Minster Pharma’s phase IIb trial of novel migraine drug fails; will examine other applications
Minster Pharmaceuticals plc, the drug development company specialising in neurological and psychiatric disorders, said the Phase IIb study of tonabersat in migraine prevention did not meet its primary endpoint of reducing the number of migraine attacks suffered by patients.
The study confirmed the compound's positive safety profile, supporting the potential of the compound in other indications such as neuropathic pain and epilepsy.
The 500-patient Tonabersat Evaluation in Migraine Prevention in the US (TEMPUS) study involved patients receiving either tonabersat or placebo on a once-daily basis. The primary endpoint of the study was the reduction in the number of migraine attacks that patients suffered during the last eight weeks of a 20 week treatment period. Data from the secondary endpoints of the trial have yet to be collated, the company said
CEO Paul Sharpe said the results were "disappointing and surprising given the encouraging results of earlier studies.
"We need to conduct a detailed analysis of the TEMPUS results and to consider the potential of tonabersat in other indications before updating shareholders on our strategy for the compound."
The Cambridge-based company's share price shed almost 63% in morning trading to 9.13p. Its market capitalisation is now £5.37m
The company said that recently published research on the compound's novel mode of action, and its ability to modulate cellular communication via the gap junctions between nerve cells and glial cells, has provided the basis for a clearer insight into the most appropriate indications to pursue.
Tonabersat has previously produced positive results in a Phase II trial in migraine with aura and initial research suggests the compound could be clinically effective in epilepsy and has potential in neuropathic pain.
Minster said it has current net cash of £7.1m and a low cost base.
