EVG.L Regulatory News (EVG)

Evgen Pharma plc

("Evgen" or the "Company")

Clinical Trial Update on healthy volunteer study of oral tablet formulation and glioblastoma programme including scientific advice

Healthy volunteer study open for recruitment

Alderley Park, UK - 12 October 2022: Evgen Pharma plc (AIM: EVG), a clinical stage drug development company developing sulforaphane-based medicines for the treatment of cancer and other indications, announces the start of recruitment for the pharmacokinetic/pharmacodynamic trial in healthy volunteers (HV) and the decision to commence an Investigator Sponsored clinical study (ISS) for the glioblastoma programme.

The purpose of the HV study is to examine the performance of Evgen's new enteric coated tablet formulation of lead asset SFX-01. Following the regulatory approval announced on 3 October 2022, the study is now open for recruitment and the first subjects are expected to enter the trial on schedule this week. The trial is a placebo-controlled, dose-escalating, randomised trial that will assess how SFX-01 in its new form and formulation is absorbed and circulates in the body, and how it engages with target molecules. Results of the HV study are expected during the first half of 2023.

In glioblastoma (GBM), Evgen has been consulting widely with world-renowned experts in the treatment of brain cancers with regards to the planned study. These key opinion leaders have advised that further pre-clinical work and an early-stage clinical trial of SFX-01 in patients with GBM should be conducted, to acquire more clarity on sulforaphane entering the brain tumour and its interaction with molecular targets in the tumour tissue of GBM patients. The Company expects that this approach will further de-risk the Phase 2 clinical trial.

This preliminary clinical work will be conducted as an Investigator Sponsored Study, led by Dr Marjolein Geurts, neuro-oncologist at the Erasmus University Medical Centre, the Netherlands. The Erasmus group has extensive experience in glioblastoma research, with several studies and numerous publications in this field. Evgen has already received positive and supportive regulatory scientific advice from the Dutch Medicines Evaluation Board (MEB), which also states that there are no specific concerns related to the clinical safety profile of SFX-01 based on available data. If the pre-clinical and ISS clinical work is successful, the trial programme is likely to be continued as an Evgen-sponsored trial. Evgen will update on the timing of this trial in due course.

Supporting an ISS in GBM for the first clinical phase will result in the Company having financial resources for a further year; at least to the end of Q4 2024. This runway will extend well into 2025 if further milestones relating to the results from the HV study and FDA IND approval are received following the Stalicla SA licensing transaction announced this week. Previous guidance issued was for a much shorter financial runway to Q4 2023.

Glioblastoma and malignant glioma as indications remain areas of high priority for Evgen, with encouraging pre-clinical data and an FDA Orphan Drug Designation awarded. Given the status of glioblastoma as a rare disease with significant unmet clinical need, the Company will look for partnering opportunities in parallel to the ISS. Evgen's other programmes, including in breast cancer, are also continuing as planned.

Dr Huw Jones, Evgen CEO, commented:

"We expect to have a very complete set of data regarding the performance of the new formulation of SFX-01 by H1 2023, as planned. This will generate more insight than ever into the way SFX-01 is handled in the bloodstream and how it interacts with the key molecular targets of interest in a wide range of diseases.

"We already have promising pre-clinical data in glioblastoma as well as Orphan Disease status which we announced last year. Given the complexity of this disease, and the time and cost that goes into such clinical studies, we want to de-risk the programme as much as possible. Under advice from experts, we believe a stronger understanding of the potential direct impacts of SFX-01 in the brain tumour tissue itself will enable us to improve the trial design further and enhance the prospects of success.

"In the meantime, we are also focussing on our new and significant partnership with Stalicla SA and are driving our breast cancer programme forward in collaboration with the Manchester Breast Centre. We continue to explore partnering opportunities in the context of a considerably longer cash runway, with the prospect of significant further non-dilutive cash inflows from our partners."

-Ends-

Enquiries:

Notes to Editors

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 Company's lead asset, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin and has undergone clinical trials for oestrogen-positive (ER+) metastatic breast cancer. In September 2021 the FDA granted Orphan Drug status to SFX-01 in malignant glioma.

The Company also has a wide number of collaborations with leading academic centres in the UK, Europe and AsiaPac as part of the continuing strategy to build the data set of safety and efficacy around the compound. With respect to non-core area, Evgen signed an out-licensing deal with JuvLife, the dietary products and functional foods division of Juvenescence Ltd, for the development of a naturally-sourced sulforaphane nutritional health supplement, stabilised using Evgen's Sulforadex® technology. Evgen also has a licensing deal with Stalicla SA in neurodevelopmental disorders and schizophrenia.

The Company has its headquarters and registered office at Alderley Park, Cheshire. 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