Issue 167
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 this week in FDA-regulated and pharma-focused digital health…
- Just a patent: Remember, Apple hasn’t even introduced a VR/AR device yet, but… Patently Apple noticed that Apple secured a patent this week that shows its R&D team has explored using a virtual reality or augmented reality head-worn device to help detect cognitive decline or Alzheimer’s. Here’s a lengthy excerpt from the patent filing: “Head-mounted devices of the present disclosure can provide non-invasive mechanisms for detecting and responding to symptoms of cognitive decline… The head-mounted device includes hardware (e.g., display, camera, microphone, eye-tracking device, etc.) that facilitate the determination of diagnosis and prognosis and allow meaningful feedback to a user. The head-mounted device can detect and respond to a user’s expressions of aphasia, for example by determining whether a user is speaking the wrong words to refer to subjects identified by the head-mounted device. The head-mounted device can detect and respond to a user’s expressions of apraxia, for example by determining whether the user is failing to interact with objects for which the user is reaching. The head-mounted device can detect and respond to a user’s expressions of agnosia, for example by determining whether the user is putting items where they do not belong.”
- Better Therapeutics announced that it had submitted its prescription digital therapeutic for Type 2 diabetes to the FDA via the de novo pathway.
- Mini-scoop: The FDA cleared Eli Lilly’s Tempo Smart Button, which attaches to the company’s Tempo Pen, a modified version of Lilly’s existing prefilled, disposable insulin pen. (As far as I can tell, the company hasn’t announced this 510(k) clearance yet.) The Smart Button adds connectivity to the insulin pen enabling it to stream data to Lilly’s partners’ apps, including ones from Dexcom, Roche’s mySugr, Glooko, and MyDiabby. More info in this old press release about those app partnerships here.
- Big Health’s Co-Founder (and former CEO) Peter Hames got back to me about my speculation last week that the company’s latest study tees it up for an FDA submission for Sleepio. Hames would not confirm that Big had made the decision to seek out an FDA market authorization, but he did confirm that the study “definitely gives us optionality with regards to the end of the [public health emergency].”
- The Digital Therapeutics Alliance organized another trip to Capitol Hill this week — presumably to evangelize the House and Senate bills that would create a new Medicare benefit category for prescription digital therapeutics. Perhaps not coincidentally, the House version of the bill, H.R.7051 Access to Prescription Digital Therapeutics Act of 2022, added a new co-sponsor this week: Republican Rep. Ted Budd (R-NC).
- Akili launched a direct-to-patient registry for its ADHD-focused prescription digital therapeutic, EndeavorRx: “This fully remote, direct-to-patient registry is open to any patient who has been prescribed EndeavorRx by their healthcare professional and will provide insights into patient characteristics, usage patterns, and effectiveness of EndeavorRx in a real-world setting. Data from the registry will also be used to help improve the experience and education around the product for patients and caregivers, and enable Akili to iterate its product based on feedback and data received via the registry.”
- This week metaMe quietly launched a new website for healthcare providers that offers up information and FAQs about its prescription digital therapeutic for IBS pain, Regulora.
- In vitro diagnostics company bioMerioux has tapped BrightInsight “to develop and bring to market a clinical digital solution for diagnostics enabling clinical decision support for disease areas across their diagnostic tests.” The companies expect the digital CDS tools to launch in the US market first. More here.
- One more thing… HumanFirst released a new open-access database of digital measures that sponsors could use in clinical trials. HumanFirst described the massive project as including “25 measure ontologies covering 11,000+ digital measures across 800+ medical conditions.” Read more about it here.
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Mahana Therapeutics statement on its freemium model for prescription digital therapeutics
A few weeks ago I puzzled over Mahana Therapeutics’ freemium onboarding model for its FDA-cleared, prescription-only digital therapeutic, Mahana IBS, which treats irritable bowel syndrome. Here’s what I wrote at the time:
“Is a freemium business model an option for prescription digital therapeutics companies? Mahana Therapeutics seems to have figured out a way. Here’s how the company’s app description in Apple’s AppStore suggests people get started:
‘Get started now: You can start your first session with Mahana IBS now. To continue with the next session you will need a prescription through our simple & easy telehealth consultation or your healthcare provider.'”
