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The therapy allows the treatment of neurological and oncological diseases
Eugen – the company developing the sulforaphane-based treatment – found that it dosed the first group of healthy volunteers in a placebo-controlled, dose-escalating phase 1/1b clinical trial of SFX-01. The therapy is a patented combination of synthetic sulforaphane and alpha-cyclodextrin.
The studies intend to provide further insights into the pharmacodynamic and pharmacokinetic characteristics of the new enteric-coated tablet formulation SFX-01. It also investigates how sulforaphane, released from the candidate, engages in key molecular targets.
The new formulation, which will replace prototype hand-filled capsules, delivers sulforaphane to a targeted part of the gut, with the goals of predictable elimination and reduced gastrointestinal side effects. If it performs as expected, the SFX-01 will be suitable for large-scale trials and commercial deployment.
Eugene’s Chief Executive Officer, Dr. Huw Jones, commented: “This first dosing is an important step in our schedule to develop SFX-01. We believe this confirms the improved delivery of SFX-01 through our new formulation.
“In addition, we will learn more about how the asset relates to key molecular targets as Eugen expands to new indications in oncology and neurodevelopmental disorders,” he added.
Eugene has already completed three SFX-01 trials in patients, including an open-label trial for metastatic breast cancer using the prototype capsule formulation. The company’s core technology, Sulforadex, is a method of stabilizing and synthesizing naturally occurring sulforaphane, in addition to new proprietary sulforaphane-based analogs.
Sulforaphanes have shown potential benefits in neurodevelopmental disorders, oncology, and inflammatory conditions. Meanwhile, SFX-01 is the only stabilized sulforaphane suitable for clinical research and eventual approval as a treatment.
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