Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.

 E&O Fridays.

For today’s issue, I spent some time digging into the pipelines of prescription digital therapeutics companies. Since I started tracking those a year ago, I was able to find some interesting product strategy shifts at a number of companies.

OK, here’s what’s happening this week in the world of pharma digital products and FDA-regulated digital health:

• After 3.5 years at the company, Pear Therapeutics Chief Strategy Officer Alex Waldron departed this month. He is now the CEO of Wellinks, a virtual COPD care company that also offers a connected nebulizer device. (Pear’s strategy right now is pretty straightforward: Get payers to pay for its three commercial products. So, the departure has a certain logic to it.)
• Another longtime Pear exec, VP of Corporate Development Antoun Nabhan left in November to join Oaktree Capital Management as an SVP. Among other things, Nabhan helped source Pear’s insomnia therapeutic, Somryst, and license it from its original creators.
• There were a number of interesting studies out this week, but the big one was the Otsuka-Verily-Click Therapeutics Mirai study. While the companies are trying to keep a lid on the details, you can glean quite a bit from the study’s homepage on the Project Baseline site here.
• The other big study this week wasn’t just announced — it published results. A remote COVID-era, double-blinded study of AppliedVR’s eight-week program and digital therapeutic EaseVRx had promising results for the 179 participants who all reported experiencing chronic low-back pain for at least six months prior to enrolling. While the results are interesting, AppliedVR also noted that EaseVRx, which has Breakthrough designation from the FDA, is also angling to take advantage of the new MCIT reimbursement pathways. I guess there’s a Medicare benefit category that EaseVRx fits into?
• France-based Lucine is now recruiting for a clinical trial of its VR-based digital therapeutic, EndoCare, to help people mitigate pain that comes with endometriosis.
• OK, one more: Constant Therapy Health, which spun back out of The Learning Corp. and its acquirer Digital Health Corp. last August (Issue 065), published results from a small study that showed its digital therapy beat paper-based therapy for aphasia.
• Eli Lilly tapped Welldoc to license and integrate its BlueStar insulin management software into Lilly’s forthcoming connected pen platform.
• I was on a panel at DTx West this week about the state of clinical evidence for digital therapeutics. The discussion had a particular focus on equity. One point I was hoping to make before time ran out was that the AMA’s new CPT codes for remote therapeutics services (Issue 085), which seem likely to cover some digital therapeutics, appear to include two codes related to “device supply”. These still need to make it on the CMS Physician Fee Schedule, but there’s a possibility those codes make it possible to pay for the devices needed to access digital therapeutics. That’d be a big leap forward for Medicaid and Medicare patients. (Why two codes? One for a tablet and one for a sensor? One for a tablet and one for the cellular data plan? A veritable CPT mystery, friends.)
• One more thing… Bunny Ellerin’s must-read annual report on the state of NYC digital health is out now.

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Blue Note quietly launches attune, its flagship prescription digital therapeutic for cancer patients under the FDA waiver

Blue Note Therapeutics very quietly set-up a patient-facing marketing site for attune, its pre-FDA prescription digital therapeutic for cancer patients dealing with anxiety or depression.

As the marketing copy makes clear, patients need to ask their own doctor for attune, Blue Note hasn’t set-up a telemedicine-based prescription channel yet. Blue Note did launch a similar program under the FDA waiver last year, COVID Cancer Care. The company described that offering as a “preview” of its prescription digital therapeutics. COVID Cancer Care was freely available, no prescription needed. The attune launch looks like Blue Note has decided to go for it with its flagship therapeutic. Check out the attune website here.

Launching during the pandemic under the FDA waiver is not without its risks, especially if this launch comes close to the end of the time period when that waiver is in effect. If you missed it, read more about the potential risks of a launch like this pre-FDA from last April’s Issue 048.

Happify Health’s therapeutic areas include MS, psoriasis, RA, cancer and diabetes

Happify Health keeps its pipeline of digital therapeutics quieter than most, but the company has announced partnerships with Sanofi — for a digital therapeutic for people with multiple sclerosis — and Almirall — for a digital therapeutic for people with psoriaris — so far. Regardless of the therapeutic area, Happify’s therapeutics typically use CBT, mindfulness, and positive psychology to target comorbidities like stress, anxiety, and depressive symptoms.

While the company hasn’t made any announcements around these yet, from what I have seen in job postings and other hints elsewhere on the internet, I believe the company also has digital interventions in the works for people with rheumatoid arthritis, cancer, and diabetes.

Woebot pulled WB004 adult depression digital therapeutic from its pipeline

When I first started tracking prescription digital therapeutic pipelines last year, Woebot Health had four products in the hopper. Now, the company has three and it has reshuffled some of its candidates’ names. Last year Woebot’s four products in development were:

• WB001 for post-partum depression,
• WB002 for substance use disorder,
• WB003 for adult depression, and
• WB004 for adolescent depression

Today, the pipeline includes just three products:

• WB001 for post-partum depression
• WB002, which is now its adolescent depression (mild to moderate) DTx
• and a Substance Use Disorder offering that no longer has an assigned candidate name

Cognoa pulled its pediatric insomnia DTx and added two language-focused ones. Plus: “Canvas” looks to be its brand for its autism offerings

Cognoa also pulled one of its candidate digital therapeutics from its pipeline, but this one focused on pediatric insomnia. It was at the clinical development stage. Cognoa also added two new products to its pipeline: A speech and language diagnostic that is at the early clinical development stage and a speech and language therapeutic that is still in discovery.

And a trademark filing indicates that the brand for Cognoa’s autism digital diagnostic and autism digital therapeutic will be “Canvas”. The Dx will likely be named Canvas Dx and the therapeutic will likely be named Canvas ASD.

GAIA trademarks point to DTx for MS, acne, sleep, bipolar disorder, breast cancer, hypertension

I mentioned this last week, but GAIA’s online program for depression, deprexis, is now officially listed in the German government’s reimbursement formulary, DiGA. The price is $360 for 90 days of use. The product is one of the few that has a permanent listing. Trademark filings over the past year indicate a long list of new digital therapeutics may be coming from GAIA.

Here’s a quick rundown:

Ilucia. This digital therapeutic is “especially for women” (what?) according to GAIA, “with skincare concerns in the nature of acne, wrinkles and dull skin” and it offers “behavioral change therapy in order to reduce chronic stress, increase immune-boosting positive moods and psychological resilience, improve dietary habits and exercise regularly.” Reclarit. This is another DTx brand focused on “autoimmune diseases of the skin.”

Captida and Levidex. These two marks are for GAIA’s MS offerings. Here’s a snip from the Captida filing but Levidex is similar: “Facilitating the teaching of science and medicine, for permitting interaction between patients and healthcare professionals in the field of management of multiple sclerosis.”

Somnovia. This is a sleep-related DTx that is focused on psychological issues preventing a good night’s sleep. The trademark mentions software for “collecting, analyzing, and managing medical information and for facilitating sleep therapy and sleep training.”

Alivis. This is GAIA’s anxiety-focused DTx brand: “Software programs for the treatment of mood disorders and anxiety disorders” and the filing also mentions bipolar.

Optimune. This one is software “for the treatment of breast cancer for use in strengthening and supporting the human immune system.”

Liebria. This is GAIA’s DTx brand for high blood pressure.

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