Vernalis' IN-STEP trial fails, chronic cough result due in 2011

UK-based Vernalis saw its share price plunge as much as 20% after the company reported top-line results of the 162-patient IN-STEP Phase IIb trial of indantandol in diabetic neuropathic pain (DNP) which indicated that a high placebo response rate caused the primary endpoint of change in pain score from baseline to be missed.

An earlier Phase IIa study in this indication gave mixed results due to high placebo responders which led Vernalis to design INSTEP with a two-week placebo run-in period in an attempt to eliminate this effect. Of the 271 patients enrolled in IN-STEP, 162 went on to enrol in the 13-week, double-blind, placebo-controlled treatment phase of placebo or up to 400mg indantadol taken twice a day.

While the full analysis of the IN-STEP dataset is ongoing, it is unlikely that Vernalis will carry out further studies of indantadol in DNP (historically a high-risk indication from a development perspective); the failure of this trial has also removed a potential near-term partnering catalyst, comment analyst Robin Davidson at Edison Equity Research.