Given that the first session is included in the medical device description listed with the FDA, I was curious if this freemium set-up had received the FDA greenlight. I asked Mahana for an explanation, including whether they had discussed this plan with the agency. They just got back to me this week:
“The first module of Mahana IBS is non-therapeutic and educational only, giving individuals with IBS information that they can share with their physician for a discussion about whether gut-directed cognitive behavioral therapy could be a good option for them. No one is able to progress into the therapeutic component of Mahana IBS — which starts at module two — without a prescription. Therefore, access to the FDA-cleared and regulated components (i.e., the therapeutic components) of Mahana IBS can only be accessed by individuals who fall into the cleared product indication. Because Mahana IBS is regulated as a medical device, Mahana is not required to receive FDA review and clearance for promotional components or materials associated with it, such as the non-therapeutic/educational first module.”
I see the rationale here, but it still seems unprecedented as a marketing strategy for companies with a prescription digital therapeutic go-to-market.
After digging around a little, I did find that Akili has a somewhat similar set-up with its EndeavorRx app. If you were to download that app today — without a prescription code to unlock it — you could play a demo version of the EndeavorRx game. Akili doesn’t seem to be marketing that as a reason to download the app prior to an Rx, however.
Clinical trial updates: Janssen, Woebot, Pear, and MedRhythms
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.
Woebot tapped IQVIA for new study that evaluates efficacy and safety of its digital therapeutic as an adjunct to TAU in postpartum depression
This study aims to enroll 210 participants and will randomize them into groups using the digital therapeutic plus treatment as usual (TAU) and an education content control app plus TAU. More on the study:
“This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression… Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).”
Click Therapeutics completed study on digital therapeutic component that treats cognitive functioning and mood symptoms
Click managed to enroll 114 participants into the study, which originally hoped for 120. The study included patients with various medical conditions, including multiple sclerosis, breast or lung cancer, and patients with mild cognitive impairment. More on the study:
“The purpose of the proposed basket study is to evaluate initial effects of the CT-100-001, a DiNaMo component (the Study App) on cognitive functioning and related outcomes compared to Care-As-Usual across several non-DSM-5 indications. These indications have known high prevalence of cognitive impairments due to the illness and/or treatments. such as in Multiple Sclerosis, Breast or Lung Cancer, and Mild Cognitive Impairment.”
Boston University’s MedRhythms study on a digital therapeutic for Parkinson’s Disease tweaked outcomes measures
BU’s MedRhythms study removed Quality of Life in Neurological Disorders (Neuro QoL) from its long list of outcomes measures, but added one for Mini Balance Evaluation Systems Test (MiniBESTest). Read more of the details of the AMPED-PD study here.
Columbia University and Pear Therapeutics raised the maximum age for their Spanish language Somryst insomnia study
Columbia University’s study of the Spanish language version of Pear Therapeutics’ prescription digital therapeutic for chronic insomnia, Somryst, just raised its maximum age of participants from 65 to 75 years old. More on the study:
“The primary objective of the proposed study is to examine the effectiveness of a culturally adapted digital program of cognitive behavioral therapy for insomnia (CBT-I) compared to minimally enhanced usual care (mEUC) on primary outcomes: reduction in insomnia symptoms at 9 weeks and 6 months post-intervention, using a standard scale among Spanish-Speaking Latina/o adults with chronic insomnia.”
Withdrawn: Janssen R&D shut down study that paired digital cognitive behavioral therapy with Esketamine in participants with treatment-resistant depression
Janssen withdrew its study — Assessment of Feasibility of Using Clinician-Directed Cognitive Behavior Therapy Supplemented by a Digital Application in Conjunction With Esketamine (SPRAVATO) in Participants With Treatment-Resistant Depression — for the following reason: “due to budget decision and wanting to pursue other research priorities.” Janssen hadn’t yet recruited for the study prior to the withdrawal. More details here.
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