Interim Safety and Futility Analysis - STAR trial
9 July 2021
Evgen Pharma plc
("Evgen" or the "Company")
Interim Safety and Futility Analysis, STAR COVID-19 Study
Evgen Pharma plc (AIM: EVG), a clinical stage drug development company, announces the results of the interim safety and futility assessment readout of the first 100 patients treated in the STAR COVID-19 ("SFX-01 Treatment for Acute Respiratory infections") trial.
The double blind, randomised, placebo-controlled Phase II/III trial was to assess the Company's lead asset, SFX-01, plus standard care in patients initially hospitalised with community acquired pneumonia (including patients investigated for suspected COVID19 infection). The trial has been co-sponsored by the University of Dundee and NHS Tayside and funded by the UK charity LifeArc. An interim analysis of the efficacy and safety data on the first 100 patients who received SFX-01 or placebo was reviewed by an independent data management committee, and this was extended to incorporate the full 133 patients recruited to date. Evgen was informed this week that the committee had concluded the analyses did not meet the interim futility hurdle required to continue the study, and that active treatment would not be likely to show an overall statistically significant improvement. Recruitment into the trial will therefore be halted. Importantly there were no safety issues observed relating to active treatment, further underlying the excellent safety profile of SFX-01.
The original hypothesis was that upregulation of the transcription factor Nrf2 would lead to reduction of the severity of respiratory disease. This will be investigated further as part of a deeper analysis of the full unblinded clinical and biomarker data set, including an assessment of the association of variables such as patient demographics and changes in standard treatment options over time. These results will be reported in due course.
Dr Huw Jones, CEO of Evgen, commented : "We are surprised and disappointed by these findings given the strong preclinical hypothesis surrounding sulforaphane as an Nrf2 activator with potential direct antiviral properties. Following this readout, we will continue to work with the University of Dundee on full data analysis of active treatment versus placebo on disease-related endpoints and biomarkers so that we can learn from this important work. It is reassuring that there were no safety issues related to active treatment with SFX-01 and the study provides further safety and drug exposure data in a substantial number of seriously ill patients.
"The Company mounted a rapid and important response to the current pandemic advised by colleagues in Dundee. From our point of view, the programme was always opportunistic and driven by urgent clinical need. The financial contribution from Evgen was not significant and we reiterate that our core programmes remain oncology focused. Complementing our positive phase 2 clinical data in metastatic breast cancer we have recently reported further positive data in cells derived from patients who had developed resistance to the widely used class of CDK4/6 inhibitors. We have also recently reported compelling data in pre-clinical models in glioblastoma from two academic centres. The Company is extremely well funded and we look forward to updating the market further as our oncology data sets strengthen and will continue to pursue attractive commercial opportunities for SFX-01."
The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.
Enquiries:
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Evgen Pharma plc www.evgen.com |
via Walbrook |
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Dr Huw Jones, CEO |
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Richard Moulson, CFO |
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finnCap www.finncap.com |
+44 (0)20 7220 0500 |
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Geoff Nash / Teddy Whiley (Corporate Finance) |
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Alice Lane (ECM) |
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Walbrook PR |
+44 (0)20 7933 878 or evgen@walbrookpr.com |
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Anna Dunphy / Paul McManus |
+44 (0)7876 741 001 / +44 (0)7980 541 893 |
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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 has its headquarters at Alderley Park, 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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