Daiichi teams up with GAIA for cholesterol DTx in Europe

Daiichi Sankyo's European division has signed a partnership with German digital health company GAIA to sell a digital therapeutic (DTx) designed to support people with high cholesterol levels.

The DTx – called lipodia – is currently in a 272-subject phase 3 trial to assess whether adding it to standard pharmacological therapies can improve reductions in cholesterol levels and improve other health measures in people living with hypercholesterolaemia.

In a joint statement, the two companies said they "aim to address a persistent gap in chronic care [by] leveraging digital technologies to make a difference in patients’ lives by supporting sustainable, long-term behaviour change."

The application uses cognitive behavioural therapy (CBT) techniques to encourage users to adopt beneficial changes in dietary habits, physical activity, and stress, mood, and sleep management, as well as other positive changes like quitting smoking and drinking.

It takes the form of "interactive dialogues", accompanied by illustrations, audio recordings, motivating text messages, and worksheets, to engage people with lifestyle changes that can be beneficial.

Under the terms of the deal, Daiichi Sankyo is getting exclusive rights to lipodia in Europe, which the company said marks the first expansion of its cardiovascular portfolio – which currently includes lipid-lowering therapies Nilemdo/Nexletol (bempedoic acid) and Welchol (colesevelam HCL) – into the DTx arena.

The partnership initially covers Germany as the largest European healthcare market, and includes the option to expand into all other major markets on the continent. The phase 3 DIGICHOL trial is in the final stages, and GAIA intends to submit lipodia for reimbursement in Germany as soon as the results are available. The financial terms of the agreement have not been revealed.

If approved, it will be reimbursed in Germany under the DiGA (Digitale Gesundheitsanwendungen) pathway. Germany was the first country to enable the reimbursement and prescription of DTx on a national level, making it an important market for digital health companies trying to build a sustainable market for their products.

"Our goal is to protect people from cardiovascular disease and help those who suffer from it, so they can enjoy every precious moment that life has to offer," said Oliver Appelhans, head of Daiichi Sankyo's EU specialty business unit. "Digital therapeutics represent an important next step in delivering holistic heart health."

GAIA's other DTx products include deprexis for people living with depression, along with applications for other indications like anxiety, substance use disorders, epilepsy, multiple sclerosis, high blood pressure, arthritis, and cancer.