Update on Data Safety Review - STAR COVID-19 trial

RNS Number : 8634R

Evgen Pharma PLC

11 March 2021

 

Evgen Pharma plc

  ("Evgen" or the "Company")

Update on Data Safety Review for STAR COVID-19 trial

Review of Patient Safety and Data Quality confirms no concerns with trial

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces that after a review of the first 60 patients enrolled, the Data Safety Monitoring Committee ("DMC") for the STAR COVID-19 ("SFX-01 Treatment for Acute Respiratory infections") trial has concluded that there are no concerns regarding patient safety or data quality that would prevent continuation of the trial.

The Phase II/III trial is a double blind, randomised, placebo-controlled study of the Company's lead asset, SFX-01, in patients with acute respiratory distress syndrome (''ARDS''). The trial is co-sponsored by the University of Dundee and NHS Tayside and funded by the UK charity LifeArc. It is investigating whether the Company's lead asset, SFX-01, can reduce the severity, or prevent the onset of, acute respiratory distress syndrome in patients with suspected COVID-19. Patients may be included in the study if they are infected with SARS-CoV-2 or other respiratory infections causing community-acquired pneumonia.

Following this positive step, the next event in the trial involves an assessment of safety and futility by the DMC of unblinded data on the first 100 patients treated. In addition to the DMC safety and futility assessment, Dundee University has decided to review the top-level unblinded data in a preliminary assessment of possible efficacy. This may lead to adjustments to the design of the trial for remaining patients, including in-patient numbers, and possibly early termination for either safety, futility or alternatively, strong efficacy. It is expected that this initial data will be available during Q2 of the calendar year 2021.

Completion of recruitment to the STAR trial is anticipated at the end of 2021/early 2022, assuming there are no substantial changes in the total patients to be recruited. 

Dr Huw Jones, CEO of Evgen, commented : "We are pleased with the conclusion of the data monitoring committee with regard to safety and data quality in the STAR COVID 19 study. 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."

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
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]
Anna Dunphy / Paul McManus		[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  

 

END

 

 

UPDBRGDXRXBDGBG