New formulation may be suitable for large-scale trials and commercial supply in the future
Evgen – a clinical stage company developing sulforaphane-based medicines for the treatment of cancer and other indications – has received regulatory approvals for a healthy volunteer study to examine the performance of SFX-01. The lead asset therapy is the company’s new enteric coated tablet formulation.
As well as safety, the study will investigate how sulforaphane released from SFX-01 engages with key molecular targets that are of interest to Evgen’s plans for clinical trials in cancer and a number of other indications.
Evgen developed the enteric-coated tablet formulation to replace previously used hand-filled capsules. The new coating is expected to release sulforaphane to a targeted part of the intestine, improving pharmacokinetic properties and minimising gastro-intestinal side effects.
The new formulation, if it performs as expected, will be suitable for large-scale trials and commercial supply. SFX-01 is the only stabilised sulforaphane suitable for clinical research and eventual approval as a medicine.
The phase 1/1b study will be a placebo-controlled, dose-escalating, randomised trial conducted in the UK. It is planned to start in the fourth quarter of 2022, with results expected in the first half of 2023.
SFX-01 is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. The company has already completed three trials involving patients, including a positive open label trial in metastatic breast cancer using a prototype capsule formulation.
Evgen’s core technology is Sulforadex – a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. Sulforaphanes have shown potential benefits in neurodevelopmental disorders, oncology and inflammatory conditions.
Dr Huw Jones, Evgen’s chief executive officer, reflected: “These approvals will enable us to launch our healthy volunteer study on schedule in the fourth quarter. This important study will provide deeper insights into our new formulation of SFX-01, its metabolism and the way it interacts with selected molecular targets, which will be key to informing future development work and trials.”