Pfizer’s JAK inhibitor meets endpoints in Phase III ulcerative colitis trials
pharmafile | March 21, 2016 | News story | Research and Development, Sales and Marketing | JAK inhibitor, Pfizer, ecco, endpoint, octave, tofacitinib, ulcerative colitis
Pfizer (NYSE:PFE) has announced that investigational JAK inhibitor – oral tofacitinib – met the primary and secondary endpoints in two pivotal Phase III ulcerative colitis clinical trials.
The company presented the results of the OCTAVE Induction 1 and OCTAVE Induction 2 clinical trials at the 11th congress of ECCO (European Crohn’s and Colitis Organisation).
The disease itself is a chronic condition of the inner lining of the rectum and colon, whose common symptoms include diarrhoea, cramping pains in the abdomen, tiredness and fatigue and anaemia.
Geert D’Haens, MD, PhD, Professor of Gastroenterology at University of Amsterdam, and study investigator, comments: “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 Indiction 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 tumour 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.”
Both clinical trials reached their primary endpoint. At week eight, a significantly greater proportion of patients receiving tofacitinib were in remission as compared to placebo in both trials. Additionally, a significantly greater number of patients receiving the drug achieved mucosal healing at week eight, compared to placebo, which was the key secondary endpoint. Similarly adverse events reported from those taking tofacitinib were broadly similar to those on placebo.
Results from OCTAVE Sustain, another Phase III trial in the program which evaluates the treatment as maintenance therapy in adult patients with moderately to severely active UC, are expected by the end of 2016.
Sean Murray
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