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BioPortfolio | BioPolaris | Diabetes R and D Pipeline: GLP-1 Agonists and Analogs

Diabetes R and D Pipeline: GLP-1 Agonists and Analogs

GLP-1 agonist and analogs are insulin secretagouge compounds. GLP-1 (glucagon-like peptide 1) is a potent glucoregulatory incretin hormone that lowers blood glucose levels postprandially. It is produced by intestinal L cells and released into circulation in response to ingestion of food, as well as neural and endocrine stimuli. Following its release into blood by intestine, in response to food intake, GLP-1 impacts several organs including intestinal tract where it slows food absorption.

This delay in food absorption allows acceleration of insulin response, which is otherwise slowed in patients with diabetes.

GLP-1 modifies glucose homeostasis by increasing biosynthesis and secretion of insulin, and by suppressing glucagon secretion. GLP-1 may also enhance insulin-independent glucose disposal in peripheral tissues. Preclinical models of diabetes showed that GLP-1 increases pancreatic beta-cell mass through mechanisms that includes stimulation of beta-cell proliferation and neogenesis, in addition to inhibition of beta-cell apoptosis. However, action of GLP-1 is short due to its rapid degradation.

The short biological half-life of GLP-1 after cleavage by DPP-4 (dipeptidyl peptidase-4) to GLP-1(9-36) amide is a major therapeutic drawback. There remains considerable interest in developing GLP-1-based compounds that can be administered less frequently than the current twice-daily injections and several GLP-1 analogs and agonists were developed with improved stability and insulinotropic action.

Compared with healthy people, pancreatic beta cells from patients with type 2 diabetes exhibit impaired responsiveness to GLP-1. It is known that sustained hyperglycemia have deleterious effects on beta cells. Clinical trials involving patients with poorly controlled type 2 diabetes, conducted to determine whether normalizing blood glucose levels could improve beta cell responsiveness to glucose and GLP-1, showed that, although GLP-1 can restore beta cell responsiveness to glucose, one month of insulin therapy, that resulted in near normalization of blood glucose levels, did not improve beta cell sensitivity to glucose or GLP-1.

The first GLP-1 agonist approved by the US Food and Drug Administration (FDA) was Byetta®, approved in May 2005.

Pipeline of Novel R & D GLP-1 Agonists and Analogs for the Treatment of Diabetes (BioPolaris)

The newly published Pipeline of Novel R & D GLP-1 Agonists and Analogs for the Treatment of Diabetes (BioPolaris) lists total of 27 investigational products of which 1 is is approved in EU and has NDA filed with the US Food and Drug Administration (FDA), for 1 NDA was filed recently, 4 are in Phase III clinical trials, 4 are in Phase II clinical trials, 4 are in Phase I clinical trials and 13 are in preclinical stage of development.

Total of 23 R & D GLP1 agonists and analogs are potential co-development or in-licensing products.

Analysis of mechanism of action shows 15 GLP-1 agonists, 9 GLP-1 analogs, 2 positive GLP-1 allosteric modulators and 1 GLP-1 peptide.

Total of 30 companies are developing new GLP1 agonists and analogs for diabetes, of which 5 are from Asia.

BioPolaris' report features detailed profile of each listed R & D product, showing product's indications, state and stage of development, designation status, delivery mode, characteristics, mechanism of action, monotherapy or combination therapy, efficacy and safety data (if available), origin, development company and co-development and in-licensing data.

Published: August 2009

Pages: 29
Price: $500.00 / €331.15

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