Health and Healthcare

Pfizer Posts Positive Late-Stage Results in Colitis Trials

Chris Lange

Published: March 18, 2016 12:40 pm

Last Updated: January 13, 2020 11:46 am

Pfizer Inc. (NYSE: PFE) made waves on Friday following the announcement of a late-stage clinical trial. The pharmaceutical giant announced the results from its first two pivotal Phase 3 studies from the Oral Clinical Trials for tofacitinib in ulcerative colitis (Octave) program at the 11th Congress of European Crohn’s and Colitis Organization (ECCO).

Both Octave Induction 1 and Octave Induction 2 met their primary endpoint. At Week 8, a significantly greater proportion of patients receiving tofacitinib 10 mg BID were in remission as compared to placebo. The results from Octave Induction 2 were consistent, with a significantly greater proportion of patients receiving tofacitinib 10 mg BID in remission as compared to placebo.

Additionally, a significantly greater number of patients receiving tofacitinib 10 mg BID achieved mucosal healing at Week 8 as compared to placebo, the key secondary endpoint in both studies. In Octave Induction 1, 31.3% of patients receiving tofacitinib 10 mg BID achieved mucosal healing as compared to 15.6% of patients treated with placebo. Similar results were seen in Octave Induction 2 with 28.4% of patients receiving tofacitinib 10 mg BID achieving mucosal healing as compared to 11.6% of patients treated with placebo.

Geert D’Haens, M.D., Ph.D., Professor of Gastroenterology at the Academic Medical Center, University of Amsterdam, and study investigator, commented:

Ulcerative colitis can be a difficult disease to manage, as many patients fail or become intolerant to conventional therapies. We are encouraged by the results from the OCTAVE Induction studies, as they showed that in these trials oral tofacitinib reduced the symptoms of moderate to severe ulcerative colitis and induced remission of the disease. What’s more, these results were seen in patients who were previously treated with tumor necrosis factor inhibitors (TNFis) as well as those who had not received treatment with TNFis. And, improvements in symptoms were observed as early as week 2, the first time point it was measured.

Shares of Pfizer were trading at $29.52 on Friday, with a consensus analyst price target of $38.81 and a 52-week trading range of $28.25 to $36.46.