IN-STEP Phase IIb study results - V3381 misses primary endpoint in neuropathic pain

IN-STEP Phase IIb study results - V3381 misses primary endpoint in neuropathic pain
24 March 2010

Vernalis plc (LSE: VER), a development stage pharmaceutical company with a broad pipeline of clinical and early stage programmes, today announces the top-line results from the IN-STEP Phase IIb study, evaluating further the safety and efficacy of V3381 (indantadol) in patients with neuropathic pain due to diabetes.

This study enrolled 271 subjects with neuropathic pain caused by underlying diabetes into 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.  Although there was a 25% reduction compared to baseline in pain scores in patients who received V3381, there was also a marked reduction in the placebo-treated subjects and consequently no significant difference between the two treatment groups.

Indantadol was generally well tolerated at all doses in this study. As expected, the most common adverse event was dizziness (placebo 4%, indantadol 26%).

While the full analysis of the primary and secondary data from the study is ongoing, Vernalis is unlikely to conduct further studies with V3381 in neuropathic pain due to diabetes.  However, the ongoing pilot trial for the product in chronic cough will be completed, and the data assessed in the normal way to decide whether it should be progressed to the next stage of development.

Vernalis has one marketed product on which it receives royalties and seven priority product candidates in development (three of which are partnered), including five programmes in clinical development and two in pre-clinical development. Vernalis also has a number of other competitive research programmes. Our technologies, capabilities and products are endorsed by collaborations with leading, global pharmaceutical companies including GSK, Biogen Idec, Novartis, Servier, Chiesi, Menarini, and Endo.

Ian Garland, CEO of Vernalis commented: "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. 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".