Commentary: larazotide acetate ‐ an exciting new development for coeliac patients? Authors’ reply

Kelly, Ciarán P.; Green, P. H.R.; Murray, Joseph A.; DiMarino, Anthony J.; Colatrella, Anthony M.; Leffler, Daniel A.; Alexander, T.; Arsenescu, Razvan; León, Francisco; Jiang, John; Arterburn, L. A.; Paterson, Blake M.; Fedorak, Richard N.

doi:10.1111/apt.12196

Cited by 3 publications

(2 citation statements)

References 2 publications

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“…Likewise, although a large number of patents have been filed for ZoT and its capacity to generate oral insulin delivery in rats [106], the more important output was the discovery of zonulin, an endogenous mediator of epithelial permeability involved in intrinsic control of barrier integrity [107]. An associated discovery was that of larazotide acetate (Alba Therapeutics, USA), an 8-mer peptide that promotes TJ assembly [108] and is currently in clinical development for management of coeliac disease [109,110].…”

Section: Paracellular Pes Emerging From the Study Of Toxinsmentioning

confidence: 99%

Intestinal permeation enhancers for oral peptide delivery

Maher

Mrsny

Brayden

2016

Advanced Drug Delivery Reviews

282

201

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Publication informationAdvanced Drug Delivery Reviews, (Part B): 277-319 Publisher ElsevierItem record/more information http://hdl.handle.net/10197/7800Publisher's statement þÿ T h i s i s t h e a u t h o r s v e r s i o n o f a w o r k t h a t w a s a c c e p t e d f o r p u b l i c a t i o n i n A d v a n c e d D r u g Delivery Reviews. Changes resulting from the publishing process, such as peer review,

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Section: Paracellular Pes Emerging From the Study Of Toxinsmentioning

confidence: 99%

Intestinal permeation enhancers for oral peptide delivery

Maher

Mrsny

Brayden

2016

Advanced Drug Delivery Reviews

282

201

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“…1 Two patients failed run-in; 2 one patient did not complete data collection; 3 one patient started placebo before washout. a 1-week recall period, from the original 4-week recall) and the CeD-GSRS (total score as well as scores in three domainsabdominal pain, indigestion, and diarrhea) (12).…”

Section: Methodsmentioning

confidence: 99%

Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial

Yoosuf

Barrett²,

Papamichael³

et al. 2023

Front. Med.

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BackgroundPancreatic Exocrine Insufficiency (PEI) is a possible cause of recurrent/persistent symptoms in celiac disease. Although pancreatic enzyme supplementation may be used to treat non-responsive celiac disease (NRCD) in clinical practice, clinical outcomes are variable and there is limited and low quality evidence to support this practice. The aim of this study was to assess the efficacy of pancreatic enzyme supplements (PES) for improvement of gastrointestinal symptoms in NRCD.MethodsProspective, randomized, placebo-controlled, double-blind, cross-over trial in adults with NRCD examining Celiac Disease-Gastrointestinal Symptom Rating Scale (CeD-GSRS) scores on PES (pancrelipase co-administered with omeprazole) versus placebo (omeprazole only) during a 10-day treatment period. The study was registered under the clinical trials registry (https://clinicaltrials.gov/ number, NCT02475369) on 18 Jun 2015.ResultsTwelve participants (nine female) were included in the per-protocol analysis; one participant had low fecal elastase-1. Pancrelipase was not associated with significant change in CeD-GSRS compared to placebo (−0.03 versus −0.26; P = 0.366). There was a significant decrease in mean values of total CeD-GSRS scores (3.58 versus 2.90, P = 0.004), abdominal pain (2.92 versus 2.42, P = 0.009), and diarrhea sub-scores (3.44 versus 2.92, P = 0.037) during the run-in period with omeprazole.ConclusionIn this prospective, cross-over randomized, placebo-controlled study, PES did not improve symptoms in patients with NRCD. It is unclear whether this is a trial effect or related to administration of omeprazole.

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Current status of drugs in development for celiac disease

Kurppa

Hietikko

Sulic

et al. 2014

Expert Opinion on Investigational Drugs

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It is anticipated that some of the treatments under investigation will soon enter Phase III clinical trials, although challenges remain. For instance, histological studies are problematic in wide-scale clinical studies. On the other hand, the existing non-invasive serological methods and clinical outcome measures might be too insensitive for monitoring responses to the possible drug candidates. There is also no animal model which would accurately reflect celiac disease. Well-conducted basic and clinical research is required to develop better non-invasive surrogate markers and patient-related outcomes for future pharmacological studies.

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Commentary: larazotide acetate ‐ an exciting new development for coeliac patients? Authors’ reply

Cited by 3 publications

References 2 publications

Intestinal permeation enhancers for oral peptide delivery

Intestinal permeation enhancers for oral peptide delivery

Pancreatic enzyme supplementation versus placebo for improvement of gastrointestinal symptoms in non-responsive celiac disease: A cross-over randomized controlled trial

Current status of drugs in development for celiac disease

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