March 2024 in DTx: most and least discussed updates

#digitaltherapeutics #pulmonaryfibrosis #neurotechnology

This month has been rich in DTx news.?

• An unfortunate shutdown of Better Therapeutics , just less then a month after receiving an FDA breakthrough designation for a digital therapeutic (CBT) designed to treat adults with advanced liver disease. In 2021 Better Therapeutics went public at a $187M eval and in July 2023, the company received FDA authorization for PDTx for adults with type 2 diabetes. Better Therapeutics, however, struggled with commercialization, similarly to Pear Therapeutics - a pioneer in developing DTx for neurological conditions?since 2017 which filed for bankruptcy in April 2023.?

The fall of Better Therapeutics is painful for the digital therapeutics industry which is having difficulties with adoption and with funding decline of 2023, and it is inevitably bringing back all the media discussions on whether the DTx industry is dead or alive.?

However, Sifted has released a list of the DTx companies to watch that consists of some very familiar names like Kaia Health or Closed Loop Medicine together with some new ones. The list shows a great variety of digital therapies both in terms of therapeutic areas (from mental health to menopause and dermatology) and digital health segments (from treatment and monitoring to records management). This diversification gives hope that in 2024 we will see DTx companies finding new approaches and ways to succeed.

• Meanwhile, Almee, a CBT app designed to help ease anxiety in people with?pulmonary fibrosis?(PF) developed by Alex Therapeutics & Vicore Pharma AB , has been granted FDA breakthrough device designation. In January the companies announced positive results of the COMPANION study that enrolled 108 participants at 5 sites in the US?in a randomized, controlled, parallel-group clinical investigation evaluating the impact of Almee on the psychological symptom burden in adults diagnosed with PF. The collaboration between Alex Therapeutics and Vicore Pharma on the DTx development started in 2021.?

The TA of pulmonary fibrosis has had more updates recently: just this January FDA granted de novo clearance to Fibresolve by IMVARIA - an AI program for diagnosing idiopathic pulmonary fibrosis. Digital diagnostic that analyzes chest CT scans for the signs of idiopathic pulmonary fibrosis and aims to help distinguish idiopathic pulmonary fibrosis from other interstitial lung diseases. According to a?previous company study, the early use of Fibresolve was able to reduce the number of lung biopsies within a health system by 41%.

• Another technology therapeutics update is about Alzheimer’s: the paper in Frontiers in Neurology by Cognito Therapeutics, Inc. reveals the results of the OVERTURE study and highlights the effects of Spectris, Cognito’s headset designed to evoke gamma wave activity in the brain, which is impaired in Alzheimer’s patients.?

In my opinion, this is a very interesting development that however has been covered much less than the first two (at least subjectively in my Linkedin feed).

The headset consists of a pair of glasses and headphones and needs to be used for 1 h a day at patients’ homes (at-home use is quite remarkable for this type of intervention). The light and sound are stimulating brain’s activity, potentially helping to preserve brain structure. In January Cognito Therapeutics has raised $35 M (making it $128 M in total) for the development of Spectris.

The OVERTURE clinical trial evaluated the safety and efficacy of Spectris? therapy in participants with mild to moderate AD in a six-month randomized, double-blind, sham-controlled trial. 83% of the OVERTURE study patients (44/53) entered a separate 12-month open label extension (OLE) study, which allowed for further evaluation of Spectris.

The study found that patients on Spectris treatment reported no serious treatment-limiting adverse events, including ARIA (amyloid-related imaging abnormalities). The latter is the problem for all 3 Alzheimer's drugs, designated as “breakthrough treatments": lecanemab, aducanumab, and donanema, as their side effects include ARIA (both brain swelling and bleeding were found present in 12%-35% of patients compared to 3%-13% in those receiving a placebo).

The study demonstrated concordant preservation of brain structure and function among participants receiving the treatment (77% slowing in functional decline, 76% reduction in memory and cognitive decline among others).

This update is particularly curious in the light of latest developments in non-invasive brain stimulation for Alzheimer’s: in October 2023 neuroscientists from the?UK Dementia Research Institute at Imperial College London & 英国萨里大学 have reported the first successful trial of a new form of deep brain stimulation that does not require surgery and could provide a treatment option for brain diseases such as Alzheimer’s (ask Julia Borella for more details).

The new technique, called temporal interference (TI), works by remotely stimulating specific regions deep within the brain by using electrodes placed on the scalp and different parts of the head. According to the study of 20 healthy patients, the technology was able to stimulate the hippocampus – an area of the brain associated with memory – and improve memory function in healthy adults.

Scientists now hope it could soon be used to improve symptoms of memory loss in people living with Alzheimer’s disease and have begun trialling the technique in people with early Alzheimer’s.

It would be exciting to see more developments in the non-invasive Alzheimer’s treatments in the coming years.

In general, Imperial College is the one to follow for more research in the area of Alzheimer: for example, here is the paper from last week reveals insight into the molecular mechanisms underlying vascular changes associated with early Alzheimer’s. The researchers analysed the largest ever dataset generated for vascular cell-specific single nucleus RNA sequencing. They discovered that the expression of Alzheimer’s risk genes was uniquely increased in endothelial cells, a type of cell that lines blood vessels, indicating a major role for these cells in the disease. The research could provide a rationale for dual use of new drugs being developed for cardiovascular disease as treatments for Alzheimer’s.