Shire said today it has agreed to license from Pfizer worldwide rights to all indications for the Phase III–ready inflammatory bowel disease (IBD) candidate PF-00547659.
The licensing deal—whose value was not disclosed—“fits with Shire’s commitment to advancing research and development in select specialty areas, including areas of unmet patient need for gastrointestinal conditions such as IBD,” Howard Mayer, Shire’s head of clinical development, said in a statement.
Gastrointestinal/endocrine conditions represent one of the company’s four therapeutic areas of focus. The other three are hereditary angioedema (HAE), neuroscience, and lysosomal storage diseases.
PF-00547659 is a fully human monoclonal antibody being developed for the treatment of moderate-to-severe IBD. PF-00547659 is designed to work by targeting mucosal addressin cell adhesion molecule 1 (MAdCAM-1), a gastrointestinal endothelial adhesion molecule that binds to the α4β7 integrin on lymphocytes.
PF-00547659 has been evaluated in more than 700 patients in Phase I and II trials, with Phase III trials expected to begin following consultation with regulators, Shire said.
The candidate has completed Phase II clinical trials in ulcerative colitis (UC) and UC and Crohn’s disease (CD), known as TURANDOT and OPERA, respectively. The Phase II studies showed no evidence of increased infection, including in MAdCAM-expressing tissues (gastrointestinal tract, nasal tissue, spleen, bladder, uterus, and lung), and no progressive multifocal leukoencephalopathy.
The TURANDOT study met its primary and secondary end points. Adult patients with moderate-to-severe active UC who failed at least one previous treatment and were treated with PF-00547659 showed an increased rate of remission, response, and mucosal healing at week 12, compared to placebo, Shire said.
Additionally, long-term treatment with PF-00547659 has been evaluated in the completed OPERA II CD study and is ongoing in the TURANDOT II UC study.
Shire said its licensing agreement with Pfizer is subject to waiver of the Hart–Scott–Rodino Antitrust Improvements Act as amended.