A clinical stage drug company developing sulforaphane-based medicines for cancer treatment has started recruiting for a pharmacokinetic / pharmacodynamic trial in healthy volunteers (HV).
Evgen Pharma plc also announced the start an investigator sponsored clinical study (ISS) for a glioblastoma program.
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 October 3, 2022, the study is now open for recruitment. The first subjects are expected to enter the trial on schedule this week.
The trial is a placebo-controlled, dose-escalating, randomized 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 says it has been consulting widely with 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 tumor and its interaction with molecular targets in the tumor 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 ISS, led by 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.
Rare disease with unmet needs
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 program is likely to be continued as an Evgen-sponsored trial.
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 last quarter of 2024. This runway will extend into 2025 if further milestones relating to the results from the HV study and U.S. Food and Drug Administration (FDA) IND approval are received following the Stalicla SA licensing transaction announced this week.
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 says it will look for partnering opportunities in parallel to the ISS. Evgen’s other programs, including in breast cancer, are also continuing as planned.
Promising pre-clinical data
Huw Jones, Evgen CEO, said: “We expect to have a very complete set of data regarding the performance of the new formulation of SFX-01 by the first half of 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.”
He added that given the complexity of this disease, and the time and cost that goes into such clinical studies, the company wants to de-risk the program as much as possible. Under advice from experts, Evgen says it believes a stronger understanding of the potential direct impacts of SFX-01 in the brain tumor tissue itself will enable the company to improve the trial design further and enhance the prospects of success.
Jones said: “In the meantime, we are also focusing on our new and significant partnership with Stalicla SA and are driving our breast cancer program 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.”