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BTG plc commences first clinical study of novel migraine treatment

01 Feb 2008 - BTG plc announced that BGC20-1531, a potential treatment for migraine headaches, has commenced clinical development. Dosing has begun in a randomised, double-blind, placebo controlled phase I study, which will assess the safety, tolerability and pharmacokinetic profile of single rising doses of oral BGC20-1531 in healthy volunteers. The trial also incorporates a number of pharmacodynamic endpoints which may help to predict the efficacious dose range for future phase II studies in patients.
 
BTG licensed BGC20-1531 from Asterand plc (formerly Pharmagene plc) under an exclusive agreement in 2006. On reaching this clinical milestone, BTG has paid Asterand £250,000 as per the terms of the agreement.
 
Prostaglandin PGE2-induced cerebral vascular dilatation is thought to underlie migraine pain, particularly via activation of the EP4 receptor subtype. BGC20-1531 is an EP4 receptor antagonist that has been shown to competitively antagonise PGE2-induced vasodilatation of human middle cerebral and meningeal arteries in vitro, supporting its potential use as a treatment for migraine and other pain conditions. Furthermore, since EP4 receptors are discretely localised, the overall safety profile of EP4 receptor antagonists may be improved compared to triptans and NSAIDs.