Evgen Pharma plc (AIM: EVG), the clinical stage drug development company, is delighted to announce participation in the recently notified funding initiative for COVID-19 clinical trials by the medical research charity, LifeArc.
Under this scheme Evgen’s lead product candidate, SFX-01, has been selected for evaluation in a randomised Phase II/III trial to be sponsored by the University of Dundee (”Dundee”). The trial will investigate whether SFX-01 can reduce the severity, or prevent the onset of, acute respiratory distress syndrome (“ARDS”) associated with COVID-19, thus reducing the need for invasive patient ventilation and potentially improving recovery times.
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 patients which can result in the need for invasive ventilation in an intensive care unit.
The trial is being led by Professor James Chalmers, British Lung Foundation Professor of Respiratory Research at the University of Dundee. The study will recruit up to 300 patients with confirmed or suspected COVID-19 from hospitals across the UK. Half the group will receive SFX-01 in addition to standard hospital care while the other half will receive a placebo and standard hospital care. The study is expected to begin enrolment in July, and 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.
The clinical study is being supported by a grant from LifeArc, as part of its activities to address the need for new therapies for COVID-19. LifeArc has made £10m available to repurpose existing medicines or those in the late stage of development, as this approach offers one of the fastest routes to develop new treatments that could tackle the virus and its impact. LifeArc received more than 130 in-scope applications from around the globe for this scheme and an independent panel of experts assessed shortlisted applications selected on a number of criteria including scientific rationale of approach.
Professor James Chalmers, Principal Investigator on the trial, said : “SFX-01 is an anti-inflammatory medication that we believe may have the potential to reduce some of the worst outcomes of COVID-19. Early treatment with an Nrf2 activator in patients hospitalised with COVID-19 may prevent deterioration and help to preserve precious ICU resources in the context of the pandemic. This is a completely new mechanism as there is currently no drug that targets Nrf2.”
Barry Clare, Executive Chairman of Evgen, said: ”We are delighted to be supporting Dundee University in this trial which we fervently hope will lead to an additional treatment for COVID-19 patients. We are excited that, as a proven activator of the Nrf2 pathway, SFX-01 could be of significance in the COVID-19 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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