Pfizer announces positive top-line results from two Phase 3 trials of Tofacitinib in adults with moderate-to-severe chronic plaque psoriasis

Pfizer Inc. (NYSE:PFE) announced today top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis. The OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib, as a 5 mg or a 10 mg dose taken as a pill twice-daily, met the primary efficacy endpoints of statistically significant superiority over placebo at Week 16 in the proportion of subjects achieving a Physician’s Global Assessment response of “clear” or “almost clear,” and the proportion of subjects achieving at least a 75% reduction in Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.

No new safety signals for tofacitinib were observed in the OPT Pivotal #1 or OPT Pivotal #2 studies. Detailed analyses of these studies, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting.

“Psoriasis is a long-term disease with no cure that can have a significant impact on patients. Although it is one of the most common chronic inflammatory diseases, many psoriasis patients remain untreated, undertreated or dissatisfied with their treatment, according to recently published surveys,” said Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business. “Tofacitinib is the first in a new class of investigational psoriasis treatments, and I am encouraged by our Phase 3 results to-date that demonstrate the potential of tofacitinib to be an important new treatment option for adults with moderate-to-severe chronic plaque psoriasis.”

Top-line results from the first two studies from the OPT Program, OPT Compare and OPT Retreatment, were previously announced in October 2013, and these four studies, in addition to a long-term extension study, will form the planned psoriasis submission package to regulatory authorities in various markets. Pfizer currently intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the approval of tofacitinib 5 mg and 10 mg twice-daily for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015.

About OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079)

OPT Pivotal #1 and OPT Pivotal #2 were Phase 3, 52-week, multi-site, randomized, double-blind, placebo-controlled, parallel-group studies evaluating the safety and efficacy of tofacitinib 5 mg and 10 mg twice-daily in patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. There were over 900 patients randomized into each of the studies.

About the OPT Clinical Trial Program

The Phase 3 OPT clinical trial program consists of five studies (including one long-term extension study) evaluating oral tofacitinib 5 mg and 10 mg twice-daily in adults with moderate-to-severe chronic plaque psoriasis. It is a global, comprehensive clinical development program that includes over 3,600 patients in 36 countries, and is one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. In addition to the OPT Pivotal #1 and OPT Pivotal #2 studies, the OPT Program includes the following Phase 3 studies of tofacitinib in adults with moderate-to-severe chronic plaque psoriasis:

• OPT Compare (A3921080): A 12-week, Phase 3 study comparing the efficacy and safety of tofacitinib 5 mg and 10 mg twice-daily to high-dose ENBREL (etanercept) 50 mg twice-weekly as well as to placebo.
• OPT Retreatment (A3921111): A Phase 3 study evaluating the efficacy and safety of the withdrawal from, and then the retreatment with, tofacitinib 5 mg and 10 mg twice-daily compared to placebo.
• OPT Extend (A3921061): A long-term extension study evaluating the safety and tolerability of tofacitinib. Patients who participated in the Phase 2 trial or any of the other Phase 3 studies had the option, if eligible, to enroll in this study.