Evgen 'surprised and disappointed' by findings in SFX-01 trial

Clinical-stage drug development company Evgen Pharma announced the results of the interim safety and futility assessment readout of the first 100 patients treated in the ‘STAR’ Covid-19 trial of its lead asset, ‘SFX-01’, on Friday.

The AIM-traded firm said the double blind, randomised, placebo-controlled phase 2 and 3 trial was to assess SFX-01 plus standard care in patients initially hospitalised with community-acquired pneumonia, including patients investigated for suspected Covid-19 infection.

It said the trial was 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, which was extended to incorporate the full 133 patients recruited to date.

Evgen said it 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 would now be halted as a result.

Evgen said there were no safety issues observed relating to active treatment, which the board said further underlined 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.

That would 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.

Those results would be reported in due course.

“We are surprised and disappointed by these findings given the strong preclinical hypothesis surrounding sulforaphane as an Nrf2 activator with potential direct antiviral properties,” said chief executive officer Dr Huw Jones.

“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.”

Dr Jones said 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 its positive phase 2 clinical data in metastatic breast cancer, Dr Jones noted that the firm had 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.”

At 1016 BST, shares in Evgen Pharma were down 32.75% at 5.01p.