SFX-01 is a synthetic version of sulforaphane, a known neuroprotective and anti-cancer agent, which is stabilised in a novel patented complex using a proprietary manufacturing process.
The Phase II trial, SAS (SFX-01 after Subarachnoid Haemorrhage), is a randomised, double blind, placebo controlled study comparing oral SFX-01 with placebo. The trial will recruit 90 patients, 45 in each treatment arm with all patients receiving nimodipine, the current standard of care. Patients will be dosed within 48 hours of experiencing SAH and approval has also been obtained in this study to provide for emergency dosing prior to consent. The primary endpoints include safety, pharmacokinetics and efficacy.
Nimodipine has been generic for more than 20 years, during which time there have been no significant clinical advances in the treatment of SAH. Whilst SAH is relatively rare, the market potential for this devastating condition, with its high unmet clinical need, is significant. In October 2015, Credit Suisse (commissioned by a US peer) estimated potential peak sales of $1.7bn by 2032 for a Phase III development product based on the intraventricular delivery of a nimodipine-based formulation.
SFX-01 potentially represents a new class of drug in aneurysmal SAH with a mechanism of action that specifically targets the Nrf-2 pathway, which in turn reduces the oxidative stress and the toxicity caused by free haemoglobin from the haemorrhage. Sulforaphane, the active ingredient of SFX-01, has been shown to be neuroprotective in multiple models of cerebral damage, including SAH.
It is expected that the SAS trial will report out Q2 2018. Further details of the study are available at: https://clinicaltrials.gov/ct2/show/study/NCT02614742
The Chief Investigator is Mr Diederik Bulters, Consultant Neurosurgeon and Honorary Senior Clinical Lecturer, at the Wessex Neurological Centre in Southampton.
Dr Stephen Franklin, Evgen Pharma's CEO, commented: "SAH is a rare and devastating condition, with a high unmet clinical need. Mechanistically, SFX-01 targets the principal drivers of the delayed vasospasm and, unlike nimodipine, is not trying simply to treat the vasospasm per se; as such it may represent the first step-change improvement in therapy in over 20 years. The commencement of the trial is a key milestone for the Company and I would like to thank the Chief Investigator, Mr Diederik Bulters, for his dedication and support."