Evgen Pharma plc (AIM: EVG), the clinical stage drug development company developing sulforaphane based medicines for the treatment of cancers and inflammation, announces that it has progressed discussions with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) in relation to two clinical trials set to commence in 2022.
The first trial is a Phase I human volunteer study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of Evgen’s new SFX-01 tablet formulation. In addition, the study, which will recruit volunteers randomised to active and placebo arms, will generate data on dose escalation and target pathway engagement. Evgen held a scientific advice meeting with the MHRA in December 2021 at which the draft trial protocol was discussed and the MHRA’s written advice, which will reflect the discussions on the data to be submitted in support of approval of the trial, is expected in late January.
Separately, and also in accordance with time lines set out in Q1 2021, Evgen submitted an application for a pre-IND (Investigational New Drug application) meeting to the FDA in December 2021. This request has now been granted, to be effected by written responses to a meeting package that will be submitted to FDA in January. The IND will relate to a Phase Ib/II trial of SFX-01 in glioblastoma that is planned to commence in 2022 and Evgen is liaising with potential trial sites in the UK and Europe. The trial design will be adaptive to enable extension towards a registration if the data are supportive of this. In these circumstances trial sites in the US are likely to be involved.
Part of the proceeds from the 2021 placing and open offer have been applied to improve the synthesis and formulation of SFX-01 for commercial scale. This new tablet formulation will be used in all clinical trials; the production process has started and Evgen anticipates drug product will be available for commencement of the Phase I human volunteer study in Q2 this year.
Dr Huw Jones, Chief Executive Officer of Evgen Pharma, said: “I am delighted with the positive progress that has been made with MHRA and FDA regarding our two planned clinical trials for SFX-01, both of which we intend to commence later this year. We look forward to updating the market in due course regarding further progress with these key regulatory authorities and with regard to these two important trials.”
Evgen Pharma plc
Dr Huw Jones, CEO
Richard Moulson, CFO
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. SFX-01 has demonstrated efficacy in a Phase II trial for advanced metastatic breast cancer. It has been used to treat over 200 patients in clinical trials and is well-tolerated with predominately mild side-effects.
The Company has its headquarters at Alderley Park, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It is listed on the AIM market of the London Stock Exchange and trades under the ticker symbol EVG.
For further information, please visit: www.evgen.com
For research on the Company, please visit: http://evgen.com/investors/analyst-coverage/
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