Issue 161

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.

Here’s what’s going on in FDA-regulated and pharma-focused digital health:

• Question for you: Pear CEO Corey McCann MD was a guest on Eugene Borukhovich’s other podcast, Shot of Digital Therapy, this past week and he made a provocative declaration: “In the spirit of complete and utter candor, a bunch of companies are moving the space backward too. You can’t open a press release without [reading] wild claims. I think the world is confused. To use an American football term, there are a bunch of parts of the space that have out-kicked their coverage. There are some companies that are making some crazy claims on the basis of data that isn’t there.” McCann made this charge after expressing his admiration for the teams at MedRhythms and Akili. So, clearly, he didn’t mean either of those, but I’m curious since it is not obvious to me: Which companies do you think he was referring to? If you want to respond via encrypted chat, you can always find me on Signal at 617-416-4689.
• Speaking of Akili: The company just announced the start of its 150-participant Phase 3 trial in Japan with its Japanese pharma partner Shionogi. From the release: “…a pivotal Phase 3 randomized, controlled study of SDT-001 (a version of AKL-T01 localized for Japanese language and culture), a product candidate designed to improve measures of attention in children diagnosed with attention-deficit/hyperactivity disorder… designed to evaluate the safety and efficacy of the product candidate in children ages 6-17 with ADHD as a registration-enabling trial. Clinical trial sites have begun enrolling patients, and results of the study are expected in 2H2023.”
• Related: Frontiers in Psychiatry published a worthwhile opinion piece and mini-meta-analysis of Pear and Akili’s clinical trials focused on their engagement and attrition rates: “Mental health conditions, like major depressive disorder, ADHD, and PTSD, require sustained treatment. Because the field of digital therapeutics is still in its early stages, currently, there is little long-term efficacy data. If even well-designed, gamified, digital therapeutics have a 50% drop in engagement in 3 months then the outlook for long-term efficacy is grim. While drop-out rates in clinical trials can be kept low through frequent clinician contact, gamification, feedback, and cash incentives, this is not practical in the real world and hence attrition rates will be far higher. Finally, if the costs of increasing engagement and compliance equals that of a getting live psychiatric care, then digital therapies would become less attractive as a scalable low-cost solution.” (This worthwhile report in STAT called my attention to it.)
• Big launch news: Natural Cycles has finally launched its partnership with Oura ring. It was almost exactly one year ago that E&O analyzed (Issue 113) this unusual partnership where a SaMD (software as a medical device) product (Natural Cycles) had received a new 510(k) that included a non-FDA regulated sensor (Oura ring) as a validated input source. After a year in private beta to test the combo offering, the two companies just launched it commercially this week.
• FDA 510(k) scoop of the week: Bodyport quietly secured a 510(k) for its Cardiac Scale, which measures and tracks “body weight, peripheral impedance, pulse rate, and center of pressure.” It is Rx-only and set to power the company’s virtual cardiology clinic. Here are the full indications for use: “The Bodyport Cardiac Scale is intended for use, under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management-related health conditions. The device is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure. The device is intended to be used in the home or clinic environment. Intended users are people over 21 years of age who can stand for the duration of the measurement and weigh less than 180 kg (397 lbs). The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient’s status.”
• Meanwhile, the American Psychological Association (APA) has successfully flooded the proposed CMS Physician Fee Schedule for 2023 with form letters (I count more than 700!) from mental health clinicians that all close with this passage on digital therapeutics: “I urge CMS to accept APA’s proposal that would establish a new set of reimbursement codes for digital therapeutics—one for purchase of the device, one for patient education about the device, and two for ongoing management of the service furnished through the device. Unlike the RTM codes, this structure reimburses for an active therapeutic intervention, as opposed to passively monitoring a patient’s condition. A new set of reimbursement codes as outlined above will have a positive impact on access to treatment amongst patients who have limited access to traditional office-based treatment or who prefer the use of digital devices over a face-to-face visit.” And you can too…
• The FDA is taking applications from digital health companies that are open to a virtual visit to educate the agency about the market. The two digital health-related areas of interest that the FDA listed are both pretty broad: “Novel Digital Health Technologies and Therapy” and “Real World Data and Evidence”. More details here along with how to apply.
• One more thing… ResMed Germany has acquired Germany-based Mementor, developers of Somnio, a prescription digital therapeutic for insomnia that is listed in Germany’s DiGA formulary. (Hit reply — or head to Signal — if you know the financial details.) It is tempting to speculate that ResMed plans to scale Somnio up and across the many international markets it is operating in today, but the press release gives every indication that this deal is squarely focused on the German market right now. Curious to see if that changes though.

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$2B vs $7M: Comparing venture investment to product revenues for prescription digital therapeutics

Last week a reader at a pharma company asked me if I had two figures handy:

• Total venture investment into prescription digital therapeutics companies to date
• Total product revenues generated by prescription digital therapeutics to date

A few days later we compared notes and arrived at about the same two numbers. These were mine:

• Total investment into PDTs: $2 billion
• Total product revenue from PDTs: $7 million

There are many caveats that go into these numbers starting at where you draw the lines on the definition of prescription digital therapeutics.

For starters: You could shave off at least $500 million in investments by arguing that some of the companies developing PDTs today also have consumer businesses or remote patient monitoring businesses, so only a small percentage of their funding should count. The number is still well over $1 billion though.

And, of course, the bulk of the product revenue numbers come from Pear Therapeutics and Akili. But maybe that $7 million should be lower: For example, should Pear’s deals with state Medicaid programs that pre-purchased prescriptions in bulk count? Or maybe higher: Both of those companies should release new product revenue figures for Q2 in the coming weeks, so that number will certainly eke up a bit.

Clinical trial updates from Akili, Oui, Limbix, Woebot, and Click

This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.

Done recruiting: Akili’s STARS-ADHD-Adolescents study

In addition to the Shionogi study news mentioned up top, Akili has finished recruiting for its STARS study, which is investigating its prescription digital therapeutic in teens aged 13 to 17 years old. The company aimed to enroll as many as 165 participants, but it did not confirm the number as part of its study listing update:

Oui Therapeutics to study its suicidal ideation digital therapeutic for in-patients

After coming out of stealth last week, prescription digital therapeutics company Oui Therapeutics continues to make moves. This week it posted details on a new (four-participant) feasibility study with Hartford Hospital that shows it is developing a version of its prescription digital therapeutic for people still in-hospital:

Click and BI to test out an abbreviated version of their prescription digital therapeutic for schizophrenia

This new 48-participant study aims to test the acceptability and feasibility of what the company calls an “abbreviated” version of its digital therapeutic. With the exception of the abbreviated version of the PDT, this study is close to a carbon copy of the one E&O wrote up in Issue 156 a month ago. That original study is not yet recruiting, however, while the new study began recruiting immediately:

Woebot posts details on a new study of teen depression digital therapeutic program

This new 274-participant study from Woebot has three aims:

Woebot is currently recruiting for another study that compares WB002 to “CBT-light” teletherapy. It completed its first study on WB002 at the beginning of the year.

Limbix pushes back SparkRx study start from July to September

Here’s more on the study:

Now recruiting: Finnish digital therapeutic study for major depressive disorder 

Finnish researchers are now recruiting for a study on a digital therapeutic for major depressive disorder named Meloria. (As far as I can tell, this has nothing to do with the US subsidiary of the UK’s Helios, which goes by the same name.) More on the study:

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