11th Nov 2019 12:23
(Alliance News) - Evgen Pharma PLC on Monday clarified that it is "unlikely" to pursue the subarachnoid haemorrhage opportunity as its "SFX-01 after subarachnoid haemorrhage" trial did not achieve the primary endpoint.
The stock sunk 54% in afternoon trade to 7.30 pence a share in London.
In the multi-centre, randomised, double-blind, placebo-controlled SAS phase II clinical trial, patients were dosed for a maximum of 28 days following a subarachnoid haemorrhage. Patients were then monitored for a further five months to assess their recovery by collecting endpoints including cognitive measurements.
The clinical stage drug development company said the trial did not show any "significant" difference between the SFX-01 and placebo arms.
"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," said Chief Executive Steve Franklin.
Furthermore, whilst the secondary endpoints were not statistically powered, there were no differences seen between SFX-01 and placebo in key cognition, quality of life and clinical outcomes at three and six months.
More positively, Evgen said SFX-01 was shown to be well-tolerated with no safety concerns.
Looking ahead, Evgen said it remains well funded and will concentrate its efforts on future partnering whilst developing product formulation for use in STEM II for the treatment of metastatic breast cancer and other investigator-led clinical studies.
The company also confirmed that it intends to pursue commercial opportunities for SFX-01 in oncology and other disease areas.
"Having achieved our primary endpoints in the metastatic breast cancer phase II trial, and considering our support for investigator-led clinical studies in alternative disease areas, we will continue to pursue attractive commercial opportunities for SFX-01," added Franklin.
By Evelina Grecenko; [email protected]
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