Orexo has entered into an exclusive agreement with GAIA for a new digital therapy (DTx) for the treatment of Opioid Use Disorder (OUD).

Orexo will have the exclusive global commercial rights to the product and intends to launch it in the US in 2022, subject to regulatory approval.

“We are delighted to sign this partnership with GAIA, which reinforces the need for a complete treatment plan for OUD patients. 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 organization in the US. GAIAs technology and products can potentially be applied to several other disease areas relevant to Orexo’s current customers and we look forward to continuing our dialogue with GAIA on other possible DTx that can be commercialized by Orexo,” says Nikolaj Sørensen, CEO and President of Orexo.

Highly individualized products

The medically assisted treatment of OUD requires a complete treatment plan, including effective medication, and counseling and psychosocial support. The access and quality of counseling and psychosocial support remain one of the main barriers to successful treatment in many areas of the US. Orexo believes that the fully-automated DTx (Orexo project no. OXD-01) can become a valuable addition to existing treatment plans, which will improve patients’ access to treatment and overall treatment outcomes.

OXD-01 will be powered by GAIA’s technology platform broca, which has been the backbone of more than 70 products and been tested on more than 10,000 patients during clinical trials to date. Based on an artificial intelligence (AI)-expert system, broca engages users in highly individualized, simulated 1:1 interactions, guiding patients step-by-step towards specific goals and therapeutic targets. This individualization makes GAIA’s products unique and has proven to have a significant positive impact on patients’ treatment outcomes during both multiple clinical trials and actual treatment in various healthcare settings and indications around the world. GAIA’s broca platform has the flexibility to run the highly individualized products on nearly all web compatible devices, including virtual reality applications.

Terms of the agreement

Under the terms of the agreement, Orexo will be responsible for the clinical development, regulatory approval and commercialization. GAIA will be entitled to royalties, milestone payments as well as financial compensation during the development phase. Orexo will provide an updated cost guidance for 2019 in connection with the Q3 report release, the increase in the operational expenses for 2019 is expected to be non-material. Future expenses related to OXD-01 will be incorporated into Orexo’s overall cost guidance.

Photo of Nikolaj Sørensen: Jenny Öhman