One step forward, two steps back for prescription apps

Ironwood signs up with the leading prescription app developer, but Pear is not to everyone’s taste.

Deals

Pear Therapeutics signed a deal yesterday with Ironwood Pharmaceuticals under which it will develop a prescription app to help patients with gastrointestinal diseases in some unspecified way. With the terms of the agreement undisclosed and the exact way the software will work unclear, the deal has a lower profile than the two partnerships it had with Sandoz before the Novartis unit cancelled them two weeks ago.

Landing Sandoz as a partner was a coup for Pear, and losing it was a big blow. The Sandoz deal covered Pear’s Reset and Reset-O, for managing addiction, the company’s only FDA-approved apps – and indeed the only FDA-approved apps in existence – leaving the future of this collaborative approach uncertain. 

Many pharma companies offer digital products to help patients manage their conditions or drug regimens: Pfizer’s LivingWith app, for instance, does both. The difference between these apps and so-called prescription digital therapeutics is that the latter are regarded as having an actual therapeutic effect in themselves, and are regulated and prescribed similarly to drugs (Digital therapeutics have potential but commercial success unproven, August 15, 2019).

Partnering 

Pear in particular has taken the partnering approach with its software development. The Sandoz agreement, set up in April 2018, included cash up front, development funding, commercial milestones, and a profit split on sales of Reset and Reset-O. Sandoz said it was backing out owing to leadership change – the former Glaxo exec Richard Saynor became CEO in August – and a decision to refocus on its core business. Perhaps alarmingly, Mr Saynor was responsible for Glaxo’s digital platforms. 

Pear has retained a separate partnership with Novartis, but this covers earlier-stage apps. The Ironwood collaboration is earlier still. It is Pear’s first foray out of CNS disorders, and it is not immediately obvious how software can have a direct clinical effect on gastrointestinal disorders. 

The Reset apps work by giving patients therapy lessons to teach them to identify situations that make substance use more likely, take responsibility for their choices, think more positively and ultimately avoid the substances. In pivotal trials patients using the apps had significantly higher abstinence rates than patients using sham software. 

It is hard to see how this might work on the symptoms of, for example, irritable bowel syndrome, for which Ironwood’s Linzess is sold.

Pear's pipeline
Product Indication Status Partner
Reset Substance use disorder Marketed None; formerly Sandoz
Reset-O Opioid use disorder Marketed None; formerly Sandoz
Pear-003/Somryst Insomnia/depression Submitted to the FDA None
Pear-004 Schizophrenia  Mid to late R&D Novartis
Pear-007 Pain Proof of concept None
Unnamed Cognition Proof of concept None
Unnamed Epilepsy Proof of concept None
Pear-006 Multiple sclerosis Discovery Novartis
Unnamed Gastrointestinal conditions Discovery Ironwood
Source: company website.

Other digital therapeutics developers are also taking the partnership route. Akili Interactive’s ADHD video game is licensed to Shionogi for the Japanese market, and Click Therapeutics’ depression app is licensed to Otsuka worldwide. Akili’s tech is awaiting the FDA’s approval decision, and Click’s app is in pivotal US trials. 

US approval of these products might do something to reignite confidence in the sector following Sandoz’s desertion, perhaps validating the notion of partnering on digital products.

It should also be noted that pharma companies’ involvement in this sector is not limited to collaborations. Akili and both received venture investment from corporate VCs – Akili from Amgen and Merck KGaA, and Pear from Novartis. Click has been backed by Sanofi and Hikma. Whether Pear will be able to get Novartis’s buy-in in later VC rounds is a question for the future.

Other selected partnered digital therapeutics
Company Product Indication Status Partner
Akili Interactive AKL-T01 ADHD Submitted to the FDA Shionogi
Click Therapeutics CT-152 Major depressive disorder US approval trial Otsuka
Akili Interactive AKL-T02 Autism spectrum disorder Mid to late R&D Shionogi
Dthera Sciences  DTHR-ALZ Alzheimer's disease Mid to late R&D Unnamed Japanese company
Source: company websites and press releases.

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