Issue 196
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 are a few quick happenings in FDA-regulated and pharma-focused digital health…
- Last week I noted that Germany’s national formulary for prescription digital therapeutics (DiGA) had lowered the price of Zanadio, a digital health program for obesity, from €499.80 to €218. An important quirk of the DiGA program (that I didn’t realize existed until last week — thanks to the reader who flagged it for me) is that when a price change like this occurs, the developer of the digital health program needs to refund the price difference to the health plans for any prescriptions written and paid for during the digital health program’s second year in the DiGA program. This is oversimplifying it, but the company can set its own price for year one, but if negotiations with health plans lead to a lower price for year two — that only gets figured out months into that second year during which the original price is in place in the meantime — those Euros get clawed back. So, in this case, Zanadio’s developer, aidhere GmbH, has had to file for insolvency (bankruptcy) in Germany. The company was on the hook to pay back between €9 million and €10 million because of its year two price change. And… it couldn’t. So, prescription digital therapeutics companies are going bankrupt in Europe too (and blaming payers for it).
- As expected, Akili’s EndeavorRx is now waiting on the FDA to expand its label to older kids aged 13 to 17. The company submitted to the FDA on May 8th, so I’d guess the agency will issue that 510(k) sometime this summer. EndeavorRx is currently only available to kids aged 8-12 via prescription. An interesting shift for Akili, however, is still a ways off when it gets an FDA OK to expand into the adult population where it has said it would focus more heavily on a direct-to-consumer telemedicine go-to-market.
- Akili’s Q1 results continued to follow the company’s slow growth to date. It only brought in $113,000 in revenue during the three months. It counted 920 unique prescribers for EndeavorRx during the quarter and 2,372 prescriptions in total for the quarter.
- The FDA quietly cleared a new version of EKO’s smart stethoscope called the CORE 500. No details yet on what changed in this new version of the device.
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Trials: Twill completes Ensemble RWE. Click recruiting for migraine study. Terminated trials.
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others mentioned in previous issues. It’s been a few weeks so this round-up is going to be a big one…
Twill completes Ensemble RWE study. FDA submission soon?
Twill, the company formerly known as Happify, has completed its real-world evidence study of HPDT-DA-013, also known as Ensemble, a prescription digital therapeutic that treats major depressive disorder and generalized anxiety disorder. While the company hasn’t commercially launched Ensemble yet, Twill launched this study during the public health emergency and under the FDA’s enforcement policy for digital health devices that treat psychiatric health. Twill wrapped up the trial early with fewer enrolled participants — 367 — than it originally anticipated because it felt it had gathered sufficient data to submit to the FDA. Twill’s study finished up April 2023, a year ahead of its original “anticipated completion date”, but the company still needs to conduct a 12-month follow-up with this study’s participants to determine Ensemble’s cost-effectiveness. More:
“This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.”
Click Therapeutics now recruiting for study on prescription digital therapeutic for preventing migraines
Click is now recruiting for an RCT that includes two prescription digital therapeutics focused on preventing migraines (one is likely a sham, right?). More:
“The purpose of this randomized ReMMi-D trial is to evaluate the efficacy and safety of two prescription mobile applications that provide an interactive, software-based intervention for the preventative treatment of episodic migraine in late adolescents and adults.”
Duke researchers are studying a quasi-diagnostic app for autism spectrum disorder
Watch out Cognoa, here comes Duke’s SenseToKnow app. This 350-participant study doesn’t seem to be leading toward an FDA submission, which is puzzling. (Not sure why the researchers didn’t check the box designating this an FDA-regulated medical device.) More:
“This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the classification of autism spectrum disorder when administered by parents in a sample of patients 16-36 months of age. The trial design is a non-interventional cross-sectional study comparing the SenseToKnow app classification of autism spectrum disorder (“autism”) versus non-autism with the patient’s diagnostic status based on expert clinical diagnosis in a population of pediatric patients.”
Completed: Montefiore’s study of UnitedHealth’s Sanvello mental health program on irritable bowel syndrome
This study just finished up. It got its start back in 2021, but it’s the first time I’ve seen Sanvello used specifically for IBS patients. More:
“Given the bidirectionality between psychological distress and disease activity in inflammatory bowel disease (IBD), whereby increased psychological distress exacerbates disease activity and vice versa, psychosocial aspects of IBD care are receiving increased attention. However, proposed interventions are generally resource-intensive and have been tested in majority white populations. While people of color are an increasing segment of the IBD population, they are currently underrepresented in research studies. The purpose of this study is to evaluate the efficacy and implementation of internet-based cognitive behavioral therapy (iCBT) among IBD patients of color with elevated psychological distress.”
Completed: Novo Nordisk’s Ksana Health-powered health coaching program for young adult mental health and obesity
This study is focused on a health coaching program that is unrelated to Novo’s GLP-1s. More:
“The primary aim of this project is to examine the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in a 2 x 2 (gender x condition) designed pilot study in a sample of 100 youth (18-25 years old) with (1) elevated depressive symptoms (PHQ-8 score ≥10) and (2) overweight/obesity (BMI ≥ 25 and/or reporting a parental history of overweight/obesity). The study will examine the feasibility and utilization of the mobile app intervention with coaching compared to that of the mobile app intervention without coaching.”
Terminated: Limbix Health’s SparkRx study with adolescents treated in-hospital at Children’s Hospital of Los Angeles
After only recruiting two participants out of an anticipated 40, Limbix Health terminated a study on SparkRx used to treat depression in adolescents admitted to hospital for cardiology and GI conditions. More:
“The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children’s Hospital of Los Angeles (CHLA).”
Completed: Akili’s COVID brain fog study
Akili finished up its 110-person study on using a version of EndeavorRx in a population of COVID survivors. More:
“The primary objective of this study is to investigate the efficacy of AKL-T01, a remotely-delivered digital cognitive intervention, relative to a waitlist control in improving cognitive functioning in COVID-19 survivors.”
Withdrawn: Akili’s Endeavor study for kids with MS
Akili and the study sponsor NYU Langone Health have withdrawn their study on Endeavor for kids with multiple sclerosis. The companies cited “insufficient funds and limited staffing to complete the pilot program” as the reason for the pull back. More:
“This study will examine the feasibility of using an Endeavor application as a treatment modality for cognitive impairments in the pediatric MS population. Participants will be asked to undergo a hour-long baseline evaluation, followed by at-home Endeavor application sessions. Subjects will complete the User Experience Feedback Form weekly on REDCap and at the end of the study. They will undergo another hour-long follow-up evaluation at the end of the study.”
Withdrawn: Koa Health’s study with MGH on social anxiety disorder
Koa didn’t provide a reason for withdrawing its study other than a note that it was no longer proceeding with it. More details here but here’s a quick blurb:
“The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).”
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