Pfizer reports positive data from new ulcerative colitis drug trials

Pfizer has announced that its drug tofacitinib has shown its effectiveness in the treatment of ulcerative colitis in a pair of clinical trials.

The company has reported top-line results from two phase III induction trials of tofacitinib 10 mg twice-daily tablets in the OCTAVE global clinical development programme, assessing the drug's efficacy among adults with moderate to severe ulcerative colitis.

Both the OCTAVE Induction 1 and OCTAVE Induction 2 studies met their primary efficacy endpoints, as measured by the proportion of patients receiving tofacitinib in remission after eight weeks compared to patients receiving placebo.

Rory O'Connor, managing director, senior vice-president and head of global medical affairs at Pfizer's global innovative pharmaceuticals business, said: "We look forward to sharing the results of our ongoing phase III maintenance study OCTAVE Sustain, when available, which will provide further information on tofacitinib in ulcerative colitis."

Results for OCTAVE Sustain are anticipated by the end of 2016, while a long-term extension trial, OCTAVE Open, is also part of the overall OCTAVE clinical development programme.

These four studies will form the potential submission package to regulatory authorities for approval of tofacitinib in a potential ulcerative colitis indication.