Catalyst

Slingshot members are tracking this event:

Gilead Terminates Phase 2/3 Study of GS-5745 in Patients With Ulcerative Colitis

Do you think this event is important to the companies below? How will it affect their stock price?

Related Companies
Importance
High Medium Low
Impact on Stocks
GILD

100%

Additional Information

Additional Relevant Details Gilead is stopping its combined Phase 2/3 clinical study of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis. This decision follows a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC) after the first 150 patients of a planned 1600-patient trial were treated for an 8-week induction duration. The DMC recommended that the study be terminated early due to meeting the pre-specified futility and efficacy criteria. No safety concerns were noted in this interim analysis. Gilead has also reviewed the data and determined that there is insufficient evidence of a treatment benefit in the group of patients randomized to receive either one of two doses of GS-5745.Separately, a Phase 3 study of GS-5745 is ongoing in patients with gastric cancer, as well as a Phase 2 study in patients with gastric cancer in combination with nivolumab and additional Phase 2 studies in moderately to severely active Crohn’s disease, rheumatoid arthritis and cystic fibrosis. These studies will continue as planned.
http://www.gilead.co...
Slingshot Insights Explained
Catalyst Date
Occurred on:
Sep 21, 2016
Related Projects Image
  • Don’t see a project related to the catalyst you care about?

Related Keywords Gs-5745, Ulcerative Colitis, Anti-mmp9 Antibody