Under the terms of the agreement, Orexo will hold exclusive worldwide commercial rights to the product, OXD-01, which is expected to be launched in the US in 2022.
Orexo will carry out clinical development, regulatory approval and commercialisation of the digital therapy, while GAIA is eligible for royalties, milestone payments and financial compensation during the development phase.
The new digital therapy will be based on GAIA’s broca technology platform, which is backed by an artificial intelligence (AI)-expert system that involves users in personalised and simulated 1:1 interactions.
The system also guides patients step-by-step to reach certain goals and therapeutic targets.
This individualised approach is said to have a positive impact on therapy outcomes during clinical studies and treatment in real-world healthcare settings and indications.
Broca can run the individualised products on almost any web compatible device, including virtual reality applications. The platform has powered more than 70 products and has been assessed in more than 10,000 patients across multiple clinical trials to date.
Orexo president and CEO Nikolaj Sørensen said: “GAIA’s technology and expertise in digital therapeutics are impressive and makes them an ideal partner for Orexo to develop this new treatment. I am convinced that DTx will become an integral and natural part of addiction treatment in the future.
“This digital therapy for OUD patients is perfectly positioned with Orexo’s competences and commercial organisation in the US.”
Sørensen added that GAIA technology and products have the potential for application in other disease areas that are relevant to Orexo’s existing customers.
In December, the US Food and Drug Administration (FDA) cleared Sandoz and Pear Therapeutics’ reSET-O prescription digital therapeutic for OUD.