Unigene Laboratories Inc.

Enteris Biopharma, Inc.

Keybioscience Ag

Ugp Therapeutics, Inc.

Keybioscience A/s

William Stern

Nozer M Mehta

James P Gilligan

Amy M Sturmer

Angelo P Consalvo

Kim Henriksen

Morten A Karsdal

John Vrettos

Stephen M Carl

Martha V L Ray

Martha V Ray

Morten Asser Karsdal

Martha VL Ray

Nozar M Mehta

Amy Sturmer

John Stanley Vrettos

Provided herein are methods for the treatment of type I diabetes, Type II diabetes, metabolic syndrome, or obesity, or of appetite suppression, or for mitigating insulin resistance, or for reducing an undesirably high fasting serum glucose level, or for reducing an undesirably high peak serum glucose level, or for reducing an undesirably high peak serum insulin level, or for reducing an undesirably large response to a glucose tolerance test in synergistic combination with metformin. A peptide selected from sequences SEQ ID NO: 12, SEQ ID NO: 15 and SEQ ID NO: 17 are administered.

Peptide analogs for treating diseases and disorders

Provided herein are peptides, that in combination with metformin, are effective for the treatment of type I diabetes, Type II diabetes, metabolic syndrome, or obesity, or of appetite suppression, or for mitigating insulin resistance, or for reducing an undesirably high fasting serum glucose level, or for reducing an undesirably high peak serum glucose level, or for reducing an undesirably high peak serum insulin level, or for reducing an undesirably large response to a glucose tolerance test in synergistic combination with metformin. The peptides are selected from sequences SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, and SEQ ID NO: 24.

The present invention provides peptides and pharmaceutical compositions thereof for appetite suppression and weight control. Preferred peptides are calcitonin analogs preferably with specific amino acid changes to make the peptide more amylin-like.

Methods of treating medical conditions using peptides

The present invention provides pharmaceutical compositions suitable for oral delivery and methods of treating subjects in need thereof. The pharmaceutical compositions of the present invention enhance bioavailability of at least one compound classified as BCS Class II, BCS Class III or BCS Class IV.

Pharmaceuticals for oral delivery

Provided herein are methods for the treatment of type I diabetes, Type II diabetes, metabolic syndrome, or obesity, or of appetite suppression, or for mitigating insulin resistance, or for reducing an undesirably high fasting serum glucose level, or for reducing an undesirably high peak serum glucose level, or for reducing an undesirably high peak serum insulin level, or for reducing an undesirably large response to a glucose tolerance test in synergistic combination with metformin. Treatment is effected with a combination therapy of metformin and a peptide with a sequence selected from SEQ ID NO: 11, SEQ ID NO: 12, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 15, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 19, SEQ ID NO: 20, SEQ ID NO: 21, SEQ ID NO: 22, SEQ ID NO: 23, and SEQ ID NO: 24 administered to a patient.

Bioavailability of peptide active agents to be administered orally is enhanced by a pharmaceutical composition providing targeted release of the peptide to the intestine by combining the composition with an absorption enhancer. Bioavailability is further significantly increased by administering the composition in an acid-resistant protective vehicle which transports components of the invention through the stomach. The composition may optionally further include a sufficient amount of a pH-lowering agent to lower local intestinal pH. All components are released together into the intestine with the peptide.

Oral delivery of peptide pharmaceutical compositions

The present invention provides solid oral dosage forms and methods of treating subjects in need thereof. The solid oral dosage forms of the present invention provide a mixture including at least one compound classified as BCS Class II, BCS Class III or BCS Class IV, where the compound does not include a peptide bond in the compound's molecular structure; an absorption enhancer; and coated organic acid particles; an enteric coating; and a water soluble barrier positioned between the mixture and the enteric coating.

Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.

Peptide pharmaceutical for oral delivery

The present invention provides peptides and pharmaceutical compositions thereof for appetite suppression and weight control. Preferred peptides are calcitonin analogs, preferably with specific amino acid changes to make the peptide more amylin-like.

A peptide having a sequence selected from SEQ ID NO:11, SEQ ID NO:12, SEQ ID NO:13, SEQ ID NO:14, SEQ ID NO:15, SEQ ID NO:16, SEQ ID NO:17 and SEQ ID NO:18. Said peptide used for the treatment of type I diabetes, Type II diabetes, metabolic syndrome, or obesity, or of apetite suppression, or for mitigating insulin resistance, or for reducing an undesirably high fasting serum glucose level, or for reducing an undesirably high peak serum glucose level, or for reducing an undesirably high peak serum insulin level, or for reducing an undesirably large response to a glucose tolerance test.

Growing community of inventors

Tenafly, NJ, United States of America

William Stern