Pfizer has released top-line results from two major Phase III trials from the Oral treatment Psoriasis Trials (OPT) Programme, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), of tofacitinib, the first in a new class of medicines, to treat patients with plaque psoriasis.
The trials evaluated the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, for the treatment of moderate-to-severe plaque psoriasis.
Both the trials showed that tofacitinib, as a 5mg or a 10mg dose taken as a pill twice-daily, met the primary efficacy endpoints of statistically significant superiority over placebo at Week 16.
The company said that no new safety signals for tofacitinib were observed in these two trials.
Pfizer Global Innovative Pharmaceutical business global medicines development lead Steven Romano said 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," Romano said.
"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 trials from the OPT Programme, OPT Compare and OPT Retreatment, were previously reported in October 2013.
These four trials, in addition to a long-term extension trial, will form the planned psoriasis submission package to regulatory authorities in several markets.
The company currently intends to submit a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) by early 2015 for the approval of tofacitinib 5mg and 10mg twice-daily for treatment of adults with moderate-to-severe chronic plaque psoriasis.
The Phase III OPT clinical trial programme includes five studies evaluating oral tofacitinib 5mg and 10mg twice-daily in adults with moderate-to-severe chronic plaque psoriasis.