Akili exits the prescription DTx market, slashing staff

Akili Endeavor OTC

One of the pioneers of the prescription digital therapeutics (DTx) sector, Akili Interactive, has decided to abandon that approach and focus exclusively on a direct-to-consumer business.

The decision – which comes alongside a 40% reduction in staffing levels – is another example of the challenges facing companies trying to build a sustainable DTx business, faced with high entry hurdles and uncertainties in reimbursement, payer acceptance, and healthcare provider adoption of prescription DTx products.

That challenging environment has already led to the demise of Pear Therapeutics, despite having three FDA-approved prescription DTx products, as well as job cuts at other companies, including Better Therapeutics and Biofourmis.

In a statement, Akili said that it has been seeing good growth in consumer demand for the over-the-counter version of its flagship EndeavorRx DTx for attention deficit hyperactivity disorder (ADHD) in its first three months on the market, and will now pursue regulatory approvals for OTC labelling across its product range.

"Today, we are evolving our business to remove barriers for patients trying to access safe and effective non-drug treatment options," said Eddie Martucci, Akili's chief executive, adding that the move will reduce reliance on intermediaries and payers.

"We have the unique ability to offer consumers the same clinically-proven technology as the world's only FDA-approved prescription video game treatment, with the ease of access and convenience of a consumer tech product," he added.

"We believe that our shift to a consumer-led model across our business will maximise our reach in the ADHD patient community and allow us to potentially expand into other large markets, without many of the high cost centres of a prescription model."

EndeavorOTC was launched in June via Apple's App Store, shortly after Akili reported the results of a clinical trial showing that the DTx was effective as a treatment for adults with ADHD, as well as children.

The app is based on gameplay that challenges users to tap targets and navigate obstacles to boost attention and focus.

Since it was released on the App Store it has been downloaded by almost 126,000 users and has 4,170 active subscribers who spent more than $81 on average over the period, generating around $341,000 in revenues.

For comparison, the company achieved revenues of $323,000 in full-year 2022 pursuing its prescription model. For now, the prescription EndeavorRx product will remain available, while Akili works on switching it to OTC status, with a filing for that expected next year.

As might be expected, the job cuts are coming from the company's sales and market access teams, and will help to extend cash reserves out to 2025, said Akili. It now expects operating expenses to fall from $55 million to $60 million this year to between $42 million and $47 million next year.