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UK biotech Evgen craters on failed stroke trial

Shares in the biotech more than halved following the news

Brain

Evgen Pharma says it is ‘unlikely’ to continue development of its lead drug in haemorrhagic stroke after it failed a phase 2 trial.

News of the disappointing results in the SAS trial of SFX-01 caused shares in the biotech to more than halve, as investors fretted that the result could read through to Evgen’s other programmes, which are pretty much entirely based on the drug candidate.

Evgen subsequently put out a second statement to clarify that it remains ‘well-funded to pursue commercial opportunities for SFX-01 in oncology and other disease areas’.

SFX-01 is a composition of synthetic sulforaphane and alpha-cyclodextrin and is also being tested in a phase 2 trial in oestrogen-positive (ER+) metastatic breast cancer, as well as preclinical testing in models of multiple sclerosis.

Sulforaphane is usually a highly unstable oily liquid, but Evgen has developed a stable, solid form that can be used as an active pharmaceutical ingredient.

It is thought to activate the transcription factor Nrf2, stimulating the production of proteins with ‘antioxidative, anti-inflammatory and cytoprotective qualities’, according to the company.

The SAS trial tested the drug in subarachnoid haemorrhage – a type of stroke that involves bleeding into the space surrounding the brain – with patients dosed with SFX-01 for a maximum of 28 days after symptoms started, and followed up for a further five months.

Disappointingly, the main objective in SAS of reducing blood flow velocity in the middle cerebral artery was not achieved, with no significant difference between the SFX-01 and placebo arms, said the Liverpool-based biotech in a statement.

There was also no benefit with the drug on cognition, quality of life and other clinical outcomes, although Evgen notes the study wasn’t statistically powered to show an impact on these measures.

“We are surprised and disappointed by these findings given the strong preclinical data for sulforaphane in animal models of SAH and other forms of stroke,” commented the biotech’s chief executive Steve Franklin.

The demise of the drug in stroke means Evgen is now focused on its STEM breast cancer study of SFX-01, which generated encouraging preliminary results earlier this year.

STEM investigated whether SFX-01 could reverse acquired resistance to hormonal therapies for breast cancer such as tamoxifen, fulvestrant and third-generation aromatase inhibitors such as anastrozole and letrozole.

The open-label study suggested giving SFX-01 alongside these drugs improved anti-tumour activity and prolonged disease stabilisation in a population of heavily pre-treated patients whose cancer was getting worse despite hormonal drugs at the start of the study.

“We will review our company strategy relating to SFX-01's therapeutic applications, and further announcements will be made in due course,” said Franklin.

Article by
Phil Taylor

12th November 2019

From: Research

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