Treating Chronic Disease Caused by Microbiome Dysbiosis

Science

ISOThrive is a clinical stage biotech company focused on treating chronic disease caused by microbiome dysbiosis.

 Initial Focus: GERD

 

ISOThrive’s first indication is Gastroesophageal Reflux Disease (GERD), a condition that affects 1/3 of the U.S. adult population and is one of the largest drug categories worldwide.

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Facts on GERD

Patients with GERD experience reduced quality of life, most strikingly on measures of pain, mental health, and social function (Revicki et al, 1998).

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30% of the US population suffers from Gastroesophageal Reflux Disease (GERD). 

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20-45 million people prescribed proton pump inhibitors (PPIs).

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46% of patients want to discontinue PPIs.

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39% have tried to do so without medical advice, increasing the risk of GI bleeding, Barrett’s esophagus and esophageal adenocarcinoma (Kurlander et al, 2019).

 
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PPIs don’t cure GERD

Potential adverse effects of diminished gastric acid production include C. difficile infection, pneumonia, anemia, osteoporosis and more.

As many as 40% of patients taking PPIs still have symptoms and require an alternative solution.

 
 

How ISOT-101 Works

ISOT-101 is a patented/patents-pending proprietary digestion-resistant carbohydrate, maltosyl-isomaltooligosaccharide (MIMO), which is an energy source (prebiotic) for targeted beneficial bacteria. It is a carbohydrate analog to typical small molecule drugs (i.e. highly targetable for a specific therapeutic effect).

GERD sufferers have a distinctly different gram-negative bacterial dysbiosis at the lower esophageal sphincter (LES), whereas healthy individuals have a predominantly gram-positive LES microbiome (Pei Z, 2005; Yang L, 2014; Baghdadi J, 2014). This dysbiosis triggers a type of cytokine-induced inflammation that weakens the LES, enabling chronic reflux.

ISOT-101 is designed to restore the normal localized microbiome at the Lower Esophageal Sphincter (LES) from an unusual gram-negative predominant state to a normal predominantly gram-positive healthy state, and thereby stop acid reflux at the root cause.  ISOT-101 is a safe (GRAS status) and effective alternative to daily PPIs.

Bacterial dysbiosis in the stomach (H. pylori) is now known to be the cause of gastric ulcers, and the concomitant inflammation to be the precursor to stomach cancer.  By treating the pro-inflammatory microbiome dysbiosis at the LES that is found in GERD as well as Barrett’s Esophagus and esophageal cancer, we have the potential to not only resolve GERD but also stop the progression of the disease.  PPIs do not provide such potential protection..

 

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