Evgen Pharma plc, the clinical stage drug development company focused on the treatment of cancer and neurological conditions, yesterday announced that it had received the required approvals for the commencement of its Phase II trial of SFX-01 in aneurysmal subarachnoid haemorrhage (‘SAH’), a form of stroke. Patient recruitment and first dosing in the 90 patient trial is expected to start in early Q2 calendar year 2016 following the approval of the trial by the Medicines and Healthcare Products Regulatory Agency and by a research ethics committee. Evgen Pharma’s SFX-01 is a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, a known neuroprotective and anti-cancer agent. 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.
Beaufort Securities view: The commencement of Phase II trial of the novel compound SFX-01 in aneurysmal subarachnoid haemorrhage is an important step forward to Evgen. There is a very clear unmet medical need in this condition, for which there has been no significant clinical advances for more than 20 years. Significantly, SFX-01 has the possibility of qualifying for orphan drug status for SAH in most major regulatory jurisdictions, potentially giving it extended market exclusivity and making it easier and faster for the treatment to gain marketing approval. Beyond this, the Group’s other programmes in metastatic breast cancer and multiple sclerosis are proceeding as planned and the Group is expected to provide further updates on these in due course. Beaufort retains its Speculative Buy recommendation on the shares.
