Issue 211
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 bullets on things happening in FDA-regulated and pharma-focused digital health:
- Brief issue this week as most of the health tech world is heading to Vegas for HLTH (and storing up their news for the show?)
- Amalgam announced that CVS Ventures had participated in the company’s recent Series B — but it didn’t disclose the dollar amount. “In addition to the CVS Health Ventures investment, Aetna, a CVS Health company, is collaborating with Amalgam at select health systems, implementing Amalgam’s EHR-integrated decision support solutions, which are designed to improve outcomes and reduce the cost of care for Aetna members.” More here.
- Virtual care coverage roll-back: As Modern Healthcare reported (sub. req.), Aetna told physicians last month that it would stop paying for a wide array of virtual care starting in December. The change only applies to Aetna’s commercial members. Aetna wrote: “When the public health emergency ended on May 11, 2023, we continued coverage for the liberalized telemedicine procedures/modifiers. Beginning December 1, 2023, we’re modifying our policy to no longer cover some of the liberalized telemedicine procedures/modifiers.” Update: This change focused on coverage of audio-only and asynch text-based virtual care.
- Meanwhile, the DEA has decided to keep one of its public health emergency policy in place for another year: During the PHE, the DEA has allowed “prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient.” While this PHE-era rule was set to expire, the DEA decided to extend it for another year — until December 2024. It was originally set to expire in May, then again on November 11, 2023. The DEA said it made this decision “in light of the need to further evaluate the best course of action given the comments received in response to the NPRMs and the presentations at the Telemedicine Listening Sessions…” More
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Akili CEO and co-founder Eddie Martucci steps down, Chamath Palihapitiya resigns from board
This morning Akili announced that its CEO and co-founder Eddie Martucci has stepped down and Akili’s COO Matt Franklin will take over as president and CEO of the company. Martucci has been with the company since its founding in 2011 and has served as its CEO since 2015. Martucci will become Akili’s board chair following the current board chair, Chamath Palihapitiya’s resignation this week.
Remember: Palihapitiya’s SPAC, Social Capital Suvretta Holdings, took Akili public last year.
In the press release announcing the transition, Akili pointed to the company’s recent pivot from a prescription digital therapeutic go-to-market to a non-prescription model, but the company also hinted at a potential future exit strategy for Akili in its stated rationale for Franklin taking the helm (emphasis is mine):
“He has a proven track record leading early commercialization and growing disruptive healthcare business models in the medical device and diagnostics industries for leading companies such as Boston Scientific, Foundation Medicine, Thrive Earlier Detection and Exact Sciences. As a part of these organizations, Franklin also gained experience in mergers and acquisitions, as both the strategist and the acquisition target.”
Trials: Click-BI, Arcade Therapeutics, Woebot
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.
New: Click Therapeutics and Boehringer Ingelheim’s study on digital therapeutic for treatment of symptoms of schizophrenia
Click and BI just set up a new study to evaluate the efficacy and safety of a second consecutive course of its digital therapeutic for treating the negative symptoms of schizophrenia. Anticipating 216 participants. This builds on the companies’ recently completed study (mentioned below). More:
“Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia. The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.”
Completed: Click and BI’s single-arm study of CT-155 in adults diagnosed with schizophrenia
This study actually finished in December 2022. The total participant count hit 50 — up from the 48 anticipated. More:
“CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia. This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of treatment with an abbreviated version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Participants that meet eligibility criteria will be enrolled in the study on Day 1. The study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.”
Completed: Arcade Therapeutics’ study on mobile game to treat anxiety Arcade Therapeutics completed its study at the end of May. It managed to recruit 150 participants as anticipated. More:
“Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on SAD symptoms, and metrics of functional impairment during this time. After the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.”
Now recruiting: Woebot’s RCT on satisfaction with the BUILD app
This 150 (anticipated) participant trial officially started this week. Woebot is no longer pursuing prescription digital therapeutics as a go-to market, but it is still setting up clinical trials. More:
“This exploratory randomized, double-blind, controlled trial explores user satisfaction with the BUILD mobile application. The BUILD app uses a relational agent (Woebot) to engage users in therapeutic conversations. Eligible participants will be randomized to one of two treatment conditions: (1) an experimental condition in which Woebot uses large language models to understand user sentiment, and based on this understanding of natural language generate responses through a controlled process or (2) a digital control condition in which Woebot selects from a list of responses based on natural language processing. Participants will receive instructions on downloading and using the BUILD app in order to access the intervention to which they were assigned. Participants will use the app as instructed and will complete assessments for the primary endpoint at Week 2 (EOT) with additional measures being collected at Baseline, Day 3, and Week 2. Results from this study will provide preliminary data on user satisfaction and feasibility and inform product development iteration for inclusion in a statistically powered clinical randomized controlled trial.”
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