Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Valentis has halted development of its lead drug candidate, VLTS 934 for peripheral arterial disease, after it failed to meet expectations in a phase IIb clinical trial.
Subscribe to our email newsletter
No statistically significant difference was seen in the primary endpoint or any of the secondary endpoints in the phase IIb clinical trial. The company said that it may have to sell the business in the wake of the disappointing trial results.
The trial was a randomized, placebo-controlled trial of VLTS 934 versus a saline placebo in 157 patients with the intermittent claudication form of peripheral arterial disease (PAD).
After 90 days, there was no statistically significant change in exercise in the 78 patients receiving VLTS 934 versus the 79 patients receiving placebo. There were also no significant differences in any of the secondary endpoints of exercise tolerance at 30 days, ankle-brachial index at 30 and 90 days, total work capacity at 30 and 90 days and quality of life at 90 days.
“Based on the promising results in the phase IIa clinical trial, which utilized a virtually identical protocol, and our preclinical data indicating a viable mechanism of action, we expected the phase IIb trial to be positive. In our analysis of the available data including sub-groups, we could find no logical explanation for the difference in performance of the drug group between the two trials,” stated Benjamin McGraw, III, chairman, president & CEO of Valentis.