New enteric-coated tablet formulation will now replace the previous prototype capsule
Evgen Pharma – a company focused on the development of sulforaphane-based medicines – has announced that it has completed the dosing of all three cohorts of its dose-escalating, placebo-controlled, randomised phase 1/1b clinical trial.
The research aims to provide insights into the pharmacodynamic and pharmacokinetic characteristics of the new enteric coated tablet formulation of the company’s lead asset SFX-01. It has also investigated how sulforaphane released from SFX-01 engages with molecular targets of interest.
All the cohorts comprise of eight healthy volunteers dosed with either SFX-01 or a placebo. The dosing has been completed on schedule and analysis of the data is continuing. Meanwhile, the trial is on track to report full data in the second quarter of 2023.
The new enteric-coated tablet formulation will now replace the previous prototype capsule formulation. The tablet releases sulforaphane to a targeted part of the intestine, with the joint goals of predicable release and minimisation of gastro-intestinal side effects. Furthermore, the new formulation – if it performs as expected – will be suitable for large scale trials and commercial supply.
SFX-01 is a patented composition of synthetic sulforaphane and alpha-cyclodextrin. Evgen has already completed three trials in patients, including a positive open label trial in metastatic breast cancer using the prototype capsule formulation.
Dr Huw Jones, Evgen’s chief executive officer, explained: “Our study has been proceeding exactly to plan, and data will be available in the second quarter of this year, as expected. We anticipate that it will confirm improved delivery of SFX-01 with our new formulation.”
He added: “In addition, it will demonstrate further how sulforaphane engages with key molecular targets as we expand into new indications in oncology and neurodevelopmental disorders.”
The company’s core technology is Sulforadex – a method for synthesising sulforaphane and novel proprietary analogues based on it.
Sulforaphanes have already demonstrated potential benefits in neurodevelopmental disorders, oncology and inflammatory conditions.
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