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Partnership to Assess Digital Gut Disease Treatments

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(Michael Schwarzenberger, Pixabay)

31 Oct. 2019. A digital therapeutics enterprise and a company developing therapies for intestinal disorders are evaluating the potential of digital treatments for gut diseases. Financial and intellectual property details of the agreement between Pear Therapeutics Inc. and Ironwood Pharmaceuticals Inc., both in Boston, were not disclosed.

Pear Therapeutics develops what it calls prescription digital therapeutics that harness capabilities of electronic technologies to treat disease. The company says that even in digital form, its therapies are designed to treat serious disorders, evaluated with human clinical trials, subject to FDA review, and require a prescription. As reported by Science & Enterprise in December 2018, a mobile app made by Pear Therapeutics was the first such software cleared by FDA for opioid use disorder. A reSET app was earlier cleared by FDA to help treat other forms of substance abuse.

The app, known as reSET-O, contains a 12-week program of cognitive behavioral therapy, a form of psychotherapy that seeks to change attitudes and behavior by concentrating on a person’s cognitive processes — thoughts, images, and beliefs — related to that individual’s behavior. Users of the app receive incentives and rewards for sticking with their therapy, also known as contingency management, while clinicians can track clients’ progress with a dashboard in a desktop software program.

Most of Pear’s pipeline aims to treat disorders of the central nervous system, including insomnia, depression, schizophrenia, epilepsy, post-traumatic stress disorder or PTSD, and pain, as well as substance abuse. Through this partnership, the company aims to expand the scope of prescription digital therapeutics to other diseases. “This represents an important step for Pear,” says CEO Corey McCann in a company statement, “and broadens our pipeline to diseases outside the central nervous system and into a range of chronic conditions.”

Ironwood Pharmaceuticals develops treatments for gastrointestinal diseases. The company’s lead product is linaclotide, a synthetic peptide, marketed as Linzess by drug maker Allergan. Linaclotide targets guanylate cyclase-C receptor enzymes lining the intestinal tract, and are associated with a number of physiological functions and disorders in the gut. The drug is approved by FDA for adults with irritable bowel syndrome with constipation and chronic idiopathic constipation. Linaclotide is also being tested in clinical trials for constipation in children.

Irowood has two other experimental therapies in clinical trials, code-named IW-3718 for persistent gastroesophageal reflux disease or GERD, and MD-7246 for treating abdominal pain associated with irritable bowel syndrome with diarrhea. MD-7246 is also licensed to Allergan for development.

The agreement calls for Pear and Ironwood to evaluate prescription digital therapeutics for selected gastrointestinal disorders, although the specific conditions were not disclosed. The collaboration aims to combine Pear’s expertise in electronic therapies with Ironwood’s experience in clinical development and gastrointestinal diseases.

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