Professor James Chalmers, British Lung Foundation Professor of Respiratory Research at the University of Dundee. The results are expected in 2021.

Evgen will supply clinical centres with SFX-01 and a placebo as its contribution to the trial. No additional financing is required as the costs of providing SFX-01 for the trial are not material.

Dr Huw Jones, Evgen CEO, commented: “Receiving full regulatory approval is a significant step forward for us. We look forward to the start of recruitment for the trial shortly with our partner. We hope that the outcome of this trial will lead to an additional treatment for COVID-19 patients and that SFX-01 could play a big part in managing the current pandemic.”

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

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.


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