Issue 122
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 going on this week in FDA-regulated and pharma-related digital health:
- Limbix became the latest prescription digital therapeutics company to launch a PDT pre-FDA clearance under the agency’s enforcement policy for medical devices focused on psychiatric disorders. This is actually another quasi-launch since Limbix isn’t charging for access yet. (And I’m a bit sore about this, because I had this one in the hopper earlier in the week as a scoop for today’s issue. And the company officially announced it this morning!) “SparkRx is rooted in cognitive behavioral therapy, a therapeutic modality proven to assist with the symptoms of depression and other mental health disorders. SparkRx is an adjunct treatment for teens and young adults aged 13-22 who are experiencing symptoms of depression… SparkRx is accessible via a health care provider and available at no cost to patients for a limited time.” As E&O has reported in past issues: Other companies that have launched a PDT (or at least partially launched) thanks to this FDA enforcement policy include Akili Interactive, Pear Therapeutics, Orexo, Blue Note Therapeutics and Happify.
- As I mentioned last week, one soundbite that jumped out for me from the DTx East event last month came from Ryan Lawton, Chief Architect, Blue Shield of California: “One challenge, even in the prescription digital therapeutics space, is that while they have shown efficacy they haven’t quite figured out yet how not to contribute more to medical spend. This idea of replacement therapy is an idea that still needs a tremendous amount of focus.” A reader pointed to the FDA as the main obstacle here since the agency currently requires prescription digital therapeutics to be labeled as “adjunctive” and won’t let PDT companies claim that their products can be replacements for medication or in-person therapy. It’s been a while since I’ve heard a specific complaint about the FDA holding back digital health, so figured I’d share it.
- Click Therapeutics filed a trademark this week for Click DiNaMo, which is a brand focused on behavioral health services “for treating human health conditions, behaviors, and diseases using digital therapeutics.”
- Sonde Health, which came out out of PureTech Health just like Akili, has commercially launched “Sonde Mental Fitness, a voice-enabled mental health detection and monitoring technology that uses a brief voice sample to evaluate mental well-being. Available as an application programming interface (API) for health systems, employers, and wellness service providers, Sonde Mental Fitness is an easy and affordable way for individuals to engage with and better understand their mental well-being and can serve as a much-needed early warning system for depression and other mental health conditions.”
- In an update to its S-4 filing as part of its SPAC merger, Pear offered a few updates on its progress. The company went from 200 full-time employees at the end of June to 250 at the end of September. It also noted that its PDT for schizophrenia progressed from the Proof of Concept stage to the Pivotal stage of development. Finally, Pear assigned candidate numbers to a few of its PDTs under development: PEAR-009 is focused on alcohol use disorder (and it’s no longer called reSET-A in the document). PEAR-011 is its GAD prescription digital therapeutic. And PEAR-015 is its MDD candidate.
- One more thing… Monday is a holiday here in Massachusetts so expect something in your inbox on Tuesday instead.
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Anticipated launch dates for seven prescription digital therapeutics between now and 2024
A recent presentation that Pear Therapeutics’ Head of Health Economics and Real World Evidence Fulton Verez gave listed out seven prescription digital therapeutics that are in the hopper and set to launch between now and 2024.
According to Verez, here’s a rundown of anticipated launch dates for seven PDTs:
- Q3 2021: Luminopia’s PDT for treating amblyopia (this one is technically late now that we are in October)
- (Just an aside to point out that Pear anticipates no PDT launches in 2022)
- Q2 2023: Click Therapeutics’ PDT for treating major depressive disorder
- Q2 2023: MedRhythms’ PDT for stroke rehabilitation
- Q3 2023: Orexo’s PDT for treating depression
- Q3 2023: Better Therapeutics’ PDT for treating symptoms in diabetes
- Q1 2024: Akili Interactive’s PDT for treating symptoms in autism spectrum disorder
- Q1 2024: Pear Therapeutics’ PDT for treating symptoms in irritable bowel syndrome
Which prescription digital therapeutics are missing from Pear’s list?
Trial updates: BMS, Neuroglee, MedRhythms, Apple, Remedee
Here’s E&O’s weekly roundup of changes and additions to clinical trials focused on FDA-regulated digital health devices and other pharma-related digital health.
Verily and UCB Pharma’s Parkinson’s study adds details to outcomes measures
Until this week, this study was thin on details but it now includes descriptions for seven primary outcomes measures and twelve secondary ones. (Remember, this study comes in the wake of the FDA rejecting Verily’s application to use its Study Watch as a “Virtual Motor Exam for Parkinson’s disease” back in June.)
Check out the study’s page here to read through the detailed descriptions of its outcomes measures, and here’s a refresher on the study’s focus:
“Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson’s disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on clinical experience. Not surprisingly, the scale is subject to both significant intra- and inter-rater variability that are sufficiently large to mask an underlying true difference between an effective intervention and placebo. Digital biomarkers may be able to overcome the limitations of the MDS-UPDRS, as they continuously collects real-time data, during the patient’s day to day activities. In this study the investigators are interested in developing algorithms to track progression of bradykinesia, gait impairment, postural sway, tremor, physical activity, sleep quality, and autonomic dysfunction (the latter being derived from e.g. skin conductance and changes in heart rate variability).”
Pear, Fitbit, Yale insomnia study to start in November after missing June launch date
The focus of this trial is a tweaked version of Pear’s insomnia PDT, Somryst, which the company refers to as PEAR-003b here. The study includes a data-sharing platform called Hugo and equips all participants with a Fitbit Inspire 2:
“This is a multi-center, randomized, controlled trial to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia (i.e., Somryst, herein called PEAR-003b) using a novel patient-centered data sharing platform (called Hugo), with linkage to Fitbit (Inspire 2), among 100 patients with chronic insomnia. Half of the patients with insomnia will receive the PEAR-003b digital therapeutic with linkage to the Hugo platform and Fitbit (Inspire 2) and half of the patients with insomnia will not receive the PDT but will receive a Fitbit and be enrolled in the Hugo platform. The treatment duration will be 9 weeks with a 21-, 35-, and 61-week follow-up.”
LiveWell study on coaches for bipolar wraps up
A Northwestern University single blind, RCT focused on a coach-powered, smartphone-enabled intervention for bipolar disorder wrapped up this past week, but there are no results yet. Details on the intervention are also rather thin:
“Participation in the study lasts for 12 months. Participants are asked to carry a smartphone with them whenever they leave home and wear a wristwatch for measuring activity all day every day. Participants are also asked to complete a series of telephone assessments and may be asked to complete daily check-ins on a smartphone and work with a health coach.”
AppliedVR’s study for sickle cell pushed back until November
Small update on this one: Emory University’s study, Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease, of AppliedVR’s EaseVRx therapeutic is getting started next month instead of this month now:
“This project will evaluate AppliedVR’s EaseVRx – a multi-modal, skills-based, 8-week, virtual reality, home intervention – in an exploratory randomized controlled trial for self-management of chronic pain among Black, young adults (ages 18-40) with sickle cell disease.”
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