Shire to License Global Rights for Pfizer Biologic
PF-00547659 is an investigational biologic being evaluated for the treatment of moderate-to-severe inflammatory bowel disease (IBD). The biologic is designed to directly target a gastrointestinal (GI) endothelial adhesion molecule known as mucosal addressin cell adhesion molecule 1 (MAdCAM-1), that binds to the α4β7 integrin on lymphocytes.
The biologic has completed Phase III clinical trials in (UC) and Crohn’s disease (CD), known as Turandot and Opera, respectively. Turandot met its primary and secondary end points; adult patients with moderate to severe active UC who failed at least one previous treatment who were treated with PF-00547659 showed an increased rate of remission, response, and mucosal healing at week 12, compared to placebo. The most commonly reported adverse events were consistent with the underlying disease.
The safety study TOSCA evaluated PF-00547659 in adult patients with moderate to severe CD with prior treatment with both anti-TNF and immunosuppressants (azathioprine, 6-MP or methotrexate). In patients who received a full induction course of the highest clinical dose of PF-00547659, there was no change in CSF lymphocyte cell count after treatment. Furthermore, in the completed Phase II clinical studies, there was 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 Phase III trials for the biologic are expected to begin after consultation with global health authorities.
Commenting on the news, Howard Mayer, Head of Clinical Development, Shire, said: “This licensing transaction 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. We look forward to continuing the development of PF-00547659, a unique and differentiated biologic that will benefit from our experience in IBD and across the gastrointestinal space.”
The terms of the deal between Pfizer and Shire were not disclosed.