Pfizer recently released the top-line results from two Phase III induction studies of twice-daily tofacitinib (10 mg tablets) for ulcerative colitis, within the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) global program. According to the report, both clinical trials were successful at meeting specified primary endpoints, as determined by the number of patients treated with the drug who have achieved remission after 8 weeks compared to those who were given a placebo.
“We are encouraged by the results of the OCTAVE induction studies as ulcerative colitis is a chronic, and at times debilitating, disease that can be difficult to treat” said the senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc, Rory O’Connor, MD in a press release. “Pfizer remains committed to advancing the science of Janus kinase inhibition and enhancing understanding of tofacitinib, the first in this new class of medications being investigated for ulcerative colitis. We look forward to sharing the results of our ongoing Phase 3 maintenance study OCTAVE Sustain, when available, which will provide further information on tofacitinib in ulcerative colitis.”
Pfizer also reported tofacitinib did not induce any untoward side effects, with recently-reported incidences holding similarities to those already noted in past studies with the drug. The findings from both OCTAVE Induction I and OCTAVE Induction II will be analyzed in detail to establish tofacitinib efficacy and safety in preparation for submission and presentation at an upcoming scientific conference.
Both induction studies were designed as similar Phase III placebo-controlled clinical trials, focused on determining tofacitinib 10 mg tablets’ ability to induce disease remission in patients diagnosed with moderate to severe ulcerative colitis. Induction I trial enrolled 598 patients, while Induction II enrolled 541, who were all then randomized to receive a twice-a-day dose of either the drug or a placebo.
The OCTAVE global clinical development program consists of three Phase III trials (OCTAVE Induction 1, Induction 2 and OCTAVE Sustain) and an additional long-term extension supporting study, OCTAVE Open. Findings from OCTAVE Sustain are expected before the end of 2016. Once all studies have been completed, Pfizer will prepare a submission package to regulatory authorities for the potential drug’s approval as an ulcerative colitis therapy.
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