Abstract: The present invention provides Larazotide derivative compositions that resist protease degradation, and in various embodiments, do not demonstrate an inverse dose response, and/or can be delivered at higher doses without loss of potency or efficacy, thereby allowing improved therapy more desirable dosing schedules.

Abstract: The present invention provides compositions comprising an effective amount of a peptide having the amino acid sequence Gly-Gly-(d)Val-(d)Leu-(d)Val-(d)Gln-(d)Pro-Gly (SEQ ID NO: 6) to promote tight junction integrity, or a pharmaceutically acceptable salt thereof, and a pharmaceutically-acceptable carrier. The present invention further provides methods of using the larazotide derivative compositions for promoting tight junction integrity in patients in need thereof.

Abstract: The present invention provides Larazotide derivative compositions that resist protease degradation, and in various embodiments, do not demonstrate an inverse dose response, and/or can be delivered at higher doses without loss of potency or efficacy, thereby allowing improved therapy and more desirable dosing schedules.

Abstract: The present invention provides, in part, compositions comprising a peptide that is larazotide or larazotide derivative, or salt thereof, contained within a matrix that provides for controlled release and sustained release formulations. The present invention contemplates that these compositions, formulations and methods can be useful for treating diseases and disorders of the small bowel.

Abstract: The invention, in various aspects and embodiments, provides compositions and methods for treating or preventing inflammation of the lower gastrointestinal tract. The compositions and methods in various embodiments relate to rectal administration of pharmaceutical compositions that comprise an agent that forms one or more 4-AAPA compounds or 5-ASA compounds by azo reduction. In various embodiments, the compositions and methods treat, reduce, or prevent inflammation of the colon and/or rectum, as well as in some embodiments, an ileo-anal pouch in a subject. Compositions for rectal administration can be formulated as emulsions, suppositories (both suspension and solid), gels, and foam and foamable pharmaceutical compositions.

Abstract: The present invention provides compositions and methods for treating Sjogren's syndrome (SS), including primary or secondary SS, as well as methods for preventing clinical disease in patients at risk of developing clinical SS. In various embodiments, the invention relates to administering a regimen of larazotide (or derivative) and/or 4-APAA compounds or 5-ASA compounds (e.g., 5-ASA, 4-ASA, 4-Ac APAA, and 4-APAA) to a patient in need thereof.

Abstract: The present invention provides methods for treating disorders associated with intestinal barrier dysfunction and increased intestinal permeability. The invention involves administering an effective amount larazotide or a larazotide derivative to a subject or a patient in need thereof.

Abstract: The present invention provides methods and compositions for maintaining and improving the integrity of gastrointestinal epithelial tight junctions, thereby helping to maintain healthy paracellular permeability of the GI epithelium. The present invention provides methods and compositions for the treatment or prevention of various conditions that are associated with gastrointestinal paracellular permeability, including various autoimmune conditions, inflammatory liver diseases, as well as inflammatory conditions of the large or small intestines.

Abstract: The present invention provides Larazotide derivative compositions that resist protease degradation, and in various embodiments, do not demonstrate an inverse dose response, and/or can be delivered at higher doses without loss of potency or efficacy, thereby allowing improved therapy more desirable dosing schedules.