Vernalis diabetes pain drug fails in phase II
pharmafile | March 24, 2010 | News story | Research and Development | Vernalis
Vernalis’ new treatment for neuropathic pain has disappointed in phase II trials and will now be dropped for this indication.
The UK biotech company announced the move with the release of top-line results from the IN-STEP phase IIb study of V3381 (indantadol) in patients with neuropathic pain caused by diabetes.
A total of 271 subjects with neuropathic pain caused by underlying diabetes took part in a 2-week placebo run-in period. Following this, 162 subjects were enrolled into a 13-week, double blind, placebo controlled treatment phase in which they were randomised to receive placebo or up to 400mg of indantadol twice a day.
The drug produced a 25% reduction compared to baseline in pain scores in patients who received V3381, but patients taking the placebo also saw a marked reduction, and consequently there was no significant difference between the two treatment groups.
Vernalis says it is ‘unlikely’ to conduct further trials of V3381 for these patients, but it will continue with an ongoing pilot trial to treat chronic cough.
The company has one marketed product on which it receives royalties – migrane treatment frovatriptan, marketed by Menarini in the UK as Migard and by Endo in the US as Frova.
Vernalis also has seven priority product candidates in development (three of which are partnered), including five programmes in clinical development and two in pre-clinical development.
The company’s chief executive Ian Garland acknowledged the trial results were a setback, but said the business was nevertheless on a sound footing.
“We have consistently stated the highly risky nature of diabetic neuropathy studies but nevertheless are disappointed with the results of the IN-STEP study in this difficult to treat indication,” said Ian Garland.
“However, Vernalis has a broad portfolio of products in clinical trials addressing substantial market opportunities.
“This, combined with the royalties from increasing sales of frovatriptan and significant existing cash resources that fund us for at least three years at current research and development investment levels, continues to give Vernalis strong potential for growth and value generation.”
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