Pear Therapeutics and Ironwood Pharmaceutical Evaluating GI Digital Therapeutics

Pear Therapeutics (Pear) is expanding its app-based platform to conditions outside of the brain and mental health through a gastrointestinal disease-focused collaboration with Ironwood Pharmaceuticals. 

Pear Therapeutics (Pear) aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including severe psychiatric and neurological conditions.

Pear lead product, reSET®, for the treatment of Substance Use Disorder, was the first prescription digital therapeutic to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, received marketing authorization from the FDA in December 2018. 

Pear currently maintains FDA-approved digital therapeutics for substance abuse and opioid use disorders and recently submitted a third product for insomnia and depression to the agency for review.

Novartis division Sandoz recently announced that it is handing sole responsibility for the commercialization of the reSET and reSET-O prescription digital therapeutics back to Pear Therapeutics.

Novartis’ Sandoz division backed out of a co-promotion agreement to market Pear Therapeutics’ prescription digital therapeutics. The companies said Pear’s current commercial infrastructure is sufficient to handle sole marketing for the digital medicines, known as reSET and reSET-O. Sandoz attributed its decision to shifting organizational and leadership, which resulted in a reinforced focus on and capital allocation for Sandoz core business.

Pear recently announced the filing of a submission to the FDA seeking marketing authorization for Somryst™, a prescription digital therapeutic (PDT) intended for use in the treatment of adults with chronic insomnia and depression.  Somryst is intended to provide tailored neurobehavioral interventions, specifically Cognitive Behavioral Therapy for insomnia (CBTi) and sleep restriction driven by learning algorithms to reduce the severity of insomnia and symptoms of depression.

Ironwood’s gastrointestinal franchise, meanwhile, includes the FDA-approved Linzess in partnership with Allergan. The drug is currently indicated for irritable bowel syndrome (IBS) and chronic constipation, and it’s also being studied in other IBS-related abdominal symptoms and pediatric constipation.

The company is also pursuing a separate, mid-phase treatment for abdominal pain associated with IBS and diarrhea through its Allergan partnership, MD-7246—as well as IW-3718, an internal candidate for persistent gastroesophageal reflux disease.  

Takeaway: Ironwood Pharmaceuticals testing digital therapeutics opportunity to explore developing Prat Therapeutics’ innovative prescription digital therapeutics or PDTs for the treatment of selected indications within the GI space.