Issue 170
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…
- The FDA cleared two new versions of New Zealand-based Adherium’s connected asthma inhaler, Haillie, this past week. The agency hasn’t posted the summary document yet, but it is likely the clearance is related to one or both of the submissions that the company mentioned in its annual report last month: “In early August 2022, Adherium announced another submission to the FDA of a 510(k) clearance to market application, this time to connect GSK Ventolin, Advair, and Flovent pressurized metered-dose inhaler (pMDI) users with its next-generation Hailie sensor. Most recently, a further 510(k) … has been submitted, this for Adherium’s fourth next-generation Hailie sensor, connecting users of Teva’s ProAir and Albuterol Sulphate HFA metered dose inhalers.”
- Recent issues of E&O have noted a couple of removals from Germany’s national formulary for prescription digital therapeutics. This week there appear to be three new ones added to it, including the migraine-focused digital therapeutic from Perfood that I mentioned a week ago. At the time, however, I didn’t know its name: “sinCephalea”. It runs €690.00 for 90 days of treatment. More here (in German).
- Germany also added “The Endo App” to its national formulary. The multimodal support program for people affected by endometriosis runs €598.95 for 90 days of treatment. More here (in German).
- Finally, Germany added “re.flex”, a prescription digital therapeutic for knee arthrosis, developed by Romania-based Kineto Tech Rehab, that includes an app and two motion-tracking sensors. For 90 days of treatment, it runs €784.21. More here (in German).
- Worth a read: Last month the US Government Accountability Office (GAO) published a 103-page report named Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning Technologies in Medical Diagnostics.
- One more thing… How the lead sponsor of the Access to Prescription Digital Therapeutics bill, which aims to establish a Medicare benefit category for PDTs, explains the bill to colleagues in one-page.
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Clinical trial updates: Click, Better, Neuroglee, Big Health, Apple-Janssen
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.
News you know: Better Therapeutics completes its pivotal trial for BT-001, a prescription digital therapeutic for diabetes management
This should come as no surprise since Better already announced that it had submitted for a De Novo clearance from the FDA for its digital therapeutic, but the company’s clinical trial page now shows that its pivotal trial finished at the end of September. The company managed to enroll 651 participants. Curiously, the clinical trial page claims that the software is not FDA-regulated as a medical device. Must be a typo or misunderstanding (?). No results yet.
Click Therapeutics post details on new chronic pain study for people with RA, diabetic neuropathy, fibromyalgia, and IBS
Here’s a new one from Click (no collaborators listed for this study) that focuses on the software therapeutic component of a treatment plan for chronic pain. (Assuming the other part is pharmaceutical.) The randomized study aims for 120 participants and includes a placebo control. More:
“CT-100 is a smartphone platform that provides prescription or non-prescription and interactive, software based therapeutic component that may be used as part of a multimodal treatment in future software-based digital therapeutics (PDT/DTx). Scientifically, CT-100 is the Digital Neuro-activation and Modulation (DiNaMo) component that targets key neural systems (including, but not limited to, systems related to cognitive control and sensory-, perceptual-, affective-, pain-, attention-, social-, and self-processing) to optimally improve a patient’s cognitive and mental health. CT-100 a combination of emotion identification and working memory tasks that simultaneously target prefrontal regions and emotion processing regions of the brain. In previous studies, DiNaMo showed clinical efficacy on mood symptoms and improved neurocognitive functioning in patients diagnosed with Major Depressive Disorder (Iacoviello, 2014; Iacoviello, 2018). Based on these results, CT-100 has the potential to assist in the treatment of many indications with high prevalence of cognitive and mood impairments. The purpose of the proposed study is to evaluate initial effects of the CT-100 (the Study App) on measures of pain, pain-related functioning, and mood in pain indications. Chronic pain is a transdiagnostic condition which manifests in patient populations with diverse underlying medical conditions such as rheumatoid arthritis, diabetic neuropathy, fibromyalgia, and irritable bowel syndrome. Results derived from this research could be used as future digital therapeutics.”
Nearly complete: Click and BI’s 7-week feasibility study on prescription digital therapeutic for schizophrenia, CT-155
Click is aiming to completely finish up its schizophrenia study in about a week’s time. The study is a single-arm acceptability and feasibility trial that included nearly 50 participants. More:
“The CT-155 study app is designed to provide treatment monitoring and educational components of a full treatment cycle with CT-155. This design allows inferences to be made about the usability and acceptability of CT-155. Eligible participants will be enrolled during an in-person clinic visit on Day 1. Participants will then be directed to access the study app and perform tasks each day for the 49-day engagement period.”
Now recruiting: Researchers assessing Sleepio for teens at-risk for suicide
Researchers at Rutgers, Old Dominion, and Children’s Hospital of The King’s Daughters are now enrolling about 20 participants in a study focused on the feasibility, accessibility, and effectiveness of Big Health’s insomnia digital therapeutic, Sleepio for teens at-risk for suicide. The study also just widened its inclusion criteria to allow teens to participate who were discharged from the hospital up to three months ago. Previously, the study focused on those discharged within two months. More:
“The purpose of this research study is to test a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called Sleepio, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents.”
No results yet: Neuroglee Therapeutics completed its study on digital therapeutic for mild cognitive impairment (MCI)
I’m still a bit puzzled as to how this intervention is not FDA-regulated, but Neuroglee just updated its study’s posting to show that it completed it at the end of the summer. The study enrolled 55 participants as planned:
“This study is designed to evaluate the preliminary effectiveness and safety of a digitally based multidomain intervention in patients with MCI. In addition, a portion of cognitively normal subjects and caregivers of patients with MCI will also be recruited as an exploratory cohort. We hope that the digital platform will improve the overall cognition and quality of life in patients with MCI.”
Delayed again: Apple’s Heartline study with Janssen just got pushed back another month and is now expected to finish in late November 2025. More:
“The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.”
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