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 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: Modified natriuretic compounds and conjugates thereof are disclosed in the present invention. In particular, conjugated forms of hBNP are provided that include at least one modifying moiety attached thereto. The modified natriuretic compound conjugates retain activity for stimulating cGMP production, binding to NPR-A receptor, and in some embodiments an improved half-life in circulation as compared to unmodified counterpart natriuretic compounds. Oral, parenteral, enteral, subcutaneous, pulmonary, and intravenous forms of the compounds and conjugates may be prepared as treatments and/or therapies for heart conditions particularly congestive heart failure. Modifying moieties comprising oligomeric structures having a variety of lengths and configurations are also disclosed. Analogs of the natriuretic compound are also disclosed, having an amino acid sequence that is other than the native sequence.

Abstract: Modified natriuretic compounds and conjugates thereof are disclosed in the present invention. In particular, conjugated forms of hBNP are provided that include at least one modifying moiety attached thereto. The modified natriuretic compound conjugates retain activity for stimulating cGMP production, binding to NPR-A receptor, and in some embodiments an improved half-life in circulation as compared to unmodified counterpart natriuretic compounds. Oral, parenteral, enteral, subcutaneous, pulmonary, and intravenous forms of the compounds and conjugates may be prepared as treatments and/or therapies for heart conditions particularly congestive heart failure. Modifying moieties comprising oligomeric structures having a variety of lengths and configurations are also disclosed. Analogs of the natriuretic compound are also disclosed, having an amino acid sequence that is other than the native sequence.

Abstract: Modified natriuretic compounds and conjugates thereof are disclosed in the present invention. In particular, conjugated forms of hBNP are provided that include at least one modifying moiety attached thereto. The modified natriuretic compound conjugates retain activity for stimulating cGMP production, binding to NPR-A receptor, and in some embodiments an improved half-life in circulation as compared to unmodified counterpart natriuretic compounds. Oral, parenteral, enteral, subcutaneous, pulmonary, and intravenous forms of the compounds and conjugates may be prepared as treatments and/or therapies for heart conditions particularly congestive heart failure. Modifying moieties comprising oligomeric structures having a variety of lengths and configurations are also disclosed. Analogs of the natriuretic compound are also disclosed, having an amino acid sequence that is other than the native sequence.

Abstract: Modified natriuretic compounds and conjugates thereof are disclosed in the present invention. In particular, conjugated forms of hBNP are provided that include at least one modifying moiety attached thereto. The modified natriuretic compound conjugates retain activity for stimulating cGMP production, binding to NPR-A receptor, and in some embodiments an improved half-life in circulation as compared to unmodified counterpart natriuretic compounds. Oral, parenteral, enteral, subcutaneous, pulmonary, and intravenous forms of the compounds and conjugates may be prepared as treatments and/or therapies for heart conditions particularly congestive heart failure. Modifying moieties comprising oligomeric structures having a variety of lengths and configurations are also disclosed. Analogs of the natriuretic compound are also disclosed, having an amino acid sequence that is other than the native sequence.

Abstract: Modified n atriuretic compounds and conjugates thereof are disclosed in the present invention. In particular, conjugated forms of hBNP are provided that include at least one modifying moiety attached thereto. The modified natriuretic compound conjugates retain activity for stimulating cGMP production, binding to NPR-A receptor, and in some embodiments an improved half-life in circulation as compared to unmodified counterpart natriuretic compounds. Oral, parenteral, subcutaneous, and intravenous forms of the compounds and conjugates may be prepared as treatments and/or therapies for heart conditions particularly congestive heart failure. Modifying moieties comprising oligomeric structures having a variety of lengths and configurations are also disclosed. Analogs of the n atriuretic compound are also disclosed, having an amino acid sequence that is other than the native sequence.

Abstract: Pharmaceutical compositions that include an insulin drug-oligomer conjugate, a fatty acid component, and a bile salt component are described. The insulin drug is covalently coupled to an oligomeric moiety. The fatty acid component and the bile salt component are present in a weight-to-weight ratio of between 1:5 and 5:1. Methods of treating an insulin deficiency in a subject in need of such treatment using such pharmaceutical compositions are also provided, as are methods of providing such pharmaceutical compositions.