nogutsnoglory
Moderator
- Joined
- Sep 23, 2009
- Messages
- 8,908
I never even heard of this drug but its the second phase 3 trial drug to fail in recent weeks and that's upsetting.
"Investigational CCR9 antagonist vercirnon did not meet the primary endpoint of a phase 3 clinical trial evaluating its use in patients with moderate-to-severe Crohn’s disease, according to a press release.
In the double-blind, international, multicenter SHIELD-1 trial, 608 patients with moderate-to-severe Crohn’s disease (CD) across 200 facilities were randomized to receive either placebo or 500 mg vercirnon once or twice daily for 12 weeks. All participants had not responded adequately to prior conventional therapy. The primary endpoint of the trial was clinical response, defined as a Crohn’s Disease Activity Index (CDAI) score decrease of 100 points or more after conclusion of therapy. A CDAI below 150 points after 12 weeks of treatment was a key secondary endpoint.
According to the release, serious adverse events and study withdrawal due to serious events occurred at similar rates across the groups, but a dose-dependent increase in the incidence of overall adverse events was observed. Further recruitment and dosing has been suspended pending further review of the initial results. The trial was the first of a planned four studies assessing the safety and efficacy of vercirnon in a total of over 2,500 patients with CD.
“The results from the SHIELD-1 study are clearly disappointing but we are committed to further explore the data to determine the way forward to help patients with this chronic debilitating gastrointestinal disease,” Paul-Peter Tak, MD, PhD, senior vice president of immuno-inflammation R&D for the company, said in the release."
http://www.healio.com/gastroenterol...mary-endpoint-in-phase-3-crohns-disease-trial
"Investigational CCR9 antagonist vercirnon did not meet the primary endpoint of a phase 3 clinical trial evaluating its use in patients with moderate-to-severe Crohn’s disease, according to a press release.
In the double-blind, international, multicenter SHIELD-1 trial, 608 patients with moderate-to-severe Crohn’s disease (CD) across 200 facilities were randomized to receive either placebo or 500 mg vercirnon once or twice daily for 12 weeks. All participants had not responded adequately to prior conventional therapy. The primary endpoint of the trial was clinical response, defined as a Crohn’s Disease Activity Index (CDAI) score decrease of 100 points or more after conclusion of therapy. A CDAI below 150 points after 12 weeks of treatment was a key secondary endpoint.
According to the release, serious adverse events and study withdrawal due to serious events occurred at similar rates across the groups, but a dose-dependent increase in the incidence of overall adverse events was observed. Further recruitment and dosing has been suspended pending further review of the initial results. The trial was the first of a planned four studies assessing the safety and efficacy of vercirnon in a total of over 2,500 patients with CD.
“The results from the SHIELD-1 study are clearly disappointing but we are committed to further explore the data to determine the way forward to help patients with this chronic debilitating gastrointestinal disease,” Paul-Peter Tak, MD, PhD, senior vice president of immuno-inflammation R&D for the company, said in the release."
http://www.healio.com/gastroenterol...mary-endpoint-in-phase-3-crohns-disease-trial
