Click Therapeutics, a developer of prescription digital therapeutic products, is adding substance use disorder to its pipeline through a new partnership with addiction medicines maker Indivior.

Like other products in the Click pipeline, the new substance use disorder treatment, codenamed CT-102, will be a mobile software app. This app will be designed to work alongside drugs used to treat addiction. The Indivior portfolio includes the opioid addiction products Sublocade and Suboxone. Click said the partnered app will combine evidence-based behavioral therapy with tailored interventions intended to have an effect on the brain.

Privately held Click is part of a cohort of companies developing software as treatments for various medical conditions. The company has mapped the entire brain to discover faulty brain circuits that are implicated across a variety of diseases. To treat these diseases, the company designs apps that present users with tasks that have the effect of retraining and rewiring the brain.

“We’re trying to discover, develop and commercialize products that have drug-like labels and people can make drug-like claims,” CEO David Klein told MedCity News in a July interview. “We’re creating products for physicians to specifically prescribe. We look at it like we’re creating a new field of medicines.”

A rival substance use disorder digital therapeutic has already reached the market. In 2017, the now defunct Pear Therapeutics’ reSET became the first mobile app to win FDA marketing authorization. But Pear struggled to win insurance coverage for reSET and its other products, leading to a bankruptcy filing. In May, Pear sold its assets in an auction overseen by the bankruptcy court.

Pear’s digital apps were not tested in well-controlled clinical trials. Click aims to ensure that its products show evidence of efficacy through clinical testing. Klein said that while Click is technically a medical device company, he and many of his team members come from drug development backgrounds. Digital therapeutics clinical trials should have the same rigor as traditional drug studies, he said. That rigor is key to winning regulatory approval, market acceptance, and payer coverage, he explained.

Indivior marks Click’s third partner and fourth partnered program. Click has two digital therapeutic candidates for schizophrenia in clinical development under a partnership with Boehringer Ingelheim. A major depressive disorder therapeutic is in late-stage development in an alliance with Otsuka Pharmaceutical.

Like the Boehringer Ingelheim and Otsuka alliances, financial terms of the Indivior deal were not disclosed, but Click said its new partner will make upfront license and development payments. Click could also receive milestone payments plus royalties from sales of an approved product. Click is responsible for clinical development and regulatory filings for CT-102 in substance use disorder. Indivior, which received a global license to the digital therapeutic, will be responsible for its commercialization. The deal also leaves flexibility to develop additional products under the collaboration.

Click has already commercialized Clickotine, a digital smoking-cessation program. The company has another wholly owned program, a migraine digital therapeutic in late-stage clinical development. Klein said Click has a hybrid business model, in which some assets are kept in house while others are partnered with big pharmaceutical companies.

The next step for the Indivior alliance is a “preliminary exploration phase,” during which the partners will define the scope of the product and its match to the needs of patients, physicians, and insurance companies. The companies expect to complete this phase in 2024.

https://medcitynews.com/2023/09/digital-therapeutic-substance-use-disorder-indivior-click-therapeutics/